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INCAGN02385

DRUG7 trials

Sponsors

Incyte Corp., Incyte Biosciences International S.a.r.l., Incyte Biosciences International Sàrl, Incyte Corporation

Conditions

Cervical CancerDiffuse Large B-cell LymphomaEndometrial CancerEndometrial cancerEsophageal CancerGastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])Head and Neck CancerHepatocellular Carcinoma

Phase 1

A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
CompletedNCT03538028
Incyte Biosciences International SàrlCervical Cancer, Diffuse Large B-cell Lymphoma, Esophageal Cancer +14
Start: 2018-06-18End: 2020-10-07Updated: 2020-10-30
Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies
CompletedNCT04370704
Incyte CorporationMelanoma
Start: 2020-07-27End: 2025-08-25Updated: 2025-10-03

Phase 2

Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.
Active, not recruitingNCT04463771
Incyte CorporationEndometrial Cancer
Start: 2021-01-26End: 2026-07-10Updated: 2025-12-10
An Umbrella Study to Determine the Safety and Efficacy of Various Monotherapy or Combination Therapies in Neoadjuvant Urothelial Carcinoma
TerminatedNCT04586244
Incyte CorporationUrothelial Carcinoma
Start: 2022-01-14End: 2024-01-29Updated: 2025-10-30
Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Active, not recruitingNCT05287113
Incyte Biosciences International SàrlHead and Neck Cancer
Start: 2022-11-14End: 2026-07-10Updated: 2026-03-27
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
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

Related Papers

A phase 1/2 study of retifanlimab (INCMGA00012, Anti–PD-1), INCAGN02385 (Anti–LAG-3), and INCAGN02390 (Anti–TIM-3) combination therapy in patients (Pts) with advanced solid tumors.
Journal of Clinical Oncology2023-06-017 citations
Phase 2 trial of retifanlimab (anti–PD-1) in combination with INCAGN02385 (anti–LAG-3) and INCAGN02390 (anti–TIM-3) as first-line treatment in patients with PD-L1–positive recurrent/metastatic squamous cell carcinoma of the head and neck.
Journal of Clinical Oncology2023-06-015 citations
Randomized phase 2 umbrella study of various neoadjuvant therapies for patients with muscle-invasive urothelial carcinoma of the bladder (MIBC) who are cisplatin-ineligible or refuse cisplatin therapy and undergoing radical cystectomy (Optimus).
Journal of Clinical Oncology2022-02-161 citations
348 A phase 2 umbrella study of retifanlimab (INCMGA00012) alone or in combination with other therapies in patients with advanced or metastatic endometrial cancer (POD1UM-204, GOG 3038, ENGOT-en12/NOGGO)
Regular and Young Investigator Award Abstracts2020-11-014 citations