A Phase 1/2 interventional study of M7824 and N-803 in Metastatic Castration-resistant Prostate Cancer, Prostate Cancer and Prostate Neoplasm, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment
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Among 202 studies in Prostatic Neoplasms by National Cancer Institute (NCI) — 26 open to participants now, 43 under way, none of them phase 3. Prostatic Neoplasms · National Cancer Institute (NCI).
Among the 202 studies in Prostatic Neoplasms by National Cancer Institute (NCI), this one is the 57th largest by enrollment of the 166 interventional ones that give a count, is one of 8 that started in 2018, is one of 16 in phase 1/2, and was the 162nd registered.
7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →26 of the 202 studies in Prostatic Neoplasms by National Cancer Institute (NCI) are open now, in 2 countries. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18–120 · Men only
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
National Cancer Institute (NCI) · Sites in United States
Ages 18–120 · Men only
National Cancer Institute (NCI) · Sites in United States
Ages 45–75 · Healthy volunteers
National Cancer Institute (NCI) · Sites in United States
Ages 18–120 · Men only
By country, each count listing its studies:
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years to 120 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
202 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 61 · Phase 2 116 · Phase 3 5
First in 1988; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 59 is close to the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 41 across the 166 interventional studies, 1,016 across the 30 observational. Of the 154 that completed or were terminated, 84 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
11 of the studies in Prostatic Neoplasms by National Cancer Institute (NCI) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05588128National Cancer Institute (NCI)Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL | 2026-12-31 |
| NCT04633252National Cancer Institute (NCI)A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer | 2026-12-31 |
| NCT05828082National Cancer Institute (NCI)Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer | 2027-01-01 |
| NCT01834001National Cancer Institute (NCI)Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy | 2027-02-25 |
| NCT03866382National Cancer Institute (NCI)Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors | 2027-02-28 |
Add all 11 to your calendar (.ics) → With an account.
Among the 202 studies in Prostatic Neoplasms by National Cancer Institute (NCI), from their registry updates:
This tab as a report to print or save as PDF → With an account.
Background:
Immunotherapy drugs help the body to fight cancer. Scientists think that combining some of these drugs will make them work better than when used alone. This may be true for many types of cancer, including castration-resistant prostate cancer (CRPC).
Objective:
To test if any of the combinations of drugs below have anti-prostate cancer activity and to test if they are safe.
Eligibility:
People ages 18 and older with CRPC or another metastatic cancer
Design:
Participants will be screened with:
Participants will be treated with a 2-, 3- or 4-drug combinations of the following study drugs in 2-week cycles:
Participants will have physical exams and blood and urine tests at the start of each cycle. They may have scans every 12 weeks.
Participants will continue treatment until their disease gets worse or they cannot tolerate the side effects.
Participants will have a follow-up visit 4-5 weeks after they stop treatment. They will have a physical exam and blood tests. They may be asked to return for scans every 3 months.
Background:
Objective:
-To determine if there is clinical benefit to any of a set of 3 possible treatments for participants with CRPC:
Eligibility:
Design:
Open label Phase I/II trial with following randomization during the expansion.
Phase I: Cohort 1, Arm 1.1
-Up to 18 participants with any solid tumor will be enrolled in dose escalation Cohort 1 for treatment in Arm 1.1 (flat dose of M7824 + different dose levels of N-803).
Phase IIA: expansion with sequential enrollment into Cohort 2A, Arms 2.1A, 2.2A and 2.3 A
Phase IIB: expansion with randomized enrollment into Cohorts 2D and 2R, Arms 2.1B, 2.2B. and 2.3B
If there are >= 6 of 25 participants with a positive signal of activity in any expansion arm, that arm will be considered of interest for future studies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must have or cytologically confirmed any solid tumor (Cohort 1) or castration-resistant prostate cancer (CRPC), Cohorts 2A, 2D and 2R).
For the Cohort 1, eligible participants must have a histologically, cytologically or radiographically proven or locally advanced solid tumor of any type, for which there is no curative standard therapy or standard therapy has failed.
Castrate testosterone level (less than 50ng/dl or 1.7nmol/L). (Participants with a other than prostate cancer are excluded from this criterion).
Radiological confirmation of metastatic disease, or
Progressive disease at study entry defined as one or more of the following criteria occurring in the setting of castrate levels of testosterone:
--Radiographic progression defined as any new or enlarging bone lesions or growing lymph node disease, consistent with prostate cancer
OR
--prostate-specific antigen (PSA) progression defined by sequence of rising values separated by greater than 1 week (2 separate increasing values over a minimum of 1 ng/ml (Prostate Cancer Clinical Trials Working Group 3 (PCWG3) PSA eligibility criteria). If participants had been on flutamide, PSA progression is documented 4 weeks or more after withdrawal. For participants on bicalutamide or nilutamide disease progression is documented 6 or more weeks after withdrawal. The requirement for a 4-6 week withdrawal period following discontinuation of flutamide, nilutamide or bicalutamide only applies to participants who have been on these drugs for at least the prior 6 months. For all other participants they must stop bicalutamide, nilutamide or flutamide the day prior to enrollment.
Asymptomatic or mildly symptomatic form prostate cancer; no use of regularly scheduled opiate analgesics for prostate cancer-related pain. (Participants with a malignancy other than prostate cancer are excluded from this criterion).
Participants must agree to continuation of androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone analogue/antagonist or bilateral orchiectomy. (Participants with a malignancy other than prostate cancer are excluded from this criterion). Participants may also continue oral androgen receptor antagonist/anti-androgen therapy (e.g. enzalutamide or abiraterone) unless enrolling to Arm 2.3A or 2.3B due to concerns regarding Cytochrome P450 (CYP)mediated drug-drug interactions epacadostat.
Participants must have had the following prior therapy:
Testosterone lowering therapy for castration-resistant prostate cancer (CRPC)
In addition to continuation of androgen deprivation therapy (ADT) (unless status post bilateral orchiectomy) eligible patients must have received and had PSA or radiographic progression on enzalutamide (or other oral androgen receptor antagonist e.g. darolutamide or apalutamdide) or abiraterone acetate.
Participants who have tumors known to be microsatellite instability high/mismatch repair deficient or tumor mutational burden high must have received prior pembrolizumab.
