A Phase 2 interventional study of Antigen direct immunotherapy: PROSTVAC-V and Antigen direct immunotherapy: PROSTVAC-F in Prostate Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by National Cancer Institute (NCI) · Phase 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 85th largest by enrollment of the 166 interventional ones that give a count, is one of 8 that started in 2018, is one of 100 in phase 2, and was the 154th 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 and older · male · 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 40 is below 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:
Some people with prostate cancer have a rise in prostate-specific antigen (PSA). This can happen even after treatments like radiation and surgery. Androgen deprivation therapy (ADT) drugs and close monitoring are one standard way to treat this group of people. Another way is to monitor people and their PSA values over time. Researchers want to see if a combination of new drugs can help these people.
Objective:
To see if the combination treatment of PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec vaccinia), CV301, and MSB0011359C (M7824) can induce an anti-tumor impact in people with biochemically recurrent prostate cancer.
Eligibility:
People ages 18 and older with certain kinds of prostate cancer
Design:
Participants will be screened with
A sample of tissue that was already taken will be tested. This will confirm the diagnosis, stage, and disease status.
Some participants will have close monitoring with four monthly PSA checks.
All participants will get two study drugs as shots under the skin. They will get the third drug in a vein. They will get the drugs over at least 7 months. Their vital signs will be checked before they get the drugs and for up to 1 hour after.
Participants will have frequent study visits. They will have physical exams, urine and blood tests, and scans.
Participants will return to the clinic about 4 weeks after they stop taking the study drugs. They will have a medical history, physical exam, and blood tests. They may also have long-term follow-up visits.
Background:
Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy (i.e., biochemically recurrent [BCR] prostate cancer). The primary goal in these patients is to prevent morbidity from their cancer that results from disease progression and metastatic disease on conventional imaging.
ADT can lower the prostate-specific antigen (PSA) in these patients, but because of its substantial side effect profile and ambiguous long-term impact, it is generally deferred by most patients until there is a rapid escalation in their PSA.
Immunotherapy presents an alternative option for these patients that is especially attractive because it is not associated with substantial toxicity. Also, since immunotherapy can have lasting effects after treatment due to a sustained activated immune response, patients will not be required to take these treatments indefinitely to potentially benefit clinically.
Current and previous clinical trials have demonstrated that single agent immunotherapy can impact PSA in patients in this population.
The focus of this study is to determine if combination immunotherapy with Antigen direct immunotherapy antigen directed immunotherapy can initiate an immune response in the first 4 months that is then augmented by an immune checkpoint inhibitor in the following 3 months.
In addition to PSA responses (the primary metric in this population), safety, changes in immune responses, and PSA kinetics will also be evaluated.
Objectives:
Primary Objectives:
Safety Lead-In: To evaluate the safety and tolerability of combination immunotherapy in participants with castration-resistant prostate cancer
Biochemical Recurrence: To determine if the combination immunotherapy can induce a 30% decline in PSA in 28% of participants with biochemically recurrent prostate cancer.
Eligibility Criteria (for biochemical recurrence):
Histologically confirmed adenocarcinoma of the prostate
Participants with negative computed tomography (CT) Scan and Tc-99m Bone Scan
Participants with a PSA over 0.8 ng/ml for participants following radical prostatectomy or for participants following definitive radiation therapy: a rise in PSA of >= 2 ng/mL above the nadir
Participants with a PSA doubling time of 5-15 months
No history of active autoimmune disease or history of organ compromising autoimmune disease
Eastern Cooperative Oncology Group (ECOG) 0-1
Safety lead-in cohort will evaluate 6 participants with castration resistant prostate cancer
Design:
Three-arm, non-randomized study
Accrual goal is a total of 37 evaluable participants (6 in an initial safety cohort, 6 participants who received M7824 (MSB0011359C) as part of the initial investigation and 25 homogenously treated participants without M7824) to evaluate response
Participants from a previous study (NCT02649439) with nearly identical eligibility can serve as a contemporary control for secondary endpoints
Following the safety lead-in, all participants will be enrolled and may undergo a surveillance period during which up to 4 consecutive monthly PSA values will be captured by the labs.
After surveillance period, if applicable, participants will be treated with 2 Antigen direct immunotherapy's concurrently, Prostvac (rilimogene galvacirepvec/rilimogene glafolivec) and CV301, during months 1-4. For months 5-7, MSB0011359C [an anti-programmed Cell Death Ligand 1 (PD-L1) antibody (avelumab) with TGF(Beta)-Trap molecule] will be added to the regimen.
-Effective with amendment v7/29/2021, MSB0011359C (M7824) will no longer be given as part of the treatment combination for the Biochemical Recurrence cohort (Arms 3)
Participants will be monitored for on-treatment and post-treatment PSA, immune and imaging responses.
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.
Hepatic function eligibility parameters (within 16 days before starting therapy):
-- less than or equal to (ULN) (OR in participants with Gilbert's syndrome, a total bilirubin less than or equal to 3.0), (AST) and alanine aminotransferase (ALT) less than or equal to 1.5 times upper limit of normal.
Additional Inclusion Criteria Specific to Safety Lead-In Cohort
Progressive disease at study entry defined as one or more of the following criteria occurring in the setting of castrate levels of testosterone:
OR
Prostate-specific antigen (PSA) progression defined by sequence of rising values separated by >1 week (2 separate increasing values over a minimum of 2ng/ml (Prostate Cancer Working Group 2 (PCWG2) 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.
--Participants must agree to continuation of androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone agonist/antagonist or bilateral orchiectomy
Additional Inclusion Criteria Specific to Biochemical Recurrence Cohort
Biochemical progression defined as follows:
Hematological eligibility parameters (within 16 days before starting therapy):
EXCLUSION CRITERIA:
status due to:
Active diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease.
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.
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.
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.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
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.
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread 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.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
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.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
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.
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.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
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.
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.
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.
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.
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.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301+ MSB0011359C (M7824)
Biological: Antigen direct immunotherapy: PROSTVAC-V · Biological: Antigen direct immunotherapy: PROSTVAC-F · Drug: MSB0011359C (M7824) · Biological: Antigen direct immunotherapy: CV301 · Diagnostic Test: CT scan of chest · Diagnostic Test: CT scan of abdomen/pelvis · Diagnostic Test: MRI · Diagnostic Test: Bone scan
Surveillance followed by Prostvac ( rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301 then Prostvac + CV301 + MSB0011359C (M7824)
Biological: Antigen direct immunotherapy: PROSTVAC-V · Biological: Antigen direct immunotherapy: PROSTVAC-F · Drug: MSB0011359C (M7824) · Biological: Antigen direct immunotherapy: CV301 · Diagnostic Test: CT scan of chest · Diagnostic Test: CT scan of abdomen/pelvis · Diagnostic Test: MRI · Diagnostic Test: PSMA · Diagnostic Test: Bone scan
Surveillance as needed followed by Prostvac (rilimogene galvacirepvec/rilimogene glafolivec vaccinia) + CV301
Biological: Antigen direct immunotherapy: PROSTVAC-V · Biological: Antigen direct immunotherapy: PROSTVAC-F · Biological: Antigen direct immunotherapy: CV301 · Diagnostic Test: CT scan of chest · Diagnostic Test: CT scan of abdomen/pelvis · Diagnostic Test: MRI · Diagnostic Test: PSMA · Diagnostic Test: Bone scan
Recombinant vaccinia virus vector antigen direct immunotherapy of the genus Orthopoxvirus. Administered by subcutaneous injection.
Also known as: rilimogene galvacirepvec/rilimogene glafolivec vaccinia
Recombinant fowlpox virus vector Antigen direct immunotherapy of the genus Avipoxvirus. Administered by subcutaneous injection.
Also known as: rilimogene galvacirepvec/rilimogene glafolivec fowlpox
Fully human bifunctional fusion protein that combines immunoglobulin G1 (IgG1) anti-programmed death-ligand 1 (PD-L1) and Transforming growth factor, beta receptor II (TGFbetaRII) as a monoclonal antibody. Administered via intravenous (IV) infusion over 1 hour.
Also known as: M7824
Recombinant vaccinia virus Antigen direct immunotherapy of the genus Avipoxvirus. Administered subcutaneously.
Screening, prior to Antigen direct immunotherapy, end of study therapy, then every 6 months as long as participants remain in follow-up. And as clinically indicated after one year.
Also known as: Computed tomography
Screening, prior to Antigen direct immunotherapy, end of study therapy, then every 6 months as long as participants remain in follow-up. And as clinically indicated after one year.
Screening, prior to Antigen direct immunotherapy, end of study therapy, then every 6 months as long as participants remain in follow-up. And as clinically indicated after one year.
Also known as: Magnetic resonance imaging
Biochemical recurrence group only. Screening, prior to Antigen direct immunotherapy therapy, end of study therapy, then every 6 months as long as participants remain in follow-up. And as clinically indicated after one year.
Also known as: prostate-specific membrane antigen positron emission tomography scan
Screening, prior to Antigen direct immunotherapy, end of study therapy, then every 6 months as long as participants remain in follow-up. And as clinically indicated after one year.
Percentage of Participants With a Toxicity
Percentage of participants with a toxicity assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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: At the end of therapy (7 months)
Prostate Specific Antigen (PSA) Response
Proportion of evaluable participants who experience at least a 30% decline. PSA is a tumor marker in prostate cancer and elevated in participants with this stage of disease. Declines of 30% can be associated with favorable clinical outcomes.
Time frame: End of treatment (7 months)
Number of Participants With Related and/or Unrelated Grade 3 and Grade 4 Adverse Events.
Number of participants with related and/or unrelated Grade 3 and Grade 4 adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Reporting the grade of adverse events noted in each participant and reporting the fraction with grade 3 and grade 4 adverse events.
Time frame: 6 weeks
Number of Evaluable Participants With Biochemical Recurrence (BCR) With a 20% Change in PSA Doubling Time
PSA Doubling Time (DT) is the time interval (measured in months) it takes for PSA levels to double. PSA DT was calculated using the Memorial Sloan Kettering online PSA Doubling Time calculator. A long PSA DT suggests more indolent disease based on published data. PSA doubling time has been associated with better clinical outcomes in BCR. Note that PSA DT is calculated on a per participant basis and thus will be presented as number of evaluable participants with a change in PSA DT. A change in 20% would be considered meaningful and not due to lab variations. Thus, the data for this outcome is presented as number of evaluable participants experiencing a 20% change in PSA DT.
Time frame: End of treatment after 7 months
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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 was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 32 weeks.
| Milestone | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy |
|---|---|---|---|
| Started | 6 | 0 | 0 |
| Completed | 6 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy |
|---|---|---|---|
| Started | 0 | 8 | 0 |
| Completed | 0 | 2 | 0 |
| Not completed | 0 | 6 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 |
| Withdrew: Adverse event | 0 | 2 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: Participant came off study for intercurrent medical illness. | 0 | 1 | 0 |
| Milestone | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy |
|---|---|---|---|
| Started | 0 | 0 | 26 |
| Completed | 0 | 0 | 24 |
| Not completed | 0 | 0 | 2 |
| Withdrew: Progressive disease | 0 | 0 | 1 |
| Withdrew: An unrelated lymphoma diagnosis requiring therapy | 0 | 0 | 1 |
Percentage of participants with a toxicity assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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.
| Percentage of participants | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy |
|---|---|---|---|
| Percentage of Participants With a Toxicity | 6 | 7 | 24 |
Proportion of evaluable participants who experience at least a 30% decline. PSA is a tumor marker in prostate cancer and elevated in participants with this stage of disease. Declines of 30% can be associated with favorable clinical outcomes.
| Proportion of participants | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy |
|---|---|---|---|
| Prostate Specific Antigen (PSA) Response | 0 | 0 | 0 |
Number of participants with related and/or unrelated Grade 3 and Grade 4 adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Reporting the grade of adverse events noted in each participant and reporting the fraction with grade 3 and grade 4 adverse events.
| Participants | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy |
|---|---|---|---|
| Grade 3 Related | 1 | 1 | 0 |
| Grade 4 Related | 0 | 1 | 0 |
| Grade 3 Unrelated | 1 | 2 | 3 |
| Grade 4 Unrelated | 0 | 0 | 0 |
PSA Doubling Time (DT) is the time interval (measured in months) it takes for PSA levels to double. PSA DT was calculated using the Memorial Sloan Kettering online PSA Doubling Time calculator. A long PSA DT suggests more indolent disease based on published data. PSA doubling time has been associated with better clinical outcomes in BCR. Note that PSA DT is calculated on a per participant basis and thus will be presented as number of evaluable participants with a change in PSA DT. A change in 20% would be considered meaningful and not due to lab variations. Thus, the data for this outcome is presented as number of evaluable participants experiencing a 20% change in PSA DT.
| Participants | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy |
|---|---|---|
| Participants evaluable for change in PSA Doubling Time | 2 | 23 |
| Participants with greater than 20% increase in PSA Doubling Time | 1 | 11 |
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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 | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy |
|---|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 6 | 7 | 25 |
Collected over All-Cause Mortality was monitored/assessed for an average of 32 days. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, an average of 32 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 0/6 (0%) | 1/6 (16.7%) | 6/6 (100%) |
| 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 0/8 (0%) | 3/8 (37.5%) | 7/8 (87.5%) |
| 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy | 0/26 (0%) | 2/26 (7.7%) | 25/26 (96.2%) |
| Event | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy |
|---|---|---|---|
| Cardiac disorders - Other, specify: Accelerated Junctional RhythmCardiac disorders | 1/6 | 0/8 | 0/26 |
| CPK increasedInvestigations | 0/6 | 1/8 | 0/26 |
| DiarrheaGastrointestinal disorders | 0/6 | 1/8 | 0/26 |
| Infections and infestations - Other, specify: CovidInfections and infestations | 0/6 | 1/8 | 0/26 |
| Muscle weakness lower limbMusculoskeletal and connective tissue disorders | 0/6 | 1/8 | 0/26 |
| MyocarditisCardiac disorders | 0/6 | 1/8 | 0/26 |
| MyositisMusculoskeletal and connective tissue disorders | 0/6 | 1/8 | 0/26 |
| StrokeNervous system disorders | 0/6 | 1/8 | 0/26 |
| Abdominal painGastrointestinal disorders | 0/6 | 0/8 | 1/26 |
| Gastrointestinal disorders - Other, specify: DiverticulitisGastrointestinal disorders | 0/6 | 0/8 | 1/26 |
| Event | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy |
|---|---|---|---|
| Injection site reactionGeneral disorders | 6/6 | 7/8 | 24/26 |
| PainGeneral disorders | 4/6 | 0/8 | 3/26 |
| Flu like symptomsGeneral disorders | 3/6 | 5/8 | 14/26 |
| FatigueGeneral disorders | 2/6 | 3/8 | 14/26 |
| Lipase increasedInvestigations | 1/6 | 3/8 | 0/26 |
| Dry skinSkin and subcutaneous tissue disorders | 2/6 | 1/8 | 0/26 |
| HematuriaRenal and urinary disorders | 2/6 | 2/8 | 1/26 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 2/6 | 0/8 | 1/26 |
| Aspartate aminotransferase increasedInvestigations | 0/6 | 2/8 | 0/26 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/6 | 2/8 | 0/26 |
| Age, Categorical(Participants) | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 7 | 11 |
| >=65 years | 4 | 6 | 19 | 29 |
| Age, Continuous(years) | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy | Total |
|---|---|---|---|---|
| Mean | 64.5 ± 5.37 | 74.41 ± 8.38 | 69.22 ± 6.61 | 69.55 ± 7.29 |
| Sex: Female, Male(Participants) | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 6 | 8 | 26 | 40 |
| Ethnicity (NIH/OMB)(Participants) | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 2 | 2 |
| Not Hispanic or Latino | 5 | 8 | 24 | 37 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 3 | 5 |
| White | 5 | 7 | 22 | 34 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | 1/ Lead-In Cohort (Closed December 2018)/Arm 1/Combination Therapy [Closed December 2018] | 2/Biochemical Recurrence Cohort/Arm 1/Combination Therapy [Closed March 2021] | 2/Biochemical Recurrence Cohort/Arm2/Combo Therapy (Tx)+/Arm3/Combo Antigen Direct Immunotherapy | Total |
|---|---|---|---|---|
| United States | 6 | 8 | 26 | 40 |
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 Mar 2018 to primary completion in Jun 2024, 74 months.
Results were first posted in Jun 2025, 1 year after primary completion.
Of 610 non-industry phase 2 interventional studies under Prostatic Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 86. This study's 74 months is above that.
Counting every sponsor, half of 724 studies reached it within 53 months; a quarter within 34 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bintrafusp alfa
National Cancer Institute (NCI) →