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Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).

NCT04472429Phase 3Completed

Lead sponsor
Incyte Corporation (Industry)
Enrollment
308 (actual)
Start date
9 Nov 2020
Primary completion
15 Apr 2024 (actual)
Study completion
26 Sep 2025
Last update posted
25 Sep 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • carboplatin Drug
  • paclitaxel Drug
  • retifanlimab Drug

Conditions and primary outcome

  • Squamous Cell Carcinoma of the Anal Canal

Primary outcome

Progression-free Survival (PFS) (up to 33.9 months)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT04472429 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Progression-free Survival (PFS)

    Time frame
    up to 33.9 months
    Measure
    Median
    Unit
    months

    • Retifanlimab 500 mg Q4W + Chemotherapy vs Placebo + ChemotherapySuperiority

      Estimate
      0.63Hazard Ratio (HR)
      95% CI, two-sided
      0.47 to 0.84
      p-value
      0.0006
      Method
      stratified log-rank test

Serious adverse events

Time frame: up to approximately 57 months

Participants with serious adverse events per group for NCT04472429, as posted
GroupAffectedAt risk
Placebo + Chemotherapy59152
Retifanlimab 500 mg Q4W + Chemotherapy73154
Randomized Period Total132306
Retifanlimab 500 mg Q4W1977

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

  1. Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial.

    Lancet (London, England) · 2025 Jun 14

    PubMed 40517007 (opens in a new tab)DOI 10.1016/S0140-6736(25)00631-2 (opens in a new tab)

  2. POD1UM-303/InterAACT 2: A phase III, global, randomized, double-blind study of retifanlimab or placebo plus carboplatin-paclitaxel in patients with locally advanced or metastatic squamous cell anal carcinoma.

    Frontiers in oncology · 2022

    PubMed 36091159 (opens in a new tab)DOI 10.3389/fonc.2022.935383 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.