Participants with known pathogenic homologous recombination repair mutations for which there is evidence of benefit with poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors (e.g. BReast CAncer gene 1 (BRCA1). BReast CAncer gene 2 (BRCA2), ataxia-telangiectasia mutated (ATM) must have received prior PARP inhibitor.
Age greater than or equal to 18 years.
(ECOG) performance status less than or equal to 1
Participants must have adequate organ and marrow function as defined below:
The effects of Bavarian Nordic (BN)-Brachyury, bintrafusp alfa (M7824), Anktiva (N-803), and Epacadostat on the developing human fetus are unknown. For this reason, men and women must agree to use adequate (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study and maintain such contraception until 4 months following the last dose of any study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her partner s treating physician immediately.
Ability of subject to understand and the willingness to sign a written document.
Participants with successfully treated virus (HCV) are eligible if HCV viral load is undetectable.
EXCLUSION CRITERIA:
Participants who are as follows:
Participants who have undergone peripheral stem cell transplantation, or solid organ transplantation requiring immunosuppression
Prostate cancer participants with a history of brain/, since these participants have a very poor prognosis, and immunotherapy may take time to lead to beneficial clinical effects. Participants with brain or enrolling to arm 1.1 are eligible if they are status post definitive radiotherapy or surgery, and are asymptomatic
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents to be used in the cohort the subject will be enrolled into.
Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin).
Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints.
Participants with prior drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 28 days prior to enrollment, except if the investigator has assessed that all residual treatment-related toxicities have resolved or are minimal and feel the participant is otherwise suitable for enrollment.
Uncontrolled intercurrent acute or chronic illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (> Class I), hepatic disease, unstable angina pectoris, serious cardiac arrhythmia, requiring medication, uncontrolled hypertension (Systolic blood pressure (SBP) >170/ diastolic blood pressure (DBP)>105) or psychiatric illness/social situations within 12 months that would limit compliance with study requirements.
Use of herbal products that may decrease PSA levels (e.g., saw palmetto)
Participants who have had cytotoxic chemotherapy for castration-resistant prostate cancer within the past 3 months. (Participants who have had docetaxel for metastatic castration sensitive per Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) data may enroll as long as they did not have progressive disease while on docetaxel and are 3 months removed from treatment, with all treatment related toxicities resolving to at least grade 1.)
Participants who have undergone major surgery within 4 weeks of enrollment. A will not preclude a participant from starting study.
Participants with a history of (HBV) are excluded due to potential risk for viral reactivation and resulting liver injury in persons with latent HBV
Subjects unwilling to accept blood products or blood transfusions as medically indicated. As there is a risk of severe bleeding with M7824, participants must be willing to receive blood transfusions if medically necessary for their own safety
For participants enrolling in Arm 2.3A and for participants who may be randomized to Arm 2.3B, the following additional exclusion criteria will apply:
Subjects having any history of Serotonin Syndrome (SS) after receiving serotonergic drugs are excluded.
--Participants with a corrected for heart rate by Fridericia's formula (QTcF) interval > 480 milliseconds at the screening are excluded. In the event that a single QTcF is > 480 milliseconds, the subject may enroll if the average QTcF for the 3 (ECG's) is \< 480 milliseconds. For subjects with an intraventricular conduction delay (QRS interval > 120 milliseconds), the corrected JT interval, (JTc) interval may be used in place of the QTc. The JTc must be \< 340 milliseconds if JTc is used in place of the QTc. QTc prolongation due to pacemaker may enroll if the JTc is normal.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bintrafusp alfa (M7824) + Anktiva (N-803)
Biological: M7824 · Drug: N-803 · Drug: Acetaminophen · Drug: Ibuprofen · Drug: Naproxen · Other: Benadryl · Diagnostic Test: EKG · Diagnostic Test: Bone scan · Diagnostic Test: CT chest, abdomen and pelvis · Diagnostic Test: MRI
Bintrafusp alfa (M7824) + Bavarian Nordic (BN)-Brachyury during phase IIA
Biological: M7824 · Biological: MVA-BN-Brachyury · Biological: FPV-Brachyury · Drug: Acetaminophen · Drug: Ibuprofen · Drug: Naproxen · Other: Benadryl · Diagnostic Test: EKG · Diagnostic Test: Bone scan · Diagnostic Test: CT chest, abdomen and pelvis · Diagnostic Test: MRI
Bintrafusp alfa (M7824) + Bavarian Nordic (BN)-Brachyury during phase IIB
Biological: M7824 · Biological: MVA-BN-Brachyury · Biological: FPV-Brachyury · Drug: Acetaminophen · Drug: Ibuprofen · Drug: Naproxen · Other: Benadryl · Diagnostic Test: EKG · Diagnostic Test: Bone scan · Diagnostic Test: CT chest, abdomen and pelvis · Diagnostic Test: MRI
Bintrafusp alfa (M7824) + Bavarian Nordic (BN)-Brachyury + Anktiva (N-803) during phase IIA
Biological: M7824 · Drug: N-803 · Biological: MVA-BN-Brachyury · Biological: FPV-Brachyury · Drug: Acetaminophen · Drug: Ibuprofen · Drug: Naproxen · Other: Benadryl · Diagnostic Test: EKG · Diagnostic Test: Bone scan · Diagnostic Test: CT chest, abdomen and pelvis · Diagnostic Test: MRI
Bintrafusp alfa (M7824) + Bavarian Nordic (BN)-Brachyury + Anktiva (N-803) during phase IIB
Biological: M7824 · Drug: N-803 · Biological: MVA-BN-Brachyury · Biological: FPV-Brachyury · Drug: Acetaminophen · Drug: Ibuprofen · Drug: Naproxen · Other: Benadryl · Diagnostic Test: EKG · Diagnostic Test: Bone scan · Diagnostic Test: CT chest, abdomen and pelvis · Diagnostic Test: MRI
Bintrafusp alfa (M7824) + Bavarian Nordic (BN)-Brachyury + Anktiva (N-803) + Epacadostat during phase IIA
Biological: M7824 · Drug: N-803 · Biological: MVA-BN-Brachyury · Biological: FPV-Brachyury · Drug: Epacadostat · Drug: Acetaminophen · Drug: Ibuprofen · Drug: Naproxen · Other: Benadryl · Diagnostic Test: EKG · Diagnostic Test: Bone scan · Diagnostic Test: CT chest, abdomen and pelvis · Diagnostic Test: MRI
Bintrafusp alfa (M7824) + Bavarian Nordic (BN)-Brachyury + Anktiva (N-803) + Epacadostat during phase IIB
Biological: M7824 · Drug: N-803 · Biological: MVA-BN-Brachyury · Biological: FPV-Brachyury · Drug: Epacadostat · Drug: Acetaminophen · Drug: Ibuprofen · Drug: Naproxen · Other: Benadryl · Diagnostic Test: EKG · Diagnostic Test: Bone scan · Diagnostic Test: CT chest, abdomen and pelvis · Diagnostic Test: MRI
1,200 mg intravenous (IV) once every 2 weeks.
Also known as: Bintrafusp alfa
8-15 mcg/kg subcutaneous every 2 weeks.
Also known as: Anktiva
MVA-BN-Brachyury will be administered subcutaneously (2 doses 2 weeks apart).
Also known as: modified vaccinia Ankara Bavarian Nordic Brachyury
FPV-Brachyury will be given 2 weeks after second dose of modified vaccinia Ankara (MVA)-Bavarian Nordic (BN)-Brachyury, then every 4 weeks until 6 months, then every 3 months for 2 years, then every 6 months.
Also known as: Fowlpox Virus Brachyury
600 mg orally twice daily (1200 MG total).
Also known as: IDO1
Antipyretic medication, orally, prior to infusion, up to 650mg.
Also known as: Tylenol, Ofirmev, FeverAll
Antipyretic medication, orally, prior to infusion, up to 600mg.
Also known as: Advil, Advil Migraine
Antipyretic medication, orally, prior to infusion, up to 500mg.
Also known as: Aleve, Naprosyn, Anaprox DS
50mg orally prior to infusion.
Also known as: Diphenhydramine
Baseline and principal investigator discretion.
Also known as: Electrocardiogram
Restaging every 12 weeks.
Also known as: Bone scintigraphy
Every 12 weeks after start of therapy.
Also known as: Computed tomography chest, abdomen and pelvis
If clinically indicated.
Also known as: Magnetic resonance imaging
Clinical Benefit With Any of a Set of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Reported With an 80% Confidence Interval
Objective clinical response and/or prostate-specific antigen (PSA) decline of \>=30% sustained for a minimum of 21 days. Any of these is considered 'clinical benefit.' Objective response was assessed by the response evaluation criteria in solid tumors (RECIST) 1.1. Complete response (CR) is disappearance of all non-target lesions and normalization of tumor marker level. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Three treatments evaluated are: Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824), Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803), and Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803) + Epacadostat.
Time frame: From enrollment up to 49 weeks
Clinical Benefit(Objective Response if Measurable Disease by Response Evaluation Criteria in Solid Tumors v1.1)With Any of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer Reported With a 95% Confidence Interval
Objective response was assessed by the response evaluation criteria in solid tumors (RECIST) 1.1. Complete response (CR) is disappearance of all non-target lesions and normalization of tumor marker level. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Three treatments evaluated are: Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824), Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803), and Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803) + Epacadostat.
Time frame: From enrollment up to 49 weeks
Phase I/II: Number of Participants With Grades 3, 4, and/or 5 Serious and/or Non-serious Dose-limiting Toxicities (DLT)
A DLT is defined as any of the following adverse events (AE) possibly related to study drugs that occur within 21 days of the start of treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 3 is moderate. Grade 4 is life-threatening, and Grade 5 is death related to AE. A DLT is any grade ≥ 4 hematologic toxicity or grade 3 thrombocytopenia with associated bleeding; any grade ≥ 3 non-hematologic toxicity, except for any of the following: transient (≤ 48 hour) grade 3 fatigue, local reactions, flu-like symptoms, fever, headache, or nausea, emesis, and diarrhea; or CTCAE Grade 3 skin toxicity lasting less than five days. A non-serious AE is any untoward medical occurrence. A serious AE is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect.
Time frame: Within 21 days of the start of treatment
6-month Progression Free Survival (PFS) Probability
6-month progression free survival was measured from the on-study date until progression or death without progression in participants and reported with a 95% confidence interval. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
Time frame: 6-months
Number of Participants With Grades 1, 2, 3, and 4 Non-serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Number of participants with grades 1, 2, 3, and 4 non-serious adverse events related to treatment treated with combinations and Bintrafusp alfa (M7824) + Anktiva (N-803).
Time frame: 3 weeks dose-limiting toxicity (DLT) period
Number of Participants With Grades 3, 4, and/or 5 Serious Adverse Events Related to Treatment Treated With Combinations and Bintrafusp Alfa (M7824) + Anktiva (N-803)
Number of participants with grades 3 4, and/or 5 serious adverse events related to treatment treated with combinations and Bintrafusp alfa (M7824) + Anktiva (N-803).
Time frame: 3 weeks dose-limiting toxicity (DLT) period
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.
| Milestone | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A |
|---|---|---|---|---|---|---|---|
| Started | 4 | 10 | 1 | 0 | 0 | 0 | 0 |
| Completed | 4 | 9 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Ineligible | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: New therapy | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A |
|---|---|---|---|---|---|---|---|
| Started | 4 | 9 | 0 | 13 | 13 | 12 | 6 |
| Follow up period completed | 2 | 5 | 0 | 7 | 11 | 7 | 6 |
| Disease progression on study | 1 | 2 | 0 | 7 | 8 | 9 | 1 |
| Completed | 4 | 9 | 0 | 10 | 12 | 11 | 6 |
| Not completed | 0 | 0 | 0 | 3 | 1 | 1 | 0 |
| Withdrew: Refused further treatment | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Switched to alternative therapy | 0 | 0 | 0 | 3 | 0 | 0 | 0 |
Objective clinical response and/or prostate-specific antigen (PSA) decline of \>=30% sustained for a minimum of 21 days. Any of these is considered 'clinical benefit.' Objective response was assessed by the response evaluation criteria in solid tumors (RECIST) 1.1. Complete response (CR) is disappearance of all non-target lesions and normalization of tumor marker level. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Three treatments evaluated are: Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824), Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803), and Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803) + Epacadostat.
