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NCT02837042 · STUDY IN CONTEXT

Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma

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

The response rate will be evaluated every 3 weeks using the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in addition to immune related criteria based on patterns of response.

Source null

→

secondary · POSTED

The duration of time from the start of treatment to the first documentation of tumor progression.

Since the trial stopped due to poor accrual, and more censored patients, the 95% CI for median PFS and OS could not be determined. We are reporting median values without CI.

→

secondary · POSTED

Length of subject survival after starting study treatment

Due to poor accrual, low sample size, and higher number of patients censored, the 95% CI for median OS and PFS could not be determined.

→

secondary · POSTED

Adverse events reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.

Source null

→

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-penile-cancer
nct id
NCT02837042
trial label
Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma
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
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-penile-cancer
    nct id
    NCT02837042
    outcome key
    om-0000
    source section id
    NCT02837042-om-0000
    source outcome index
    0
    endpoint
    Objective Tumor Response Rate
    endpoint definition
    The response rate will be evaluated every 3 weeks using the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) in addition to immune related criteria based on patterns of response.
    time origin
    Baseline up to two years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-penile-cancer
    nct id
    NCT02837042
    outcome key
    om-0001
    source section id
    NCT02837042-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    The duration of time from the start of treatment to the first documentation of tumor progression.
    time origin
    Baseline up to two years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Since the trial stopped due to poor accrual, and more censored patients, the 95% CI for median PFS and OS could not be determined. We are reporting median values without CI.
    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-penile-cancer
    nct id
    NCT02837042
    outcome key
    om-0002
    source section id
    NCT02837042-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Length of subject survival after starting study treatment
    time origin
    From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Due to poor accrual, low sample size, and higher number of patients censored, the 95% CI for median OS and PFS could not be determined.
    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-penile-cancer
    nct id
    NCT02837042
    outcome key
    om-0003
    source section id
    NCT02837042-om-0003
    source outcome index
    3
    endpoint
    Number of Patients With Adverse Events
    endpoint definition
    Adverse events reporting will be graded following the National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0.
    time origin
    Baseline up to two years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-penile-cancer
    nct id
    NCT02837042
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pembrolizumab 200 mg
    regimen
    Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02837042-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-penile-cancer
    nct id
    NCT02837042
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pembrolizumab 200 mg
    regimen
    Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02837042-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-penile-cancer
    nct id
    NCT02837042
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Pembrolizumab 200 mg
    regimen
    Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02837042-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-penile-cancer
    nct id
    NCT02837042
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Pembrolizumab 200 mg
    regimen
    Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02837042-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-penile-cancer
    nct id
    NCT02837042
    harm key
    EG000
    source section id
    NCT02837042-ae
    event group key
    EG000
    event group label
    Pembrolizumab 200 mg
    serious affected
    2
    serious at risk
    6
    other affected
    2
    other at risk
    6
    frequency threshold
    5
    collection period
    From baseline through one year after the end of the study, up to 2 years.
    event definition
    The study was closed prematurely due to poor accrual and substantial loss to follow-up of patients.
    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