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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).

NCT04472429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2025-11-03

Study results available
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Summary

This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.

Conditions

Interventions

DRUG

carboplatin

carboplatin will be administered intravenous on Day 1 of each 28 day cycle

DRUG

paclitaxel

paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle

DRUG

retifanlimab

retifanlimab will be administered intravenous on Day 1 of each 28 day cycle

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-12
Primary Completion
2024-04-15
Completion
2025-09-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Norway
  • Puerto Rico
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04472429 on ClinicalTrials.gov