NCT03582475 · STUDY IN CONTEXT

Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Durable Response Rate (DRR) defined as the proportion of patients who achieved a confirmed complete or partial response (CR or PR) and maintained that response for at least 6 months.

one patient withdrew Cohort 2

→

primary · POSTED

Overall Response Rate (ORR) defined as patients by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 exhibited a complete or partial response (CR or PR). CR defined as disappearance of all target lesions. PR defined as \>= 30% decrease in sum of the longest diameter of target lesions. .

one patient withdrew Cohort 2

→

primary · POSTED

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.

one patient withdrew Cohort 2

→

primary · POSTED

Progression Free Survival (PFS) defined as the time from the first day of study treatment to first documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesion(s).

Proportion of Participants with Progression Free Survival at 12 and 24 Months was measured using sample size of each cohort and incidence of events to provide confidence intervals.

→

primary · POSTED

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

one patient withdrew Cohort 2

→

primary · POSTED

PCWG3 is specifically designed for prostate cancer and incorporates both soft tissue and bone response assessment. RECIST 1.1 is used for evaluating responses in solid tumors, while PCWG3 combines Response evaluation criteria in solid tumors (RECIST)1.1 for soft tissue assessment with specific criteria for bone scans. The PCWG3 response criteria was used to report the portion of participants with rPFS at their 12 and 24 month assessments.

The Primary outcome of Radiographic PFS (rPFS) with response criteria based off Prostate Cancer Working Group 3 (PCWG3) only applies to Prostate cancer patients enrolled into cohort 2. This criteria does not apply to Bladder cancer patients that enrolled in Cohort 1.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-urethral-cancer
nct id: NCT03582475
trial label: Pembrolizumab With Combination Chemotherapy in Treating Participants With Locally Advanced or Metastatic Small Cell/Neuroendocrine Cancers of Urothelium or Prostate
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0000
source section id
NCT03582475-om-0000
source outcome index
0
endpoint
Durable Response Rate (DRR) (Cohorts 1 and 2)
endpoint definition
Durable Response Rate (DRR) defined as the proportion of patients who achieved a confirmed complete or partial response (CR or PR) and maintained that response for at least 6 months.
time origin
At 6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
one patient withdrew Cohort 2
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0001
source section id
NCT03582475-om-0001
source outcome index
1
endpoint
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Cohorts 1 and 2)
endpoint definition
Overall Response Rate (ORR) defined as patients by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 exhibited a complete or partial response (CR or PR). CR defined as disappearance of all target lesions. PR defined as \>= 30% decrease in sum of the longest diameter of target lesions. .
time origin
Up to 3 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
one patient withdrew Cohort 2
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0002
source section id
NCT03582475-om-0002
source outcome index
2
endpoint
Duration of Response (DOR) Per RECIST 1.1 (Cohorts 1 and 2)
endpoint definition
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.
time origin
From the first documented CR or PR up to 3 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
one patient withdrew Cohort 2
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0003
source section id
NCT03582475-om-0003
source outcome index
3
endpoint
Proportion of Participants With Progression Free Survival at 12 and 24 Months
endpoint definition
Progression Free Survival (PFS) defined as the time from the first day of study treatment to first documented disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesion(s).
time origin
12 months and 24 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Proportion of Participants with Progression Free Survival at 12 and 24 Months was measured using sample size of each cohort and incidence of events to provide confidence intervals.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0004
source section id
NCT03582475-om-0004
source outcome index
4
endpoint
Proportion of Participants With Overall Survival of Cohort 1 and 2 at 12 and 24 Months
endpoint definition
Overall Survival (OS) defined as the time from the first day of study treatment to the time of death from any cause.
time origin
12 months and 24 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
one patient withdrew Cohort 2
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0005
source section id
NCT03582475-om-0005
source outcome index
5
endpoint
Portion of Participants With Radiographic Progression-free Survival (rPFS) by Prostate Cancer Working Group 3 (PCWG3) at 12 and 24 Months (Cohort 2)
endpoint definition
PCWG3 is specifically designed for prostate cancer and incorporates both soft tissue and bone response assessment. RECIST 1.1 is used for evaluating responses in solid tumors, while PCWG3 combines Response evaluation criteria in solid tumors (RECIST)1.1 for soft tissue assessment with specific criteria for bone scans. The PCWG3 response criteria was used to report the portion of participants with rPFS at their 12 and 24 month assessments.
time origin
12 months and 24 months.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The Primary outcome of Radiographic PFS (rPFS) with response criteria based off Prostate Cancer Working Group 3 (PCWG3) only applies to Prostate cancer patients enrolled into cohort 2. This criteria does not apply to Bladder cancer patients that enrolled in Cohort 1.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0000
arm key
OG000
arm label
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
regimen
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
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0000
arm key
OG001
arm label
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
regimen
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.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0001
arm key
OG000
arm label
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
regimen
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
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0001
arm key
OG001
arm label
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
regimen
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.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0002
arm key
OG000
arm label
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
regimen
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
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0002
arm key
OG001
arm label
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
regimen
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.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0003
arm key
OG000
arm label
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
regimen
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
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0003
arm key
OG001
arm label
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
regimen
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.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0004
arm key
OG000
arm label
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
regimen
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
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0004
arm key
OG001
arm label
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
regimen
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.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0005
arm key
OG000
arm label
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
regimen
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
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
outcome key
om-0005
arm key
OG001
arm label
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
regimen
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.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03582475-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
harm key
EG000
source section id
NCT03582475-ae
event group key
EG000
event group label
Cohort 1: Metastatic or Locally Advanced Naive Small Cell Bladder Cancer
serious affected
7
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urethral-cancer
nct id
NCT03582475
harm key
EG001
source section id
NCT03582475-ae
event group key
EG001
event group label
Cohort 2: Small Cell or Neuroendocrine Prostate Cancer
serious affected
7
serious at risk
8
other affected
6
other at risk
8
frequency threshold
5
collection period
Adverse events are collected form consent to 90 days post treatment with a median follow up of 34 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice