drugset / Trial / NCT05201547
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
RandomizedParallel-groupOpen-labelTreatment
Summary
Phase 3, randomized, multicentre study to evaluate the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient relapse or advanced endometrial cancer.
Timeline
- Start
- 2022-04-15
- Primary completion
- 2026-04
- Completion
- 2029-10
Outcome
Met primary endpoint
release “In a subsequent planned analysis, the RUBY trial met its other primary endpoint of OS” gsk.com ↗
release “RUBY Part 2: addition of niraparib to dostarlimab in maintenance setting significantly improved PFS” gsk.com ↗
release “Pivotal Phase 3 (Part 1) trial demonstrates JEMPERLI plus chemotherapy significantly improved PFS versus chemotherapy plus placebo in patients with primary advanced or recurrent endometrial cancer” anaptysbio.com ↗
Publications
- Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.
- Cherifi F, Ray-Coquard I, Rubio MJ, Paoletti X, Lorusso D, Choi CH, Hasegawa K, Tan DSP, Hudson E, Davis A, Tognon G, Lheureux S, Vardar Key MA, Kurtz JE, Alexandre J, Joly F. DOMENICA: dostarlimab versus chemotherapy alone in first-line MMR-deficient advanced endometrial cancer patients. Future Oncol. 2025 Jun;21(13):1613-1623. doi: 10.1080/14796694.2025.2496133. Epub 2025 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Dostarlimab | Monoclonal antibody | 1000 mg | Other |
| Subject | Pacltaxel | Unknown | 175 mg/m2 | Intravenous |