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

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.

Timeline

Start

2020-11-09

Primary completion

2024-04-15

Completion

2025-09-26

Outcome

Met primary endpoint

registry analysis (superiority test); Retifanlimab 500 mg Q4W + Chemotherapy vs Placebo + Chemotherapy; p = 0.0006; Hazard Ratio (HR) 0.63 (95% CI 0.47 to 0.84) NCT04472429 ↗

release “The EC approval is based on results of the POD1UM-303 study which showed that adult patients with advanced SCAC achieved significantly improved progression-free survival” incyte.com ↗

Publications

• Rao S, Samalin-Scalzi E, Evesque L, Ben Abdelghani M, Morano F, Roy A, Dahan L, Tamberi S, Dhadda AS, Saunders MP, Casanova N, Guimbaud R, Lievre A, Maurel J, Fakih M, Tian C, Harrison J, Jones MM, Cornfeld M, Spano JP, Rochefort P; POD1UM-303/InterAACT-2 study investigators. 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. 2025 Jun 14;405(10495):2144-2152. doi: 10.1016/S0140-6736(25)00631-2.
• Rao S, Jones M, Bowman J, Tian C, Spano JP. 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. Front Oncol. 2022 Aug 24;12:935383. doi: 10.3389/fonc.2022.935383. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Retifanlimab	Monoclonal antibody	500 mg	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Indications