NCT03582475 · OUTCOME

Percentage of Participants With Programmed Death-ligand 1 (PD-L1) Combined Positive Score (CPS) Greater Than 10, at 12 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: Percentage of patients with (CPS) > 10
Interval / dispersion: Not reported
Time frame: at 12 months

Analysis population: PD-L1% (defined CPS\>10). combined positive score (CPS). CPS defined as number of PD-L1 staining cells in tumor, lymphocytes, and macrophages divided by total number viable tumor cells x 100.

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

Source class 1

Values in Percentage of patients with (CPS) > 10 · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer	42.8	Not reported	Not reported	Not reported	Not reported
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer	37.5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
42.8
group Id
OG001
value
37.5

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

population Description

PD-L1% (defined CPS\>10). combined positive score (CPS). CPS defined as number of PD-L1 staining cells in tumor, lymphocytes, and macrophages divided by total number viable tumor cells x 100.

reporting Status

POSTED

time Frame

at 12 months

title

Percentage of Participants With Programmed Death-ligand 1 (PD-L1) Combined Positive Score (CPS) Greater Than 10, at 12 Months

type

OTHER_PRE_SPECIFIED

unit Of Measure

Percentage of patients with (CPS) > 10

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

Preserved source evidence · Not medical advice