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NCT04472429 · OUTCOME

AUC of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel

Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). · Source last updated 2026-09-02

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

Measure
GEOMETRIC_MEAN
Unit
day x mg/L
Interval / dispersion
Geometric Coefficient of Variation
Time frame
preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4

What was measured

AUC was defined as the area under the serum concentration versus time curve.

Analysis population: PK Evaluable Population

Groups in this outcome

Retifanlimab 500 mg Q4W + Chemotherapy

Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).

Placebo + Chemotherapy

Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.

Retifanlimab 500 mg Q4W

In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).

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 mg Q4W + Chemotherapy150
Placebo + Chemotherapy0
Retifanlimab 500 mg Q4W0

Reported measurements

Source class 1
Values in day x mg/L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Retifanlimab 500 mg Q4W + Chemotherapy249040.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.1
        value
        2490
denoms
  1. counts
    1. group Id
      OG000
      value
      150
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
AUC was defined as the area under the serum concentration versus time curve.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
    id
    OG000
    title
    Retifanlimab 500 mg Q4W + Chemotherapy
  2. description
    Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
    id
    OG001
    title
    Placebo + Chemotherapy
  3. description
    In the optional monotherapy treatment period, participants randomized to placebo + chemotherapy who experienced documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) verified by the blinded independent review committee (BICR) had the opportunity to receive open-label retifanlimab monotherapy for up to thirteen 28-day cycles (1 year).
    id
    OG002
    title
    Retifanlimab 500 mg Q4W
param Type
GEOMETRIC_MEAN
population Description
PK Evaluable Population
reporting Status
POSTED
time Frame
preinfusion on Day 1 of Cycles 1, 2, 4, 6, 8, and 12; immediately after infusion on Day 1 of Cycles 1 and 4
title
AUC of Retifanlimab at Steady State When Administered With Carboplatin-paclitaxel
type
SECONDARY
unit Of Measure
day x mg/L

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

Preserved source evidence · Not medical advice