| Proportion of participants | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A |
|---|---|---|---|
| Clinical Benefit With Any of a Set of 3 Possible Treatments for Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Reported With an 80% Confidence Interval | .076 (0.0081 to 0.268) | 0.292 (0.170 to 0.442) | 0 (0.000 to 0.319) |
Objective response was assessed by the response evaluation criteria in solid tumors (RECIST) 1.1. Complete response (CR) is disappearance of all non-target lesions and normalization of tumor marker level. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. Three treatments evaluated are: Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824), Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803), and Phase II Bavarian Nordic (BN) Brachyury + Bintrafusp alfa (M7824) + Anktiva (N-803) + Epacadostat.
| Proportion of participants | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | All Participants in Phase IIA Dose Expansion and Phase IIB Dose Expansion | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A |
|---|---|---|---|
| Complete Response | 0 (0.000 to 0.708) | 0 (0.000 to 0.459) | 0 (0.000 to 0.975) |
| Partial Response | 0 (0.000 to 0.708) | 0.33 (0.0433 to 0.777) | 0 (0.000 to 0.975) |
| Stable Disease | 0.33 (0.0084 to 0.906) | 0 (0.000 to 0.459) | 0 (0.000 to 0.975) |
| Progressive Disease | 0.67 (0.0943 to 0.9916) | 0.67 (0.223 to 0.957) | 1 (0.025 to 1.000) |
A DLT is defined as any of the following adverse events (AE) possibly related to study drugs that occur within 21 days of the start of treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 3 is moderate. Grade 4 is life-threatening, and Grade 5 is death related to AE. A DLT is any grade ≥ 4 hematologic toxicity or grade 3 thrombocytopenia with associated bleeding; any grade ≥ 3 non-hematologic toxicity, except for any of the following: transient (≤ 48 hour) grade 3 fatigue, local reactions, flu-like symptoms, fever, headache, or nausea, emesis, and diarrhea; or CTCAE Grade 3 skin toxicity lasting less than five days. A non-serious AE is any untoward medical occurrence. A serious AE is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, or congenital anomaly/birth defect.
| Participants | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A |
|---|---|---|---|---|---|---|
| Grade 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Grade 5 | 0 | 0 | 0 | 0 | 0 | 0 |
6-month progression free survival was measured from the on-study date until progression or death without progression in participants and reported with a 95% confidence interval. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
| proportion probability | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | All Participants in Phase IIA Dose Expansion and Phase IIB, Dose Expansion |
|---|---|---|---|
| 6-month Progression Free Survival (PFS) Probability | 0.354 (0.152 to 0.822) | 0.348 (0.196 to 0.617) | NA (NA to NA) |
Number of participants with grades 1, 2, 3, and 4 non-serious adverse events related to treatment treated with combinations and Bintrafusp alfa (M7824) + Anktiva (N-803).
| Participants | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A |
|---|---|---|---|---|---|---|
| Grade 1 Anorexia possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 4 | 0 | 0 |
| Grade 1 Arthralgia possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Aspartate aminotransferase increased possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Bloating possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Blood and lymphatic system disorders possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Chills possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 3 | 0 | 0 |
| Grade 1 Diarrhea possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Dizziness possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 1 |
| Grade 1 Endocrine disorders - Other specify possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 2 | 0 | 0 |
| Grade 1 Fatigue possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 3 | 4 | 0 | 1 |
| Grade 1 Fever possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 5 | 0 | 0 |
| Grade 1 Flatulence possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Flu-like symptoms possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 6 | 0 | 2 |
| Grade 1 Headache possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Hematuria possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Hyperhidrosis possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Injection site reaction possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Insomnia possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Malaise possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Myalgia possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Nausea possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 2 | 0 | 0 |
| Grade 1 Pruritus possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Skin and subcutaneous tissue disorders possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Vertigo possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Vomiting possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Chills probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Dizziness probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Fatigue probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 2 | 0 | 0 | 0 |
| Grade 1 Fever probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 2 | 0 | 0 | 0 |
| Grade 1 Flu-like symptoms probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 2 | 0 | 0 | 0 |
| Grade 1 Headache probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Hyperthyroidism probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Injection site reaction probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 5 | 0 | 0 | 0 |
| Grade 1 Malaise probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Nausea probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 2 | 0 | 0 | 0 |
| Grade 1 Pain probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Chills definitely related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 2 | 0 | 0 | 0 |
| Grade 1 Fever definitely related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Injection site reaction definitely related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 9 | 7 | 0 | 2 |
| Grade 1 Pruritus definitely related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Skin and subcutaneous tissue disorders definitely related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Alanine aminotransferase increased possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Dehydration possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Endocrine disorders - Other specify possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 2 | 0 | 1 |
| Grade 2 Fatigue possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 1 |
| Grade 2 Fever possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Flu-like symptoms possibly related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Chills probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Hyperhidrosis probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Injection site reaction probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Lipase increased probably related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Injection site reaction definitely related to Bavarian-Nordic (BN)-brachyury | 0 | 0 | 2 | 1 | 0 | 0 |
| Grade 1 Abdominal pain possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Anorexia possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Fatigue possibly related to Anktiva (N803)0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Grade 1 Insomnia possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Mucositis oral possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Pruritus possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 2 |
| Grade 1 Rash maculo-papular possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Weight loss possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Pruritus probably related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Rash maculo-papular probably related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 4 |
| Grade 1 Hemoglobinuria definitely related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Anorexia possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Fatigue possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Mucositis oral possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Rash maculo-papular possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Weight loss possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Pruritus probably related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Rash maculo-papular probably related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 3 |
| Grade 3 Rash maculo-papular possibly related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Pruritus probably related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Rash maculo-papular probably related to Anktiva (N803) | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Abdominal pain possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Anorexia possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Fatigue possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 2 |
| Grade 1 Insomnia possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Mucositis oral possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Pruritus possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 2 |
| Grade 1 Rash maculo-papular possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Weight loss possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Pruritus probably related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Rash maculo-papular probably related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 4 |
| Grade 1 Hemoglobinuria definitely related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Anorexia possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Fatigue possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Mucositis oral possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Weight loss possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Pruritus probably related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Rash maculo-papular probably related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 3 |
| Grade 2 Rash maculo-papular possibly related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Pruritus probably related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Rash maculo-papular probably related to Epacadostat | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Abdominal pain possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Alanine aminotransferase increased possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Anal hemorrhage possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Anorexia possibly related to M7824 | 0 | 2 | 0 | 1 | 0 | 0 |
| Grade 1 Aspartate aminotransferase increased possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Bloating possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Blood and lymphatic system disorders - Other specify possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Chills possibly related to M7824 | 2 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Dry mouth possibly related to M7824 | 0 | 0 | 1 | 2 | 0 | 0 |
| Grade 1 Dry skin possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Endocrine disorders - Other specify possibly related to M7824 | 0 | 0 | 0 | 2 | 0 | 0 |
| Grade 1 Eosinophilia possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Epistaxis possibly related to M7824 | 0 | 1 | 0 | 3 | 0 | 1 |
| Grade 1 Eye disorders - Other specify possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Fatigue possibly related to M7824 | 1 | 3 | 6 | 3 | 0 | 0 |
| Grade 1 Fever possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Flatulence possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Flu-like symptoms possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Gastrointestinal disorders - Other specify possibly related to M7824 | 0 | 0 | 3 | 2 | 0 | 0 |
| Grade 1 Generalized muscle weakness possibly related to M7824 | 1 | 0 | 0 | 0 | 0 | 0 |
| Grade 1 Headache possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Hematuria possibly related to M7824 | 0 | 1 | 3 | 1 | 0 | 1 |
| Grade 1 Hemolysis possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 1 |
| Grade 1 Hemorrhoidal hemorrhage possibly related to M7824 | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Hoarseness possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Hypothyroidism possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Insomnia possibly related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Malaise possibly related to M7824 | 0 | 1 | 1 | 0 | 0 | 0 |
| Grade 1 Mucositis oral possibly related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Nausea possibly related to M7824 | 0 | 2 | 1 | 0 | 0 | 0 |
| Grade 1 Pain possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Pruritus possibly related to M7824 | 0 | 2 | 0 | 3 | 0 | 2 |
| Grade 1 Rash maculo-papular possibly related to M7824 | 0 | 1 | 2 | 3 | 0 | 1 |
| Grade 1 Sinus tachycardia possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Skin and subcutaneous tissue disorders - Other specify possibly related to M7824 | 0 | 1 | 1 | 1 | 0 | 0 |
| Grade 1 Thyroid stimulating hormone possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Alanine aminotransferase increased probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Alkaline phosphatase increased probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Aspartate aminotransferase increased probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Cystitis noninfective probably related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Dry skin probably related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Endocrine disorders - Other specify probably related to M7824 | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Enterocolitis probably related to M7824 | 0 | 2 | 0 | 0 | 0 | 0 |
| Grade 1 Eosinophilia probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Fatigue probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Gastrointestinal disorders - Other specify probably related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 General disorders and administration site conditions probably related to M7824 | 0 | 0 | 0 | 2 | 0 | 0 |
| Grade 1 Gingival pain probably related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Hematuria probably related to M7824 | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Hyperthyroidism probably related to M7824 | 0 | 0 | 1 | 1 | 0 | 1 |
| Grade 1 Hypotension probably related to M7824 | 1 | 0 | 0 | 0 | 0 | 0 |
| Grade 1 Hypothyroidism probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 1 |
| Grade 1 Lipase increased probably related to M7824 | 0 | 0 | 0 | 3 | 0 | 1 |
| Grade 1 Metabolism and nutrition disorders - Other specify probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Neoplasms benign, malignant and unspecified incl cysts and polyps probably related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Oral hemorrhage probably related to M7824 | 0 | 0 | 2 | 0 | 0 | 1 |
| Grade 1 Pruritus probably related to M7824 | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Rash acneiform probably related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Rash maculo-papular probably related to M7824 | 1 | 3 | 0 | 5 | 0 | 0 |
| Grade 1 Serum amylase probably related to M7824 | 0 | 0 | 0 | 2 | 0 | 0 |
| Grade 1 Skin and subcutaneous tissue disorders - Other specify probably related to M7824 | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Thyroid stimulating hormone increased probably related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Bullous dermatitis definitely related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Hyperkeratosis definitely related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Hypothyroidism definitely related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Infusion related reaction definitely related to M7824 | 1 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Injection site reaction definitely related to M7824 | 0 | 2 | 0 | 0 | 0 | 0 |
| Grade 1 Paresthesia definitely related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Periorbital edema probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Skin and subcutaneous tissue disorders - Other specify definitely related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Alanine aminotransferase increased possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Anal hemorrhage possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Anemia possibly related to M7824 | 0 | 2 | 0 | 1 | 0 | 1 |
| Grade 2 Diarrhea possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Dry mouth possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Endocrine disorders - Other specify possibly related to M7824 | 0 | 0 | 0 | 2 | 0 | 1 |
| Grade 2 Eye disorders possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Fatigue possibly related to M7824 | 0 | 3 | 1 | 1 | 0 | 0 |
| Grade 2 Fever possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 General disorders and administration site conditions-Other specify possibly related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Hematuria possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 2 |
| Grade 2 Hypotension possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Joint range of motion decreased possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Lipase increased possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Lymphocyte count decreased possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Mucositis oral possibly related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Musculoskeletal and connective tissue disorder Other specify possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Nausea possibly related to M7824 | 1 | 0 | 0 | 0 | 0 | 0 |
| Grade 2 Pain possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Proteinuria possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Pruritus possibly related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Rash maculo-papular possibly related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Skin and subcutaneous tissue disorders Other specify possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Small intestine ulcer possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Vomiting possibly related to M7824 | 2 | 0 | 0 | 0 | 0 | 0 |
| Grade 2 Anemia probably related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Bullous dermatitis probably related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Dry mouth probably related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Endocrine disorders - Other specify probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Eye disorders probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Hyperthyroidism probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Hypothyroidism probably related to M7824 | 0 | 1 | 1 | 2 | 0 | 0 |
| Grade 2 Infusion related reaction probably related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Lipase increased probably related to M7824 | 0 | 0 | 0 | 4 | 0 | 1 |
| Grade 2 Proctitis probably related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Rash maculo-papular probably related to M7824 | 0 | 1 | 0 | 2 | 0 | 0 |
| Grade 2 Serum amylase probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Skin and subcutaneous tissue disorders - Other specify probably related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Urticaria probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Arthritis definitely related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Infusion related reaction definitely related to M7824 | 0 | 0 | 0 | 1 | 0 | 2 |
| Grade 2 Pruritus definitely related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Skin and subcutaneous tissue disorders Other specify definitely related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Anemia possibly related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Blood and lymphatic system disorders Other specify possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Gastrointestinal disorders Other specify possibly related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 3 Rash maculopapular possibly related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Eosinophilia probably related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Lipase increased probably related to M7824 | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Pancreatitis probably related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Alanine aminotransferase increased possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Aspartate aminotransferase increased possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Dizziness possibly related to research | 0 | 0 | 0 | 1 | 0 | 1 |
| Grade 1 Dry skin possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Endocrine disorders Other specify possibly related to research | 0 | 0 | 0 | 2 | 0 | 0 |
| Grade 1 Eosinophilia possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Eye disorders Other specify possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Fever possibly related to research | 0 | 0 | 0 | 5 | 0 | 0 |
| Grade 1 Hemolysis possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Hyperhidrosis possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Injection site reaction possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Insomnia possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Malaise possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Mucositis oral possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Myalgia possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Vertigo possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Weight loss possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Anal hemorrhage possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Arthralgia possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Bloating possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Blood and lymphatic system disorders Other specify possibly related to research | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Diarrhea possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Dry mouth possibly related to research | 0 | 0 | 1 | 2 | 0 | 0 |
| Grade 1 Flatulence possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Flu-like symptoms possibly related to research | 0 | 0 | 1 | 6 | 0 | 2 |
| Grade 1 Hemorrhoidal hemorrhage possibly related to research | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Hoarseness possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Hypothyroidism possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Sinus tachycardia possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Vomiting possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Pain possibly related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Thyroid stimulating hormone possibly related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Alanine aminotransferase increased probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Alkaline phosphatase increased probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Aspartate aminotransferase increased probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Eosinophilia probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Gastrointestinal disorders Other specify probably related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Hypothyroidism probably related to research | 0 | 0 | 0 | 1 | 0 | 1 |
| Grade 1 Lipase increased probably related to research | 0 | 0 | 0 | 3 | 0 | 1 |
| Grade 1 Metabolism and nutrition disorders Other specify probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Periorbital edema probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Serum amylase probably related to research | 0 | 0 | 0 | 2 | 0 | 0 |
| Grade 1 Cystitis noninfective probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Dry skin probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Endocrine disorders Other specify probably related to research | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Hematuria probably related to research | 0 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Oral hemorrhage probably related to research | 0 | 0 | 2 | 0 | 0 | 1 |
| Grade 1 Gastrointestinal disorders Other specify possibly related to research | 0 | 0 | 3 | 2 | 0 | 0 |
| Grade 1 Abdominal pain possibly related to research | 0 | 1 | 0 | 0 | 0 | 1 |
| Grade 1 Epistaxis possibly related to research | 0 | 1 | 0 | 3 | 0 | 1 |
| Grade 1 Anorexia possibly related to research | 0 | 1 | 0 | 5 | 0 | 1 |
| Grade 1 Diarrhea probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 General disorders& administration site conditions Other specify probably related to research | 0 | 1 | 0 | 2 | 0 | 0 |
| Grade 1 Generalized edema probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Gingival pain probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Hyperhidrosis probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Myalgia probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Neoplasms benign, malignant and unspecified Other specify probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Rash acneiform probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Thyroid stimulating hormone probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Vomiting probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Malaise probably related to research | 0 | 1 | 1 | 0 | 0 | 0 |
| Grade 1 Enterocolitis probably related to research | 0 | 2 | 0 | 0 | 0 | 0 |
| Grade 1 Anorexia probably related to research | 0 | 3 | 0 | 0 | 0 | 1 |
| Grade 1 Headache probably related to research | 0 | 3 | 1 | 0 | 0 | 0 |
| Grade 1 Nausea probably related to research | 0 | 3 | 2 | 1 | 0 | 0 |
| Grade 1 Fatigue possibly related to research | 0 | 3 | 4 | 3 | 0 | 2 |
| Grade 1 Chills possibly related to research | 1 | 0 | 0 | 3 | 0 | 0 |
| Grade 1 Generalized muscle weakness possibly related to research | 1 | 0 | 0 | 0 | 0 | 0 |
