TriangleNCT03427411 · STUDY IN CONTEXT
M7824 in Subjects With HPV Associated Malignancies
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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).
OS is defined as the time from the date of first treatment to the date of death and was measured by Kaplan-Meier analysis.
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.
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).
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- trial label
- M7824 in Subjects With HPV Associated Malignancies
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0000
- source section id
- NCT03427411-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response
- endpoint definition
- 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 origin
- Every six weeks for up to one year
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0001
- source section id
- NCT03427411-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival Time (PFS)
- endpoint definition
- 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 origin
- Time from the date of first treatment to the date of disease progression or death, up to 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0002
- source section id
- NCT03427411-om-0002
- source outcome index
- 2
- endpoint
- 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
- endpoint definition
- 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 origin
- 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0003
- source section id
- NCT03427411-om-0003
- source outcome index
- 3
- endpoint
- Overall Survival (OS)
- endpoint definition
- 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 origin
- Time from the date of first treatment to the date of death, up to 3 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0004
- source section id
- NCT03427411-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Serious Grade ≥3 Adverse Events Considered Related to Study Treatment of M7824
- endpoint definition
- 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 origin
- 28 days after treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One participant enrolled in the refractory group was a screen failure and was not treated.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0005
- source section id
- NCT03427411-om-0005
- source outcome index
- 5
- endpoint
- 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
- endpoint definition
- 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 origin
- median of 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Only cohorts 1 and 2 was evaluable for this outcome measure.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with human papillomavirus (HPV) associated cancers refractory to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- regimen
- Participants with anal cancer, non-neuroendocrine cervical cancer, P16 positive (P16+) oropharyngeal cancers, and other rare HPV associated tumors (e.g., squamous cell rectal, vulvar, vaginal, penile cancer, neuroendocrine cervical) naïve to checkpoint inhibition treated with M7824 at a flat dose of 1,200 mg intravenous (IV) once every 2 weeks until confirmed progressive disease, death, unacceptable toxicity, or study withdrawal.
- analyzed count
- 29
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03427411-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- harm key
- EG000
- source section id
- NCT03427411-ae
- event group key
- EG000
- event group label
- Participants Naïve to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- serious affected
- 19
- serious at risk
- 30
- other affected
- 30
- other at risk
- 30
- frequency threshold
- 0
- collection period
- 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.
- event definition
- One participant enrolled in the refractory group was a screen failure and was not treated.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-penile-cancer
- nct id
- NCT03427411
- harm key
- EG001
- source section id
- NCT03427411-ae
- event group key
- EG001
- event group label
- Participants Refractory to Checkpoint Inhibition - M7824 1,200 mg Intravenous Once Every 2 Weeks
- serious affected
- 21
- serious at risk
- 26
- other affected
- 26
- other at risk
- 26
- frequency threshold
- 0
- collection period
- 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.
- event definition
- One participant enrolled in the refractory group was a screen failure and was not treated.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice