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R-DXd

BIOLOGICAL6 trials

Sponsors

Merck Sharp & Dohme LLC, Daiichi Sankyo

Conditions

Endometrioid Epithelial OvarianFallopian Tube CancerHigh-Grade Serous Ovarian CancerLung NeoplasmOvarian CancerOvarian NeoplasmsPeritoneal CancerPrimary Peritoneal Cancer

Phase 1

Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)
Active, not recruitingNCT04938817
Merck Sharp & Dohme LLCSmall Cell Lung Carcinoma
Start: 2021-08-19End: 2029-12-10Target: 110Updated: 2026-06-01

Phase 2

A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
RecruitingNCT06161025
Daiichi SankyoSolid Cancer
Start: 2024-02-27End: 2030-04-30Target: 860Updated: 2026-07-28
Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)
RecruitingNCT06780098
Merck Sharp & Dohme LLCLung Neoplasm
Start: 2025-05-28End: 2032-03-02Target: 144Updated: 2026-08-25

Phase 3

A Clinical Trial of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab in Participants With Ovarian Cancer Who Have Progressed During Treatment With PARP-inhibitors Treatment on First Line Maintenance (MK-5909-008/ENGOT-ov107/GOG-3142 / REJOICE-Ovarian05)
Not yet recruitingNCT07743164
Merck Sharp & Dohme LLCFallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Start: 2026-10-05End: 2031-08-31Target: 646Updated: 2026-09-11
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Not yet recruitingNCT07776691
Merck Sharp & Dohme LLCFallopian Tube Cancer, Ovarian Cancer, Ovarian Neoplasms +1
Start: 2026-09-22End: 2034-10-22Target: 802Updated: 2026-09-11
A Study of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab as Maintenance Therapy in Second-Line Platinum-Sensitive Recurrent Ovarian Cancer (REJOICE-Ovarian03)
Not yet recruitingNCT07791732
Daiichi SankyoEndometrioid Epithelial Ovarian, Fallopian Tube Cancer, High-Grade Serous Ovarian Cancer +1
Start: 2026-10-01End: 2033-12-01Target: 600Updated: 2026-09-01

Related Papers

REJOICE-Ovarian01: Phase 3 part of a phase 2/3 study evaluating raludotatug deruxtecan (R-DXd) versus treatment of physician’s choice in patients with platinum-resistant ovarian cancer.
Journal of Clinical Oncology2026-05-28
Exposure–response (E–R) analyses of efficacy and safety with raludotatug deruxtecan (R-DXd), a CDH6-directed antibod-drug conjugate (ADC), to inform dose selection for phase (Ph) 3 development in platinum-resistant ovarian cancer (PROC).
Journal of Clinical Oncology2026-05-27
Abstract 1820: Pharmacokinetic-tumor growth inhibition modeling of raludotatug deruxtecan (R-DXd) to support phase 3 dose selection in platinum-resistant ovarian cancer (PROC).
Cancer Research2026-04-03
REJOICE-PanTumor01: A phase 2 signal-seeking study of raludotatug deruxtecan (R-DXd) in patients with advanced or metastatic gynecologic or genitourinary tumors.
Journal of Clinical Oncology2025-05-28
Pharmacokinetic-pharmacodynamic analysis of myelosuppression with raludotatug deruxtecan (R-DXd) in patients with advanced solid tumors
2025-02-18
REJOICE-Ovarian01: A phase 2/3 study of raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer (OVC).
Journal of Clinical Oncology2024-06-017 citations
Abstract CT256: Results from KEYNOTE-B98: A phase 1b/2 study of pembrolizumab plus investigational agents in patients with anti-PD-(L)1-refractory extensive-stage small-cell lung cancer (ES-SCLC)
Cancer Research2024-04-052 citations