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NCT03582475 · OUTCOME

Duration of Response (DOR) Per RECIST 1.1 (Cohorts 1 and 2)

Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate · Source last updated 2025-11-12

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From the first documented CR or PR up to 3 years

What was measured

Duration of Response (DOR) defined as the time from the first documented CR or PR until radiograph disease progression or Prostate-Specific Antigen (PSA) progression.

Analysis population: one patient withdrew Cohort 2

Groups in this outcome

Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer

Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV

Cohort 2: Small Cell or Neuroendocrine Prostate Cancer

Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

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: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer7
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer7

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder CancerNANot reportedNANAMedian DOR is Not Available (NA) because none of the patients with a confirmed CR or PR had experienced radiographic or PSA progression at data cutoff. Over 50% remained progression-free, so the median could not be estimated.
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer12.6Not reported3.15NAmedian, upper and lower bounds of 95% Confidence Interval could not be estimated due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median DOR is Not Available (NA) because none of the patients with a confirmed CR or PR had experienced radiographic or PSA progression at data cutoff. Over 50% remained progression-free, so the median could not be estimated.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        median, upper and lower bounds of 95% Confidence Interval could not be estimated due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        3.15
        upper Limit
        NA
        value
        12.6
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Duration of Response (DOR) defined as the time from the first documented CR or PR until radiograph disease progression or Prostate-Specific Antigen (PSA) progression.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1 (Cohort 1). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Docetaxel: Given IV Etoposide: Given IV Pembrolizumab: Given IV
    id
    OG000
    title
    Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
  2. description
    Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Participants also receive standard of care chemotherapy comprising etoposide IV on days 1-3, carboplatin IV on day 1, and docetaxel IV on day 1 (Cohort 2). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
param Type
MEDIAN
population Description
one patient withdrew Cohort 2
reporting Status
POSTED
time Frame
From the first documented CR or PR up to 3 years
title
Duration of Response (DOR) Per RECIST 1.1 (Cohorts 1 and 2)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice