NCT03582475 · OUTCOME

Percentage of Participants With Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (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: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Up to 3 years

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

Group	Source count
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer	7
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer	7

Reported measurements

Grade 3 or higher

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer	57	Not reported	Not reported	Not reported	Not reported
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer	25	Not reported	Not reported	Not reported	Not reported

All Grades

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer	100	Not reported	Not reported	Not reported	Not reported
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer	75	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
57
group Id
OG001
value
25
title
Grade 3 or higher
categories
measurements
group Id
OG000
value
100
group Id
OG001
value
75
title
All Grades

denoms

counts
group Id
OG000
value
7
group Id
OG001
value
7
units
Participants

groups

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
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

reporting Status

POSTED

time Frame

Up to 3 years

title

Percentage of Participants With Adverse Events Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Cohorts 1 and 2)

type

PRIMARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice