NCT02499952 · STUDY IN CONTEXT

Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors

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

CBR of single agent pembrolizumab in subjects with refractory germ cell tumors (GCTs), determined by sum of complete responses, partial responses, and stable disease for at least 3 months using Immune Related Response Criteria (irRC). Complete Response(irPR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart. Partial Response (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation. Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD.

Source null

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secondary · POSTED

Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs. All grade 3 and higher adverse events are reported.

Source null

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secondary · POSTED

ORR of single agent pembrolizumab in subjects with refractory GCTs, determined by sum of complete responses and partial responses for at least 3 months using RECIST 1.1 criteria

Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.

→

secondary · POSTED

Duration of disease response

Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.

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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-germ-cell-tumor
nct id: NCT02499952
trial label: Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors
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: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-germ-cell-tumor
nct id
NCT02499952
outcome key
om-0000
source section id
NCT02499952-om-0000
source outcome index
0
endpoint
Clinical Benefit Rate (CBR)
endpoint definition
CBR of single agent pembrolizumab in subjects with refractory germ cell tumors (GCTs), determined by sum of complete responses, partial responses, and stable disease for at least 3 months using Immune Related Response Criteria (irRC). Complete Response(irPR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart. Partial Response (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation. Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD.
time origin
up to 18 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-germ-cell-tumor
nct id
NCT02499952
outcome key
om-0001
source section id
NCT02499952-om-0001
source outcome index
1
endpoint
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.
endpoint definition
Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs. All grade 3 and higher adverse events are reported.
time origin
Every week while patient is receiving pembrolizumab, assessed for up to 52 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-germ-cell-tumor
nct id
NCT02499952
outcome key
om-0002
source section id
NCT02499952-om-0002
source outcome index
2
endpoint
Disease Assessment for Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Criteria
endpoint definition
ORR of single agent pembrolizumab in subjects with refractory GCTs, determined by sum of complete responses and partial responses for at least 3 months using RECIST 1.1 criteria
time origin
From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.
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-germ-cell-tumor
nct id
NCT02499952
outcome key
om-0003
source section id
NCT02499952-om-0003
source outcome index
3
endpoint
Disease Assessment for Duration of Disease Response
endpoint definition
Duration of disease response
time origin
From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.
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-germ-cell-tumor
nct id
NCT02499952
outcome key
om-0000
arm key
OG000
arm label
Experimental Arm
regimen
Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02499952-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-germ-cell-tumor
nct id
NCT02499952
outcome key
om-0001
arm key
OG000
arm label
Experimental Arm
regimen
Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
analyzed count
12
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02499952-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-germ-cell-tumor
nct id
NCT02499952
outcome key
om-0002
arm key
OG000
arm label
Experimental Arm
regimen
Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02499952-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-germ-cell-tumor
nct id
NCT02499952
outcome key
om-0003
arm key
OG000
arm label
Experimental Arm
regimen
Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02499952-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-germ-cell-tumor
nct id
NCT02499952
harm key
EG000
source section id
NCT02499952-ae
event group key
EG000
event group label
Experimental Arm
serious affected
2
serious at risk
12
other affected
11
other at risk
12
frequency threshold
0
collection period
6 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