TriangleNCT02721732 · STUDY IN CONTEXT
Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic
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
Non-progression rate (NPR) at 27 weeks was defined as the percentage of efficacy evaluable patients who were alive and progression-free at 27 weeks as assessed by irRECIST Progression is defined using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST), as an increase ≥ 20% (minimum 5 mm) in total measured tumor burden compared with nadir or progression of non-target lesions or new lesion
Immune-related ORR is defined as the percentage of patients achieving a irCR or irPR based on irRECIST criteria. PD-L1 positivity was defined as Combined Positive Score ≥1. Evaluated objective response in PD-L1 positive patients Per irRECIST: Immune-related (ir) Complete Response (irCR), disappearance of all target and non-target lesions, nodal short axis diameter \<10 mm, no new lesions; irPartial Response (irPR), decrease of ≥30% in tumor burden relative to baseline, non-unequivocal progression of non-target lesions, no new lesions.
Per protocol, the number and percentage of patients with any treatment-related AE was summarized for all study patients combined. Patients were monitored for AE from the first day of administration of study medication through 30 days following last dose. Each AE (as defined by NCI CTCAE v4.03) was counted only once for a given subject. In the event a patient experienced repeated episodes of the same AE, then the event with the highest severity and/or strongest causal relationship to study treatment was used for purposes of tabulations.
ORR is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.
CBR is defined as the percentage of patients achieving a CR or PR, or stable disease (SD) ≥4 months based on RECIST 1.1 criteria.
PFS was defined as the time from administration of the first dose to the first documented disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.
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-adrenocortical-carcinoma
- nct id
- NCT02721732
- trial label
- Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic
- 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- source section id
- NCT02721732-om-0000
- source outcome index
- 0
- endpoint
- Non-progression Rate (NPR) at 27 Weeks by irRECIST
- endpoint definition
- Non-progression rate (NPR) at 27 weeks was defined as the percentage of efficacy evaluable patients who were alive and progression-free at 27 weeks as assessed by irRECIST Progression is defined using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST), as an increase ≥ 20% (minimum 5 mm) in total measured tumor burden compared with nadir or progression of non-target lesions or new lesion
- time origin
- At 27 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who have received at least 1 dose of study medication with at least 1on-study tumor assessment were included in the analysis. If a patient discontinued before the first radiological assessment due to progression, they were included in the analysis. If the patient discontinued before 27 weeks due to reasons other than progression or death, they were considered non evaluable for this endpoint. One patient enrolled in the ACC cohort was excluded due to change in diagnosis.
- 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-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0001
- source section id
- NCT02721732-om-0001
- source outcome index
- 1
- endpoint
- Evaluation of Tumor Size (Objective Response by irRECIST) to PD-L1 Status (CPS ≥1)
- endpoint definition
- Immune-related ORR is defined as the percentage of patients achieving a irCR or irPR based on irRECIST criteria. PD-L1 positivity was defined as Combined Positive Score ≥1. Evaluated objective response in PD-L1 positive patients Per irRECIST: Immune-related (ir) Complete Response (irCR), disappearance of all target and non-target lesions, nodal short axis diameter \<10 mm, no new lesions; irPartial Response (irPR), decrease of ≥30% in tumor burden relative to baseline, non-unequivocal progression of non-target lesions, no new lesions.
- time origin
- Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- PD-L1 expression on tumor and mononuclear inflammatory cells in tumor nests were assessed on samples obtained prior to treatment. Patients with PD-L1 positive disease (CPS ≥1) were evaluated for objective response.
- 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-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0002
- source section id
- NCT02721732-om-0002
- source outcome index
- 2
- endpoint
- Number of Patients Who Experienced Treatment-related Adverse Event (TRAE)
- endpoint definition
- Per protocol, the number and percentage of patients with any treatment-related AE was summarized for all study patients combined. Patients were monitored for AE from the first day of administration of study medication through 30 days following last dose. Each AE (as defined by NCI CTCAE v4.03) was counted only once for a given subject. In the event a patient experienced repeated episodes of the same AE, then the event with the highest severity and/or strongest causal relationship to study treatment was used for purposes of tabulations.
- time origin
- First day of administration of study medication through 30 days following last dose, an average of 4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- It was a pre-specified objective. All patients who have received at least 1 dose of study medication were included in the safety analysis. A total of 157 patients were treated on this study. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis following histological assessment of the surgical specimen.
- 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-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0003
- source section id
- NCT02721732-om-0003
- source outcome index
- 3
- endpoint
- Objective Response Rate (ORR) Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- endpoint definition
- ORR is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.
- time origin
- Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who have received at least 1 dose of study medication with at least one adequate on-study tumor assessment were included in the efficacy analysis. If a patient discontinued the study before the first radiological assessment due to progression of disease, either radiological or clinical, they were considered evaluable and were included in the efficacy analysis. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis.
- 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-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0004
- source section id
- NCT02721732-om-0004
- source outcome index
- 4
- endpoint
- Clinical Benefit Rate (CBR) Using RECIST v1.1
- endpoint definition
- CBR is defined as the percentage of patients achieving a CR or PR, or stable disease (SD) ≥4 months based on RECIST 1.1 criteria.
- time origin
- Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who have received at least 1 dose of study medication with at least one adequate on-study tumor assessment were included in the efficacy analysis. If a patient discontinued the study before the first radiological assessment due to progression of disease, either radiological or clinical, they were considered evaluable and were included in the efficacy analysis. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis.
- 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-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0005
- source section id
- NCT02721732-om-0005
- source outcome index
- 5
- endpoint
- Progression-free Survival (PFS) Using RECIST v1.1
- endpoint definition
- PFS was defined as the time from administration of the first dose to the first documented disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.
- time origin
- Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who have received at least 1 dose of study medication with at least one adequate on-study tumor assessment were included in the efficacy analysis. If a patient discontinued the study before the first radiological assessment due to progression of disease, either radiological or clinical, they were considered evaluable and were included in the efficacy analysis. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis.
- 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-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cohort 1: Squamous Cell Carcinoma of the Skin
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cohort 2: Small Cell Malignancies of Nonpulmonary Origin
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Cohort 3: Adrenocortical Carcinoma
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Cohort 4: Medullary Renal Cell Carcinoma
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Cohort 5: Carcinoma of Unknown Primary
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Cohort 6: Penile Carcinoma
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Cohort 7: Vascular Sarcoma
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- arm key
- OG007
- arm label
- Cohort 8: Germ Cell Tumor
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0000#groups/OG007
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- arm key
- OG008
- arm label
- Cohort 9: Paraganglioma-pheochromocytoma
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0000#groups/OG008
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0000
- arm key
- OG009
- arm label
- Cohort 10: Other Rare Tumor Histologies
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0000#groups/OG009
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Cohort 1: Squamous Cell Carcinoma of the Skin
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cohort 2: Small Cell Malignancies of Nonpulmonary Origin
- regimen
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02721732-om-0001#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adrenocortical-carcinoma
- nct id
- NCT02721732
- harm key
- EG000
- source section id
- NCT02721732-ae
- event group key
- EG000
- event group label
- Participants With Advanced Rare Cancer
- serious affected
- 72
- serious at risk
- 156
- other affected
- 84
- other at risk
- 156
- frequency threshold
- 0
- collection period
- First day of administration of study medication through 30 days following last dose.
- event definition
- All participants received the same intervention. Therefore, per protocol, all cause-mortality, SAEs and other AEs are reported for all study patients combined.
- 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