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NCT03582475 · OUTCOME

Proportion of Participants With Overall Survival of Cohort 1 and 2 at 12 and 24 Months

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
NUMBER
Unit
Proportion of patients
Interval / dispersion
95% Confidence Interval
Time frame
12 months and 24 months.

What was measured

Overall Survival (OS) defined as the time from the first day of study treatment to the time of death from any cause.

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

12 months
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer0.86Not reported0.631.00Not reported
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer0.71Not reported0.451.00Not reported
24 months
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer0.86Not reported0.631.00Not reported
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer0.57Not reported0.301.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.63
        upper Limit
        1.00
        value
        0.86
      2. group Id
        OG001
        lower Limit
        0.45
        upper Limit
        1.00
        value
        0.71
    title
    12 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.63
        upper Limit
        1.00
        value
        0.86
      2. group Id
        OG001
        lower Limit
        0.30
        upper Limit
        1.00
        value
        0.57
    title
    24 months
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Overall Survival (OS) defined as the time from the first day of study treatment to the time of death from any cause.
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
NUMBER
population Description
one patient withdrew Cohort 2
reporting Status
POSTED
time Frame
12 months and 24 months.
title
Proportion of Participants With Overall Survival of Cohort 1 and 2 at 12 and 24 Months
type
PRIMARY
unit Of Measure
Proportion of patients

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

Preserved source evidence · Not medical advice