A Study of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab as Maintenance Therapy in Second-Line Platinum-Sensitive Recurrent Ovarian Cancer (REJOICE-Ovarian03)

Sponsor
Daiichi Sankyo
Study ID
NCT07791732
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Endometrioid Epithelial Ovarian
  • Fallopian Tube Cancer
  • High-Grade Serous Ovarian Cancer
  • Primary Peritoneal Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • R-DXd — DRUG
    R-DXd will be administered as an intravenous (IV) infusion.
  • Bevacizumab — DRUG
    Bevacizumab will be administered as an IV infusion.

Study Details

The primary purpose of the study is to evaluate the efficacy of R-DXd with or without bevacizumab as maintenance therapy compared with standard of care (SOC) in participants with platinum-sensitive ovarian cancer (PSOC) as measured by progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR).

Key Dates

First listed
Aug 28, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Jul 1, 2029
Completion
Dec 1, 2033

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: R-DXd Alone or R-DXd Combined with Bevacizumab
    Participants will be randomized to receive either R-DXd, intravenously (IV), every 3 weeks (Q3W) alone, or R-DXd IV along with bevacizumab 15mg/kg, IV, Q3W, on Day 1 of each 21-day cycle, until radiological disease progression according to RECIST v1.1 as assessed by BICR, unacceptable toxicity or other protocol-specified discontinuation criteria are met.
  • Active Comparator: Arm 2: Bevacizumab Alone or Observation
    Participants will be randomized to receive either bevacizumab 15 mg/kg, IV, Q3W, or Investigator's choice of observation until radiological disease progression as assessed by BICR or unacceptable toxicity or until other protocol-specified discontinuation criteria are met.

Primary Outcome Measure

Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [ Time Frame: Up to approximately 6 years ]

Central Contacts

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