NCT04231981 · STUDY IN CONTEXT

Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)

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. 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

The primary efficacy endpoint for the study is the ORR. The ORR is defined as the number of patients with CR and PR divided by the number of patients in the analysis set. Tumor response will be defined as best response based on local investigator's assessment according to RECIST criteria v.1.1.

Source null

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secondary · POSTED

CBR is defined as the number of patients with CR, partial response (PR) or stable disease (SD) (for at least 12 weeks) divided by the number of patients in the analysis set.

Source null

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secondary · POSTED

PFS is defined as the time from the date of the first dose of study treatment until the first documented PD based on RECIST v1.1. or death due to any cause, whichever occurs first based on local investigator's assessment according to RECIST criteria v1.1.

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secondary · POSTED

6-months PFS rate is defined as the proportion of patients who are alive and progression-free at 6 months from the date of first dose of study treatment based on iRECIST criteria.

Source null

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secondary · POSTED

DoR is defined as the time from first documented CR or PR until disease progression or death from any cause, based on local investigator's assessment according to RECIST criteria v1.1.

Source null

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secondary · POSTED

OS is defined as the time from the date of first dose of study treatment until death by any cause or the last date the patient was known to be alive.

Source null

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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-penile-cancer
nct id: NCT04231981
trial label: Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS)
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.
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: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT04231981
outcome key
om-0000
source section id
NCT04231981-om-0000
source outcome index
0
endpoint
Objective Response Rate (ORR)
endpoint definition
The primary efficacy endpoint for the study is the ORR. The ORR is defined as the number of patients with CR and PR divided by the number of patients in the analysis set. Tumor response will be defined as best response based on local investigator's assessment according to RECIST criteria v.1.1.
time origin
From baseline until disease progression or treatment discontinuation, up to 10.3 months
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-penile-cancer
nct id
NCT04231981
outcome key
om-0001
source section id
NCT04231981-om-0001
source outcome index
1
endpoint
Efficacy Determined by Clinical Benefit Rate (CBR)
endpoint definition
CBR is defined as the number of patients with CR, partial response (PR) or stable disease (SD) (for at least 12 weeks) divided by the number of patients in the analysis set.
time origin
From baseline until disease progression or treatment discontinuation, up to 10.3 months
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-penile-cancer
nct id
NCT04231981
outcome key
om-0002
source section id
NCT04231981-om-0002
source outcome index
2
endpoint
Efficacy Determined by Progression-free Survival (PFS)
endpoint definition
PFS is defined as the time from the date of the first dose of study treatment until the first documented PD based on RECIST v1.1. or death due to any cause, whichever occurs first based on local investigator's assessment according to RECIST criteria v1.1.
time origin
From baseline until disease progression or treatment discontinuation, up to 10.3 months
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-penile-cancer
nct id
NCT04231981
outcome key
om-0003
source section id
NCT04231981-om-0003
source outcome index
3
endpoint
Efficacy Determined by 6-months PFS
endpoint definition
6-months PFS rate is defined as the proportion of patients who are alive and progression-free at 6 months from the date of first dose of study treatment based on iRECIST criteria.
time origin
Baseline up to 6 months
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-penile-cancer
nct id
NCT04231981
outcome key
om-0004
source section id
NCT04231981-om-0004
source outcome index
4
endpoint
Efficacy Determined by Duration of Response (DoR)
endpoint definition
DoR is defined as the time from first documented CR or PR until disease progression or death from any cause, based on local investigator's assessment according to RECIST criteria v1.1.
time origin
From baseline until disease progression or treatment discontinuation, up to 10.3 months
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-penile-cancer
nct id
NCT04231981
outcome key
om-0005
source section id
NCT04231981-om-0005
source outcome index
5
endpoint
Efficacy Determined by Overall Survival (OS)
endpoint definition
OS is defined as the time from the date of first dose of study treatment until death by any cause or the last date the patient was known to be alive.
time origin
From baseline until disease progression or treatment discontinuation, up to 10.3 months
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

arms

release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT04231981
outcome key
om-0000
arm key
OG000
arm label
Interventional Arm
regimen
Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04231981-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT04231981
outcome key
om-0001
arm key
OG000
arm label
Interventional Arm
regimen
Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04231981-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT04231981
outcome key
om-0002
arm key
OG000
arm label
Interventional Arm
regimen
Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04231981-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT04231981
outcome key
om-0003
arm key
OG000
arm label
Interventional Arm
regimen
Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04231981-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT04231981
outcome key
om-0004
arm key
OG000
arm label
Interventional Arm
regimen
Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04231981-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT04231981
outcome key
om-0005
arm key
OG000
arm label
Interventional Arm
regimen
Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle. Retifanlimab: INCMGA00012 500 mg will be administered on Day1 of each cycle (once every four weeks), for up to 2 years.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04231981-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT04231981
harm key
EG000
source section id
NCT04231981-ae
event group key
EG000
event group label
Interventional Arm
serious affected
5
serious at risk
18
other affected
5
other at risk
18
frequency threshold
0
collection period
From baseline until disease progression or treatment discontinuation, plus 28 days of follow-up after discontinuation (up to approximately 11.3 months)
event definition
The investigator or investigator's team will report all protocol defined SAEs and ECIs to the Sponsor (MedSIR) no later than 24 hours of any site study team staff becoming aware of the event. The full details of the SAE and/or ECI should be collected and fully documented using theSAE form. Follow-up information will be sent along with the SAE form, if available on the day the event is reported or as soon as possible.
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