| Grade 1 Dizziness probably related to research | 1 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Pain probably related to research | 1 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Skin and subcutaneous tissue disorders Other specify probably related to research | 1 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Fatigue probably related to research | 1 | 0 | 2 | 1 | 0 | 0 |
| Grade 1 Flu-like symptoms probably related to research | 1 | 2 | 2 | 2 | 0 | 0 |
| Grade 1 Rash maculo-papular probably related to research | 1 | 3 | 0 | 5 | 0 | 4 |
| Grade 1 Injection site reaction probably related to research | 1 | 7 | 5 | 2 | 0 | 0 |
| Grade 1 Hypotension probably related to research | 2 | 0 | 0 | 0 | 0 | 0 |
| Grade 1 Pruritus probably related to research | 2 | 1 | 1 | 2 | 0 | 1 |
| Grade 1 Fever probably related to research | 2 | 5 | 2 | 0 | 0 | 0 |
| Grade 1 Chills probably related to research | 3 | 8 | 1 | 0 | 0 | 0 |
| Grade 1 Hyperthyroidism probably related to research | 0 | 0 | 1 | 2 | 0 | 1 |
| Grade 1 Flu-like symptoms definitely related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Hemoglobinuria definitely related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Hypothyroidism definitely related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Paresthesia definitely related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Hyperkeratosis definitely related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 1 Skin and subcutaneous tissue disorders Other specify definitely related to research | 0 | 0 | 2 | 0 | 0 | 0 |
| Grade 1 Bullous dermatitis definitely related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Hemolysis definitely related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 1 Fever definitely related to research | 0 | 1 | 1 | 1 | 0 | 0 |
| Grade 1 Nausea possibly related to research | 0 | 1 | 1 | 3 | 0 | 0 |
| Grade 1 Headache possibly related to research | 0 | 1 | 1 | 1 | 0 | 0 |
| Grade 1 Skin and subcutaneous tissue disorders Other specify possibly related to research | 0 | 1 | 1 | 1 | 0 | 0 |
| Grade 1 Rash maculo-papular possibly related to research | 0 | 1 | 2 | 3 | 0 | 1 |
| Grade 1 Hematuria possibly related to research | 0 | 1 | 3 | 1 | 0 | 1 |
| Grade 1 Pruritus possibly related to research | 0 | 2 | 0 | 2 | 0 | 2 |
| Grade 1 Chills definitely related to research | 0 | 2 | 2 | 0 | 0 | 0 |
| Grade 1 Infusion related reaction definitely related to research | 1 | 0 | 0 | 1 | 0 | 0 |
| Grade 1 Edema limbs definitely related to research | 1 | 0 | 0 | 0 | 0 | 0 |
| Grade 1 Skin induration definitely related to research | 1 | 0 | 0 | 0 | 0 | 0 |
| Grade 1 Pain definitely related to research | 1 | 0 | 0 | 0 | 0 | 0 |
| Grade 1 Pruritus definitely related to research | 1 | 0 | 1 | 1 | 0 | 0 |
| Grade 1 Injection site reaction definitely related to research | 4 | 9 | 9 | 10 | 0 | 6 |
| Grade 2 Weight loss possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Alanine aminotransferase increased possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Anorexia possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 1 Dehydration possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Endocrine disorders - Other specify possibly related to research | 0 | 0 | 0 | 1 | 0 | 1 |
| Grade 2 Eye disorders Other specify possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Hypotension possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Lipase increased possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Anal hemorrhage possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Diarrhea possibly related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Headache possibly related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Neutrophil count decreased | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Pain possibly related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Proteinuria possibly related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Sinusitis possibly related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Fatigue possibly related to research | 0 | 1 | 1 | 1 | 0 | 1 |
| Grade 2 Lymphocyte count decreased possibly related to research | 0 | 3 | 0 | 0 | 0 | 0 |
| Grade 2 Anemia possibly related to research | 0 | 3 | 0 | 1 | 0 | 1 |
| Grade 2 Alkaline phosphatase increased possibly related to research | 1 | 0 | 0 | 0 | 0 | 0 |
| Grade 2 Vomiting possibly related to research | 2 | 0 | 0 | 0 | 0 | 0 |
| Grade 2 Nausea possibly related to research | 2 | 0 | 0 | 0 | 0 | 0 |
| Grade 2 Eye disorders Other specify probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Fever possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Flu-like symptoms possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 General disorders& administration site conditions Other specify possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Hematuria possibly related to research | 0 | 0 | 0 | 1 | 0 | 2 |
| Grade 2 Joint range of motion decreased possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Mucositis oral possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Musculoskeletal and connective tissue disorder Other specify possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Rash maculo-papular possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Skin and subcutaneous tissue disorders Other specify possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Hyperthyroidism probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Lipase increased probably related to research | 0 | 0 | 0 | 4 | 0 | 1 |
| Grade 2 Pruritus probably related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Serum amylase probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Skin and subcutaneous tissue disorders Other, specify, probably related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Urticaria probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 Dry mouth probably related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Endocrine disorders other specify probably related to research | 0 | 0 | 0 | 2 | 0 | 0 |
| Grade 2 Hematuria probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Chills probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Infusion related reaction probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Proctitis probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Hyperhidrosis probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Anemia probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Bullous dermatitis probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Dehydration probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Hyponatremia probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Nausea probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Rash maculo-papular probably related to research | 0 | 1 | 0 | 2 | 0 | 3 |
| Grade 2 Hypothyroidism probably related to research | 0 | 1 | 1 | 2 | 0 | 0 |
| Grade 2 Injection site reaction probably related to research | 0 | 1 | 1 | 1 | 0 | 1 |
| Grade 2 Fatigue probably related to research | 0 | 2 | 0 | 0 | 0 | 0 |
| Grade 2 Fever probably related to research | 1 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Infusion related reaction definitely related to research | 0 | 0 | 0 | 1 | 0 | 2 |
| Grade 2 Skin and subcutaneous tissue disorders Other specify definitely related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 2 Arthritis definitely related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 2 Injection site reaction definitely related to research | 0 | 2 | 3 | 7 | 0 | 3 |
| Grade 2 Pruritus definitely related to research | 1 | 2 | 0 | 0 | 0 | 0 |
| Grade 3 Anemia possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Blood and lymphatic system disorders Other specify possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Gastrointestinal disorders possibly related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 3 Eosinophilia probably related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Lipase increased probably related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Pruritus probably related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Rash maculo-papular possibly related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Rash maculo-papular probably related to research | 0 | 0 | 0 | 0 | 0 | 1 |
| Grade 3 Pancreatitis probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 2 Small intestine ulcer possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 2 injection site reaction definitely related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
Number of participants with grades 3 4, and/or 5 serious adverse events related to treatment treated with combinations and Bintrafusp alfa (M7824) + Anktiva (N-803).
