NCT04231981 · OUTCOME

Efficacy Determined by Clinical Benefit Rate (CBR)

Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS) · Source last updated 2025-05-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From baseline until disease progression or treatment discontinuation, up to 10.3 months

What was measured

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.

Groups in this outcome

Interventional Arm

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.

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
Interventional Arm	18

Reported measurements

Source class 1

Yes

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Interventional Arm	4	Not reported	Not reported	Not reported	Not reported

No

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Interventional Arm	14	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
4
title
Yes
measurements
group Id
OG000
value
14
title
No

denoms

counts
group Id
OG000
value
18
units
Participants

description

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.

groups

description
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.
id
OG000
title
Interventional Arm

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

From baseline until disease progression or treatment discontinuation, up to 10.3 months

title

Efficacy Determined by Clinical Benefit Rate (CBR)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice