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NCT02721732 · OUTCOME

Immune-related ORR Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)

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.

Analysis population: 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.

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 Skin18
Cohort 2: Small Cell Malignancies of Nonpulmonary Origin12
Cohort 3: Adrenocortical Carcinoma20
Cohort 4: Medullary Renal Cell Carcinoma5
Cohort 5: Carcinoma of Unknown Primary26
Cohort 6: Penile Carcinoma3
Cohort 7: Vascular Sarcoma10
Cohort 8: Germ Cell Tumor11
Cohort 9: Paraganglioma-pheochromocytoma13
Cohort 10: Other Rare Tumor Histologies28

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 Carcinoma4Not 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 Carcinoma1Not reportedNot reportedNot reportedNot reported
Cohort 7: Vascular Sarcoma1Not reportedNot reportedNot reportedNot reported
Cohort 8: Germ Cell Tumor0Not reportedNot reportedNot reportedNot reported
Cohort 9: Paraganglioma-pheochromocytoma1Not reportedNot reportedNot reportedNot reported
Cohort 10: Other Rare Tumor Histologies5Not 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
        4
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      20
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      26
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      11
    9. group Id
      OG008
      value
      13
    10. group Id
      OG009
      value
      28
    units
    Participants
description
Immune-related ORR is defined as the percentage of patients achieving a irCR or irPR based on irRECIST criteria.
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
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.
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
Immune-related ORR Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice