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NCT02054806 · OUTCOME

Overall Response Rate (ORR)

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28) · Source last updated 2023-10-30

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 86 months

What was measured

Overall response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator.

Analysis population: The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type.

Groups in this outcome

Cohort A1: Colon or Rectal Adenocarcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.

Cohort A2: Anal Canal Squamous Cell Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.

Cohort A3: Pancreas Adenocarcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma.

Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).

Cohort A5: Biliary Tract Adenocarcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).

Cohort A6: Carcinoid Tumors

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with carcinoid tumors.

Cohort A7: Neuroendocrine Carcinomas

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).

Cohort B1: ER Positive HER2 Negative Breast Cancer

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with estrogen receptor (ER) positive human epidermal growth factor receptor (HER2) negative breast cancer.

Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.

Cohort B3: Endometrial Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with endometrial carcinoma.

Cohort B4: Cervical Squamous Cell Cancer

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.

Cohort B5: Vulvar Squamous Cell Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.

Cohort C1: Small Cell Lung Cancer

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with small cell lung cancer.

Cohort C2: Mesothelioma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with mesothelioma (malignant pleural mesothelioma).

Cohort D1: Thyroid Cancer

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with thyroid cancer (papillary or follicular subtype).

Cohort D2: Salivary Gland Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with salivary gland carcinoma.

Cohort D3: Nasopharyngeal Carcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with nasopharyngeal carcinoma.

Cohort E1: Glioblastoma Multiforme

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with glioblastoma multiforme.

Cohort E2: Leiomyosarcoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with leiomyosarcoma.

Cohort E3: Prostate Adenocarcinoma

Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with prostate adenocarcinoma.

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 A1: Colon or Rectal Adenocarcinoma23
Cohort A2: Anal Canal Squamous Cell Carcinoma25
Cohort A3: Pancreas Adenocarcinoma24
Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma23
Cohort A5: Biliary Tract Adenocarcinoma23
Cohort A6: Carcinoid Tumors25
Cohort A7: Neuroendocrine Carcinomas16
Cohort B1: ER Positive HER2 Negative Breast Cancer25
Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma26
Cohort B3: Endometrial Carcinoma23
Cohort B4: Cervical Squamous Cell Cancer24
Cohort B5: Vulvar Squamous Cell Carcinoma18
Cohort C1: Small Cell Lung Cancer23
Cohort C2: Mesothelioma25
Cohort D1: Thyroid Cancer22
Cohort D2: Salivary Gland Carcinoma26
Cohort D3: Nasopharyngeal Carcinoma27
Cohort E1: Glioblastoma Multiforme25
Cohort E2: Leiomyosarcoma24
Cohort E3: Prostate Adenocarcinoma23

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A1: Colon or Rectal Adenocarcinoma4.3Not reported0.121.9Not reported
Cohort A2: Anal Canal Squamous Cell Carcinoma20.0Not reported6.840.7Not reported
Cohort A3: Pancreas Adenocarcinoma0.0Not reported0.014.2Not reported
Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma30.4Not reported13.252.9Not reported
Cohort A5: Biliary Tract Adenocarcinoma17.4Not reported5.038.8Not reported
Cohort A6: Carcinoid Tumors16.0Not reported4.536.1Not reported
Cohort A7: Neuroendocrine Carcinomas6.3Not reported0.230.2Not reported
Cohort B1: ER Positive HER2 Negative Breast Cancer12.0Not reported2.531.2Not reported
Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma11.5Not reported2.430.2Not reported
Cohort B3: Endometrial Carcinoma13.0Not reported2.833.6Not reported
Cohort B4: Cervical Squamous Cell Cancer16.7Not reported4.737.4Not reported
Cohort B5: Vulvar Squamous Cell Carcinoma5.6Not reported0.127.3Not reported
Cohort C1: Small Cell Lung Cancer34.8Not reported16.457.3Not reported
Cohort C2: Mesothelioma20.0Not reported6.840.7Not reported
Cohort D1: Thyroid Cancer13.6Not reported2.934.9Not reported
Cohort D2: Salivary Gland Carcinoma11.5Not reported2.430.2Not reported
Cohort D3: Nasopharyngeal Carcinoma25.9Not reported11.146.3Not reported
Cohort E1: Glioblastoma Multiforme8.0Not reported1.026.0Not reported
Cohort E2: Leiomyosarcoma4.2Not reported0.121.1Not reported
Cohort E3: Prostate Adenocarcinoma13.0Not reported2.833.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        21.9
        value
        4.3
      2. group Id
        OG001
        lower Limit
        6.8
        upper Limit
        40.7
        value
        20.0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        14.2
        value
        0.0
      4. group Id
        OG003
        lower Limit
        13.2
        upper Limit
        52.9
        value
        30.4
      5. group Id
        OG004
        lower Limit
        5.0
        upper Limit
        38.8
        value
        17.4
      6. group Id
        OG005
        lower Limit
        4.5
        upper Limit
        36.1
        value
        16.0
      7. group Id
        OG006
        lower Limit
        0.2
        upper Limit
        30.2
        value
        6.3
      8. group Id
        OG007
        lower Limit
        2.5
        upper Limit
        31.2
        value
        12.0
      9. group Id
        OG008
        lower Limit
        2.4
        upper Limit
        30.2
        value
        11.5
      10. group Id
        OG009
        lower Limit
        2.8
        upper Limit
        33.6
        value
        13.0
      11. group Id
        OG010
        lower Limit
        4.7
        upper Limit
        37.4
        value
        16.7
      12. group Id
        OG011
        lower Limit
        0.1
        upper Limit
        27.3
        value
        5.6
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      24
    4. group Id
      OG003
      value
      23
    5. group Id
      OG004
      value
      23
    6. group Id
      OG005
      value
      25
    7. group Id
      OG006
      value
      16
    8. group Id
      OG007
      value
      25
    9. group Id
      OG008
      value
      26
    10. group Id
      OG009
      value
      23
    11. group Id
      OG010
      value
      24
    12. group Id
      OG011
      value
      18
    units
    Participants
description
Overall response rate (ORR) was defined as the percentage of participants who experienced a complete response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by the investigator.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with colon or rectal adenocarcinoma.
    id
    OG000
    title
    Cohort A1: Colon or Rectal Adenocarcinoma
  2. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with anal canal squamous cell carcinoma.
    id
    OG001
    title
    Cohort A2: Anal Canal Squamous Cell Carcinoma
  3. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with pancreas adenocarcinoma.
    id
    OG002
    title
    Cohort A3: Pancreas Adenocarcinoma
  4. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal (GE) junction).
    id
    OG003
    title
    Cohort A4: Esophageal Squamous Cell Carcinoma or Adenocarcinoma
  5. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with biliary tract adenocarcinoma (gallbladder and biliary tree, but excluding ampulla of vater cancers).
    id
    OG004
    title
    Cohort A5: Biliary Tract Adenocarcinoma
  6. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with carcinoid tumors.
    id
    OG005
    title
    Cohort A6: Carcinoid Tumors
  7. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor).
    id
    OG006
    title
    Cohort A7: Neuroendocrine Carcinomas
  8. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with estrogen receptor (ER) positive human epidermal growth factor receptor (HER2) negative breast cancer.
    id
    OG007
    title
    Cohort B1: ER Positive HER2 Negative Breast Cancer
  9. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with ovarian epithelial, fallopian tube or primary peritoneal carcinoma.
    id
    OG008
    title
    Cohort B2: Ovarian Epithelial, Fallopian Tube or Primary Peritoneal Carcinoma
  10. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with endometrial carcinoma.
    id
    OG009
    title
    Cohort B3: Endometrial Carcinoma
  11. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with cervical squamous cell cancer.
    id
    OG010
    title
    Cohort B4: Cervical Squamous Cell Cancer
  12. description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes once every 2 weeks (Q2W) for up to \~2 years. This cohort represents all participants who enrolled with vulvar squamous cell carcinoma.
    id
    OG011
    title
    Cohort B5: Vulvar Squamous Cell Carcinoma
param Type
NUMBER
population Description
The analysis population consisted of all participants who received at least 1 dose of study treatment, had a baseline scan with measurable disease per modified RECIST 1.1 and had the intended indication. Per protocol, participants were analyzed according to disease type.
reporting Status
POSTED
time Frame
Up to approximately 86 months
title
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice