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NCT03597295 · OUTCOME

Objective Response Rate (ORR)

A Study of INCMGA00012 in Squamous Carcinoma of the Anal Canal Following Platinum-Based Chemotherapy (POD1UM-202) · Source last updated 2025-08-21

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months

What was measured

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as assessed by independent central radiographic (ICR) review, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.

Analysis population: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of study drug

Groups in this outcome

Retifanlimab 500 mg

Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Retifanlimab 500 mg94

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Retifanlimab 500 mg13.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13.8
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    units
    Participants
description
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as assessed by independent central radiographic (ICR) review, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
groups
  1. description
    Participants received retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
    id
    OG000
    title
    Retifanlimab 500 mg
param Type
NUMBER
population Description
Full Analysis Set: all participants enrolled in the study who received at least 1 dose of study drug
reporting Status
POSTED
time Frame
Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
title
Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice