NCT04472429

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

A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 308 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Squamous Cell Carcinoma of the Anal Canal

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-01-12
• Primary completion: 2024-04-15
• Completion: 2025-09-26
• First posted: 2020-07-15
• Last updated: 2025-11-03
• Results posted: 2025-05-23

Locations

84 sites across 13 countries: United States, Australia, Belgium, Denmark, France, Germany, Italy, Japan, Norway, Puerto Rico, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study