| Participants | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A |
|---|---|---|---|---|---|---|
| Grade 3 Metabolism and nutrition disorders - Other, specify possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Metabolism and nutrition disorders - Other, specify possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 3 Tumor hemorrhage possibly related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 3 Tumor hemorrhage possibly related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 3 Endocrine disorders - Other specify probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 3 Endocrine disorders - Other specify probably related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 3 Enterocolitis probably related to research | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 3 Enterocolitis probably related to M7824 | 0 | 1 | 0 | 0 | 0 | 0 |
| Grade 3 Tumor hemorrhage probably related to research | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 3 Tumor hemorrhage probably related to M7824 | 0 | 0 | 1 | 0 | 0 | 0 |
| Grade 4 Blood and lymphatic system disorders - Other specify possibly related to research | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 4 Blood and lymphatic system disorders - Other specify possibly related to M7824 | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 4 Blood and lymphatic system disorders - Other specify possibly related to Anktiva (N-803) | 0 | 0 | 0 | 1 | 0 | 0 |
| Grade 5 related to research and/or any study treatment | 0 | 0 | 0 | 0 | 0 | 0 |
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
| Participants | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A |
|---|---|---|---|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 4 | 10 | 13 | 13 | 12 | 6 |
Collected over Adverse Events were monitored/assessed from the first study intervention, up to 49 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | 1/4 (25%) | 3/4 (75%) | 4/4 (100%) |
| Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | 2/10 (20%) | 5/10 (50%) | 10/10 (100%) |
| Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | 1/13 (7.7%) | 8/13 (61.5%) | 13/13 (100%) |
| Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | 0/13 (0%) | 5/13 (38.5%) | 13/13 (100%) |
| Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | 0/12 (0%) | 3/12 (25%) | 12/12 (100%) |
| Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | 0/6 (0%) | 2/6 (33.3%) | 6/6 (100%) |
| Event | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A |
|---|---|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 1/4 | 0/10 | 0/13 | 0/13 | 0/12 | 0/6 |
| ConstipationGastrointestinal disorders | 1/4 | 0/10 | 0/13 | 0/13 | 0/12 | 0/6 |
| Muscle weakness upper limbMusculoskeletal and connective tissue disorders | 1/4 | 0/10 | 0/13 | 0/13 | 0/12 | 0/6 |
| NauseaGastrointestinal disorders | 1/4 | 0/10 | 0/13 | 0/13 | 0/12 | 0/6 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/4 | 0/10 | 0/13 | 0/13 | 0/12 | 0/6 |
| Urinary tract infectionInfections and infestations | 1/4 | 0/10 | 0/13 | 1/13 | 0/12 | 0/6 |
| VomitingGastrointestinal disorders | 1/4 | 0/10 | 0/13 | 0/13 | 0/12 | 0/6 |
| Tumor hemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/4 | 2/10 | 1/13 | 0/13 | 0/12 | 0/6 |
| Gastrointestinal disorders - Other, specify: colitisGastrointestinal disorders | 0/4 | 0/10 | 0/13 | 0/13 | 0/12 | 1/6 |
| General disorders and administration site conditions - Other, specify: Mucosal bleedingGeneral disorders | 0/4 | 0/10 | 0/13 | 0/13 | 0/12 | 1/6 |
| Event | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A |
|---|---|---|---|---|---|---|
| Injection site reactionGeneral disorders | 4/4 | 10/10 | 11/13 | 13/13 | 12/12 | 6/6 |
| AnemiaBlood and lymphatic system disorders | 2/4 | 9/10 | 3/13 | 4/13 | 4/12 | 2/6 |
| ChillsGeneral disorders | 3/4 | 9/10 | 3/13 | 4/13 | 1/12 | 0/6 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 1/4 | 3/10 | 2/13 | 6/13 | 2/12 | 5/6 |
| HeadacheNervous system disorders | 0/4 | 8/10 | 2/13 | 1/13 | 2/12 | 0/6 |
| PruritusSkin and subcutaneous tissue disorders | 3/4 | 4/10 | 3/13 | 6/13 | 0/12 | 4/6 |
| FeverGeneral disorders | 2/4 | 7/10 | 3/13 | 6/13 | 0/12 | 0/6 |
| Flu like symptomsGeneral disorders | 1/4 | 2/10 | 4/13 | 9/13 | 8/12 | 3/6 |
| PainGeneral disorders | 1/4 | 4/10 | 9/13 | 7/13 | 1/12 | 3/6 |
| AnorexiaMetabolism and nutrition disorders | 1/4 | 5/10 | 1/13 | 8/13 | 5/12 | 2/6 |
Data collected for one participant who was enrolled and not treated is reported here.
| Age, Categorical(Participants) | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 9 | 1 | 5 | 6 | 6 | 1 | 31 |
| >=65 years | 1 | 1 | 0 | 8 | 7 | 6 | 5 | 28 |
| Age, Continuous(years) | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 54.23 ± 12.56 | 52.34 ± 12.05 | 50.5 ± 0 | 67.81 ± 9.23 | 65.69 ± 6.81 | 66.57 ± 6.97 | 75.47 ± 8.44 | 64.03 ± 11.19 |
| Sex: Female, Male(Participants) | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 3 | 4 | 1 | 0 | 0 | 0 | 0 | 8 |
| Male | 1 | 6 | 0 | 13 | 13 | 12 | 6 | 51 |
| Ethnicity (NIH/OMB)(Participants) | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 0 | 1 | 2 | 0 | 0 | 6 |
| Not Hispanic or Latino | 3 | 7 | 1 | 12 | 9 | 12 | 6 | 50 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Asian | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 4 | 1 | 5 | 0 | 10 |
| White | 3 | 9 | 1 | 8 | 8 | 7 | 6 | 42 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 3 | 0 | 0 | 4 |
| Region of Enrollment(participants) | Phase (Ph) I Dose Escalation, Cohort 1, Arm 1.1, Dose Level (DL) 1 | Phase I Dose Escalation, Cohort 1, Arm 1.1 Dose Level 2 | Phase I Dose Escalation, Cohort 1: Enrolled But Not Treated | Phase IIA Dose Expansion (Dose Exp.), Cohort 2, Arm 2.1A | Phase IIA Dose Expansion, Cohort 2, Arm 2.2A | Phase IIB, Dose Expansion, Cohort 2, Arm 2.2B | Phase IIA Dose Expansion, Cohort 2A, Arm 2.3A | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 4 | 10 | 1 | 13 | 13 | 12 | 6 | 59 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
Access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
Ran from May 2018 to primary completion in Oct 2024, 77 months.
Results were first posted in Jun 2025, 8 months after primary completion.
Of 114 non-industry phase 1/2 interventional studies under Prostatic Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 85. This study's 77 months is above that.
Counting every sponsor, half of 211 studies reached it within 61 months; a quarter within 30 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Nogapendekin alfa inbakicept · Epacadostat
National Cancer Institute (NCI) →