Retifanlimab (INCMGA00012)

DRUG7 trials

Sponsors

Incyte Corp., Region Skane, Incyte Biosciences International S.a.r.l., Amsterdam UMC, Institut Bergonie

Conditions

Adult patients with treatment-naïve surgically non-metastatic and resectable primary retroperitonealDedifferentiated LiposarcomaEndometrial cancerIn participants with PD-L1–positive and systemic therapy–naive R/M SCCHN.Metastatic nonsquamous or squamous non-small cell lung cancerMetastatic upper gastrointestinal cancerSquamous Carcinoma of the Anal Canalcancer of esophagus and stomach

Phase 2

PERELI - A phase 2, open label study of PEmigatinib and REtifanlimab in advanced dedifferentiated Liposarcoma

RecruitingCTIS2022-501993-21-00

Region SkaneDedifferentiated Liposarcoma

Start: 2024-06-20Target: 33Updated: 2025-10-15

INCMGA 0012-204: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

Active, not recruitingCTIS2022-502600-79-00

Incyte Corp.Endometrial cancer

Start: 2021-03-16Target: 88Updated: 2025-09-24

Anti-PD-1, Capecitabine, and Oxaliplatin for the first-line treatment of dMMR esophagogastric cancer (AuspiCiOus-dMMR): a proof-of-principle study

Active, not recruitingCTIS2023-509380-24-00

Amsterdam UMCcancer of esophagus and stomach, Metastatic upper gastrointestinal cancer

Start: 2021-11-01Target: 25Updated: 2024-04-03

TORNADO : RANDOMIZED PHASE II STUDY OF NEOADJUVANT CHEMOTHERAPY PLUS RETIFANLIMAB (INCMGA00012) IN PATIENTS WITH SELECTED RETROPERITONEAL SARCOMAS

Active, not recruitingCTIS2023-509498-21-00

Institut BergonieAdult patients with treatment-naïve surgically non-metastatic and resectable primary retroperitoneal, limbs and trunk wall undifferentiated pleomorphic sarcomas.

Start: 2022-03-16Target: 66Updated: 2025-09-23

A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti–LAG-3) and INCAGN02390 (Anti–TIM-3) as First-Line Treatment in Participants With PD-L1–Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Active, not recruitingCTIS2023-504270-38-00

Incyte Biosciences International S.a.r.l.In participants with PD-L1–positive and systemic therapy–naive R/M SCCHN.

Start: 2022-10-18Target: 66Updated: 2026-01-14

Phase 3

INCMGA 0012-303: 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)

CompletedCTIS2024-512331-72-00

Incyte Corp.Squamous Carcinoma of the Anal Canal

Start: 2020-12-22End: 2025-09-26Target: 201Updated: 2025-07-16

A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non–Small Cell Lung Cancer (POD1UM-304)

Active, not recruitingCTIS2022-501987-16-00

Incyte Corp.Metastatic nonsquamous or squamous non-small cell lung cancer

Start: 2020-10-02Target: 14Updated: 2025-08-05