CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 308 enrolled
Drug / intervention
carboplatin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04472429
NCT04472429Phase 3Completed
CompareCT.gov

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)

Incyte Corporation·interventional·Posted Jul 15, 2020·Updated Nov 3, 2025

In Brief

A Phase 3 clinical trial evaluating carboplatin, paclitaxel, and 1 other intervention for Squamous Cell Carcinoma of the Anal Canal. Completed, enrolled 308 participants across 84 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSquamous Cell Carcinoma of the Anal Canal
CountriesAustralia, Belgium, Denmark, France, Germany, Italy, Japan, Norway, Puerto Rico, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJul 15, 2020
Enrollment StartJan 12, 2021
Primary CompletionApr 15, 2024
Study CompletionSep 26, 2025
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.0 years ago

Interventions

carboplatindrug

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

paclitaxeldrug

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

retifanlimabdrug

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