Skip to content
Triangle logo TriangleGet started
← Germ Cell Tumor

NCT02721732 · 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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

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.

→

secondary · POSTED

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.

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.

→

secondary · POSTED

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.

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.

→

secondary · POSTED

ORR is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.

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.

→

secondary · POSTED

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.

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.

→

secondary · POSTED

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.

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-germ-cell-tumor
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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-germ-cell-tumor
    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