A Phase 2 interventional study of M7824 in Human Papilloma Virus, Cervical Cancer and Oropharyngeal Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
Among 70 studies in Uterine Cervical Neoplasms by National Cancer Institute (NCI) — 3 open to participants now, 12 under way, 2 of them phase 3. Uterine Cervical Neoplasms · National Cancer Institute (NCI).
Among the 70 studies in Uterine Cervical Neoplasms by National Cancer Institute (NCI), this one is the 20th largest by enrollment of the 57 interventional ones that give a count, is one of 2 that started in 2018, is one of 26 in phase 2, and was the 57th registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
Browse Uterine Cervical Neoplasms studies →3 of the 70 studies in Uterine Cervical 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 25+ · Women only · Healthy volunteers
National Cancer Institute (NCI) · Sites in United States, Puerto Rico
Ages 18+ · Women only
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
By country, each count listing its studies:
Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.
This study: 18 Years and older · 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.
70 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 27 · Phase 2 36 · Phase 3 4
First in 1995; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 57 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Median enrollment 41 across the 57 interventional studies, 5,257 across the 8 observational. Of the 55 that completed or were terminated, 29 (53%) 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.
6 of the studies in Uterine Cervical 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 |
|---|---|
| NCT00867464National Cancer Institute (NCI)Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls | 2026-12-23 |
| NCT06611540National Cancer Institute (NCI)Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03) | 2026-12-30 |
| NCT06611553National Cancer Institute (NCI)Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02) | 2026-12-30 |
| NCT06498661National Cancer Institute (NCI)Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01) | 2026-12-30 |
| NCT07281430National Cancer Institute (NCI)Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04) | 2026-12-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 70 studies in Uterine Cervical 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:
In the United States, each year there are more than 30,000 cases of human papillomavirus (HPV) associated cancers. Some of these cancers are often incurable and are not improved by standard therapies. Researchers want to see if a new drug M7824, which targets and blocks a pathway that prevents the immune system from effectively fighting the cancer can shrink tumors in people with some HPV cancers.
Objectives:
To see if the drug M7824 causes tumors to shrink.
Eligibility:
Adults age 18 and older who have a cancer associated with HPV infection.
Design:
Participants will be screened with medical history and physical exam. They will review their symptoms and how they perform normal activities. They will have body scans. They will give blood and urine samples. They will have a sample of their tumor tissue taken if one is not available.
Participants will have an electrocardiogram to evaluate their heart. Then they will get the study drug through a thin tube in an arm vein.
Participants will get the drug every 2 weeks for 26 times (1 year). This is 1 course.
After the course, participants will be monitored but will not take the study drug. If their condition gets worse, they will start another course with the drug. This process can be repeated as many times as needed.
Treatment will stop if the participant has bad side effects or the drug stops working.
Throughout the study, participants will repeat some or all the screening tests.
After participants stop taking the drug, they will have a follow-up visit and repeat some screening tests. They will get periodic follow-up phone calls.
Background:
Metastatic or refractory/recurrent human papillomavirus (HPV) associated malignancies (cervical, anal, oropharyngeal cancers etc.) are often incurable and poorly palliated by standard therapies.
Notably, the P16+ head and neck cancer patient with unconfirmed PR, anal cancer patient with durable PR and cervical cancer patient with durable CR all have HPV+ disease.
Objective:
-To determine the objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in subjects with recurrent or metastatic HPV associated malignancies.
Eligibility:
associated malignancies including:
Other locally advanced or metastatic solid tumors (e.g. lung, esophagus) that are known HPV+
Design:
-This is a Phase II trial of M7824 in patients with recurrent or metastatic HPV associated
malignancies.
There will be six cohorts: (1) Patients with anal cancer whose disease is naive to checkpoint inhibition, (2) Patients with non-neuroendocrine cervical cancer naive to checkpoint inhibition,
(3) Patients with P16+ oropharyngeal cancers naive to checkpoint inhibition, and (4) Patients with other rare HPV associated tumors (e.g. squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naive to checkpoint inhibition, (5) Patients with any HPV associated cancers whose disease is refractory to checkpoint inhibition. Patients who are determined to be HPV negative after enrolling will be taken off of their previously assigned cohort and reassigned to cohort 6 and their slot on their previously assigned cohort will be replaced.
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.
Subjects with or histologically confirmed locally advanced or human papillomavirus (HPV) associated including:
Adequate hematologic function at screening, as follows:
Adequate renal and hepatic function at screening, as follows:
treatment of the mother with M7824, breastfeeding should be discontinued if the mother is treated with M7824.
Active disease that might deteriorate when receiving an immunostimulatory agent with exception of:
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.
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.
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.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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 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 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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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 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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
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.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
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.
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.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
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.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks
Drug: M7824
Flat dose of 1,200 mg of M7824 intravenous (IV) once every 2 weeks
Also known as: MSB0011359C
Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response
The percentage of participants that achieved an objective confirmed complete or partial overall tumor response was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Every six weeks for up to one year
Progression-free Survival Time (PFS)
PFS is defined as the time from the date of first treatment to the date of disease progression or death. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions.
Time frame: Time from the date of first treatment to the date of disease progression or death, up to 12 months
Percentage of Participants With Disease Control Who Achieved a Complete Response, Partial Response and Stable Disease Defined by the Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1 Lasting at Least 6 Months
The percentage of participants with disease control who achieved a complete response, partial response and stable disease lasting at least 6 months was measured by the response evaluation criteria in solid tumors (RECIST)version 1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) (at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions).
Time frame: 6 months
Overall Survival (OS)
OS is defined as the time from the date of first treatment to the date of death and was measured by Kaplan-Meier analysis.
Time frame: Time from the date of first treatment to the date of death, up to 3 years.
Number of Participants With Serious Grade ≥3 Adverse Events Considered Related to Study Treatment of M7824
Adverse events were assessed by the Common Terminology Criteria for Adverse Events version 5.0. 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. Grade 1 is mild. Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
Time frame: 28 days after treatment
Number of Checkpoint Inhibitor Naive Participants With Response Based on Adequate Similarity (Defined as P-value > 0.2 With Fisher's Exact Test) of Results in Cohorts 1 and 2
Response based on adequate similarity defined as P-value \> 0.2 with Fisher's exact test of results in cohorts 1 and 2 was compared with a two-sided Fishers exact test, and response was measured by the response evaluation criteria in solid tumors (RECIST)version 1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Time frame: median of 2 years
Percentage of Participants That Were Hospitalized Because of Adverse Events Attributed to Disease Progression
Adverse events were 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. Disease progression is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 30 days from last treatment
Duration of Response (Complete Response or Partial Response)
Duration of response is defined as the time from complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions.
Time frame: Time from complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented, up to 12 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: Date treatment consent signed to date off study, approximately 42 months and 28 days for the naïve group, and 40 months and 16 days for the refractory group.
| Milestone | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| Started | 30 | 27 |
| Completed | 30 | 26 |
| Not completed | 0 | 1 |
| Withdrew: Screen failure - platelets too low | 0 | 1 |
The percentage of participants that achieved an objective confirmed complete or partial overall tumor response was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| percentage of participants | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response | 31 (15.3 to 50.8) | 7.7 (0.9 to 25.1) |
PFS is defined as the time from the date of first treatment to the date of disease progression or death. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is defined as at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions.
| Months | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| Progression-free Survival Time (PFS) | 3.5 (1.5 to 7.4) | 1.4 (0.0 to 9.2) |
The percentage of participants with disease control who achieved a complete response, partial response and stable disease lasting at least 6 months was measured by the response evaluation criteria in solid tumors (RECIST)version 1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) (at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions).
| percentage of participants | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| Percentage of Participants With Disease Control Who Achieved a Complete Response, Partial Response and Stable Disease Defined by the Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1 Lasting at Least 6 Months | 62.1 (42.3 to 79.3) | 19.2 (6.6 to 39.4) |
OS is defined as the time from the date of first treatment to the date of death and was measured by Kaplan-Meier analysis.
