Trial · NCT03427411
M7824 in Subjects With HPV Associated Malignancies
NCT03427411, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2022-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. M7824 in Subjects With HPV Associated Malignancies. Trials, record NCT03427411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03427411
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- M7824 in Subjects With HPV Associated Malignancies
- NCT number
- NCT03427411
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Human Papilloma Virus, Cervical Cancer, Oropharyngeal Cancer, Anal Cancer, Vaginal or Penile Cancer
- Interventions
- M7824
- First posted
- 2018-02-09
- Last updated
- 2023-03-28
- Results first posted
- 2022-02-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response | Every six weeks for up to one year | 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. |
| Secondary | Progression-free Survival Time (PFS) | Time from the date of first treatment to the date of disease progression or death, up to 12 months | 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. |
| Secondary | 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 | 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). |
| Secondary | Overall Survival (OS) | Time from the date of first treatment to the date of death, up to 3 years. | OS is defined as the time from the date of first treatment to the date of death and was measured by Kaplan-Meier analysis. |
| Secondary | Number of Participants With Serious Grade ≥3 Adverse Events Considered Related to Study Treatment of M7824 | 28 days after treatment | 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. |
| Secondary | 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 | median of 2 years | 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). |
| Secondary | Percentage of Participants That Were Hospitalized Because of Adverse Events Attributed to Disease Progression | Up to 30 days from last treatment | 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. |
| Secondary | Duration of Response (Complete Response or Partial Response) | 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 | 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. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 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. | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response | Every six weeks for up to one year | 1/30 participants was not evaluable in the naïve group because the participant was determined to be HPV negative. 1/27 was not evaluable in the refractory group because one participant was a screen failure and was not treated. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival Time (PFS) | Time from the date of first treatment to the date of disease progression or death, up to 12 months | 1/30 participants was not evaluable in the naïve group because they were found to be HPV negative and 1/27 was not evaluable in the refractory group because one participant was a screen failure. | Months | MEDIAN |
| SECONDARY | 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 | 6 months | 1/30 participants was not evaluable in the naïve group because they were determined to be HPV negative, and 1/27 was not evaluable in the refractory group because one participant was a screen failure. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Time from the date of first treatment to the date of death, up to 3 years. | 1/30 participants was not evaluable in the naïve group because the patient was determined to be HPV negative, and 1/27 was not evaluable in the refractory group because one participant was a screen failure and was not treated. | Months | MEDIAN |
| SECONDARY | Number of Participants With Serious Grade ≥3 Adverse Events Considered Related to Study Treatment of M7824 | 28 days after treatment | One participant enrolled in the refractory group was a screen failure and was not treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | median of 2 years | Only cohorts 1 and 2 was evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants That Were Hospitalized Because of Adverse Events Attributed to Disease Progression | Up to 30 days from last treatment | One participant enrolled in the refractory group was a screen failure and was not treated. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (Complete Response or Partial Response) | 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 | Months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 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. | One enrolled participant was a screen failure and was not treated. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 31 | 95% Confidence Interval 15.3 to 50.8 | percentage of participants | |
| Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 7.7 | 95% Confidence Interval 0.9 to 25.1 | percentage of participants | |
| Progression-free Survival Time (PFS) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 3.5 | 95% Confidence Interval 1.5 to 7.4 | Months | |
| Progression-free Survival Time (PFS) | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 1.4 | 95% Confidence Interval 0.0 to 9.2 | 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 | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 62.1 | 95% Confidence Interval 42.3 to 79.3 | percentage of participants | |
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 | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 19.2 | 95% Confidence Interval 6.6 to 39.4 | percentage of participants | |
| Overall Survival (OS) | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 19.2 | 95% Confidence Interval 9.7 to NA | Months | |
| Overall Survival (OS) | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 4.4 | 95% Confidence Interval 2.7 to 13.2 | Months | |
| Number of Participants With Serious Grade ≥3 Adverse Events Considered Related to Study Treatment of M7824 | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 6 | Participants | ||
| Number of Participants With Serious Grade ≥3 Adverse Events Considered Related to Study Treatment of M7824 | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 4 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 30 | |
| Overall Study | STARTED | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 27 | |
| Overall Study | COMPLETED | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 30 | |
| Overall Study | COMPLETED | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 26 | |
| Overall Study | NOT COMPLETED | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 0 | |
| Overall Study | NOT COMPLETED | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 1 |
Source ClinicalTrials.gov
Adverse events630
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 8 | 30 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 7 | 26 | 10 |
| other | Adrenal insufficiency | Endocrine disorders | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 2 | 30 | 2 |
| other | Adrenal insufficiency | Endocrine disorders | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 0 | 26 | 0 |
| other | Agitation | Psychiatric disorders | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 0 | 30 | 0 |
| other | Agitation | Psychiatric disorders | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 2 | 26 | 2 |
| other | Alanine aminotransferase increased | Investigations | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 4 | 30 | 5 |
| other | Alanine aminotransferase increased | Investigations | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 4 | 26 | 4 |
| other | Alkaline phosphatase increased | Investigations | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 1 | 30 | 1 |
| other | Alkaline phosphatase increased | Investigations | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 4 | 26 | 4 |
1 to 10 of 630Source ClinicalTrials.gov
See all 630 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 18 | 30 |
| Total, all-cause mortality | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 22 | 26 |
| Total, other adverse events | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 30 | 30 |
| Total, other adverse events | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 26 | 26 |
| Total, serious adverse events | Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 19 | 30 |
| Total, serious adverse events | Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks | 21 | 26 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks vs 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) | Trial comparisons |
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks vs 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 | Trial comparisons |
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks vs Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks: deaths from any cause | Trial comparisons |
Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks vs Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03427411
GET https://conductscience.org/api/trials/v1/NCT03427411/results?page=2