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

Conditions

• Squamous Cell Carcinoma of the Anal Canal

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• carboplatin — DRUG
  carboplatin will be administered intravenous on Day 1 of each 28 day cycle
• paclitaxel — DRUG
  paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle
• retifanlimab — DRUG
  retifanlimab will be administered intravenous on Day 1 of each 28 day cycle

Study Details

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.

Key Dates

Start date

Jan 12, 2021

Status verified

Oct 2025

Primary completion

Apr 15, 2024

Completion

Sep 26, 2025

Study Design

Enrollment

308 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Group A : carboplatin+paclitaxel+placebo
  Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and placebo on Day 1 of each 28 day cycle
• Experimental: Group B : carboplatin+paclitaxel+retifanlimab
  Participants will receive carboplatin on Day 1,paclitaxel on Day1,8, 15, and retifanlimab on Day 1 of each 28 day cycle

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: up to 33.9 months ]

Locations (14)

Find similar trials in Tucson, AZ