| Months | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| Overall Survival (OS) | 19.2 (9.7 to NA) | 4.4 (2.7 to 13.2) |
Adverse events were assessed by the Common Terminology Criteria for Adverse Events version 5.0. 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. Grade 1 is mild. Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
| Participants | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| Number of Participants With Serious Grade ≥3 Adverse Events Considered Related to Study Treatment of M7824 | 6 | 4 |
Response based on adequate similarity defined as P-value \> 0.2 with Fisher's exact test of results in cohorts 1 and 2 was compared with a two-sided Fishers exact test, and response was measured by the response evaluation criteria in solid tumors (RECIST)version 1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
| Participants | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|
| Complete Response | 2 |
| Partial Response | 7 |
| Progressive Disease | 10 |
| Stable Disease | 9 |
| Not Evaluable | 1 |
Adverse events were 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. Disease progression is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
| percentage of participants | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| Percentage of Participants That Were Hospitalized Because of Adverse Events Attributed to Disease Progression | 37.9 | 69.2 |
Duration of response is defined as the time from complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease (PD) is objectively documented. Response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions, or appearance of one or more new lesions.
| Months | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| Duration of Response (Complete Response or Partial Response) | NA (8.3 to NA) | 4.0 (2.8 to NA) |
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 | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 30 | 26 |
Collected over Date treatment consent signed to date off study, approximately 42 months and 28 days for the naïve group, and 40 months and 16 days for the refractory group.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 18/30 (60%) | 19/30 (63.3%) | 30/30 (100%) |
| Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 22/26 (84.6%) | 21/26 (80.8%) | 26/26 (100%) |
| Event | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 3/30 | 6/26 |
| Disease progressionGeneral disorders | 0/30 | 5/26 |
| Abdominal painGastrointestinal disorders | 3/30 | 3/26 |
| FatigueGeneral disorders | 0/30 | 3/26 |
| HematuriaRenal and urinary disorders | 0/30 | 3/26 |
| NauseaGastrointestinal disorders | 3/30 | 1/26 |
| VomitingGastrointestinal disorders | 3/30 | 1/26 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/30 | 2/26 |
| FeverGeneral disorders | 1/30 | 2/26 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, SpecifyNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/30 | 2/26 |
| Event | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 19/30 | 19/26 |
| FatigueGeneral disorders | 18/30 | 11/26 |
| AnorexiaMetabolism and nutrition disorders | 10/30 | 12/26 |
| Lymphocyte count decreasedInvestigations | 11/30 | 12/26 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 11/30 | 11/26 |
| NauseaGastrointestinal disorders | 11/30 | 8/26 |
| ConstipationGastrointestinal disorders | 10/30 | 6/26 |
| Rash acneiformSkin and subcutaneous tissue disorders | 10/30 | 6/26 |
| HypoalbuminemiaMetabolism and nutrition disorders | 7/30 | 8/26 |
| PruritusSkin and subcutaneous tissue disorders | 8/30 | 8/26 |
One participant enrolled in the refractory group was a screen failure and was not treated. However, collected baseline data is shown here.
| Age, Categorical(Participants) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 18 | 43 |
| >=65 years | 5 | 9 | 14 |
| Age, Continuous(years) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Total |
|---|---|---|---|
| Mean | 53.48 ± 13.49 | 58.73 ± 11.94 | 55.96 ± 12.94 |
| Sex: Female, Male(Participants) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Total |
|---|---|---|---|
| Female | 25 | 11 | 36 |
| Male | 5 | 16 | 21 |
| Ethnicity (NIH/OMB)(Participants) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 28 | 25 | 53 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 23 | 26 | 49 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Total |
|---|---|---|---|
| United States | 30 | 27 | 57 |
| Site of Primary Tumor(Participants) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | Total |
|---|---|---|---|
| Anus | 4 | 6 | 10 |
| Cervix | 15 | 6 | 21 |
| Head-face or neck - Not Otherwise Specified | 1 | 1 | 2 |
| Head/Neck | 1 | 2 | 3 |
| Hypopharynx | 0 | 1 | 1 |
| Oropharynx | 0 | 1 | 1 |
| Rectum | 3 | 1 | 4 |
| Tongue | 0 | 1 | 1 |
| Tongue, Base of Tongue | 1 | 3 | 4 |
| Tonsil | 1 | 5 | 6 |
| Vagina | 1 | 0 | 1 |
| Vulva | 2 | 0 | 2 |
| Penile | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All 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 the 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 Feb 2018 to primary completion in Feb 2021, 35 months.
Results were first posted in Feb 2022, 1 year after primary completion.
Of 154 non-industry phase 2 interventional studies under Uterine Cervical Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 99. This study's 35 months is below that.
Counting every sponsor, half of 204 studies reached it within 42 months; a quarter within 29 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. 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) →