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NCT02721732 · OUTCOME

Evaluation of Tumor Size (Objective Response by irRECIST) to PD-L1 Status (CPS ≥1)

Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic · Source last updated 2026-07-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
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.

What was measured

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.

Analysis population: 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.

Groups in this outcome

Cohort 1: Squamous Cell Carcinoma of the Skin

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

Cohort 2: Small Cell Malignancies of Nonpulmonary Origin

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

Cohort 3: Adrenocortical Carcinoma

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

Cohort 4: Medullary Renal Cell Carcinoma

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

Cohort 5: Carcinoma of Unknown Primary

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

Cohort 6: Penile Carcinoma

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

Cohort 7: Vascular Sarcoma

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

Cohort 8: Germ Cell Tumor

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

Cohort 9: Paraganglioma-pheochromocytoma

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

Cohort 10: Other Rare Tumor Histologies

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1: Squamous Cell Carcinoma of the Skin14
Cohort 2: Small Cell Malignancies of Nonpulmonary Origin6
Cohort 3: Adrenocortical Carcinoma2
Cohort 4: Medullary Renal Cell Carcinoma4
Cohort 5: Carcinoma of Unknown Primary16
Cohort 6: Penile Carcinoma2
Cohort 7: Vascular Sarcoma6
Cohort 8: Germ Cell Tumor3
Cohort 9: Paraganglioma-pheochromocytoma5
Cohort 10: Other Rare Tumor Histologies14

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: Squamous Cell Carcinoma of the Skin6Not reportedNot reportedNot reportedNot reported
Cohort 2: Small Cell Malignancies of Nonpulmonary Origin0Not reportedNot reportedNot reportedNot reported
Cohort 3: Adrenocortical Carcinoma1Not reportedNot reportedNot reportedNot reported
Cohort 4: Medullary Renal Cell Carcinoma0Not reportedNot reportedNot reportedNot reported
Cohort 5: Carcinoma of Unknown Primary5Not reportedNot reportedNot reportedNot reported
Cohort 6: Penile Carcinoma0Not reportedNot reportedNot reportedNot reported
Cohort 7: Vascular Sarcoma1Not reportedNot reportedNot reportedNot reported
Cohort 8: Germ Cell Tumor0Not reportedNot reportedNot reportedNot reported
Cohort 9: Paraganglioma-pheochromocytoma0Not reportedNot reportedNot reportedNot reported
Cohort 10: Other Rare Tumor Histologies1Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      16
    6. group Id
      OG005
      value
      2
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      5
    10. group Id
      OG009
      value
      14
    units
    Participants
description
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.
groups
  1. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG000
    title
    Cohort 1: Squamous Cell Carcinoma of the Skin
  2. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG001
    title
    Cohort 2: Small Cell Malignancies of Nonpulmonary Origin
  3. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG002
    title
    Cohort 3: Adrenocortical Carcinoma
  4. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG003
    title
    Cohort 4: Medullary Renal Cell Carcinoma
  5. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG004
    title
    Cohort 5: Carcinoma of Unknown Primary
  6. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG005
    title
    Cohort 6: Penile Carcinoma
  7. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG006
    title
    Cohort 7: Vascular Sarcoma
  8. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG007
    title
    Cohort 8: Germ Cell Tumor
  9. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG008
    title
    Cohort 9: Paraganglioma-pheochromocytoma
  10. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG009
    title
    Cohort 10: Other Rare Tumor Histologies
param Type
COUNT_OF_PARTICIPANTS
population Description
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.
reporting Status
POSTED
time Frame
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.
title
Evaluation of Tumor Size (Objective Response by irRECIST) to PD-L1 Status (CPS ≥1)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice