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

NCT07791732 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 7 other identifiers: DS6000-1692025-522715-41-00GOG-3138192-OENGOT-ov104jRCT20312603462025
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

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

Keywords

Primary Peritoneal Cancer; Ovarian Cancer; Fallopian Tube Cancer; Raludotatug Deruxtecan (R-DXd); Cadherin 6 (CDH6)

Outcome Measures

Primary Outcomes (1)

• 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)

  PFS is defined as the time (month) from the date of randomization to the earlier date of the first objective documentation of radiographic disease progression as assessed by BICR per RECIST v1.1 or death due to any cause.

  Up to approximately 6 years

Secondary Outcomes (16)

• Overall Survival (OS)

  Up to approximately 6 years

• PFS as Assessed by Investigator per RECIST v1.1

  Up to approximately 6 years

• Progression Free Survival 2 (PFS2)

  Up to approximately 6 years

• Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

  Up to approximately 6 years

• Plasma Concentrations of R-DXd (Conjugated Antibody)

  Pre-dose and post-dose at multiple timepoints during each cycle, up to approximately 6 years (Cycle length=21 days)

Study Arms (2)

Arm 1: R-DXd Alone or R-DXd Combined with Bevacizumab

EXPERIMENTAL

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.

Drug: R-DXd; Drug: Bevacizumab

Arm 2: Bevacizumab Alone or Observation

ACTIVE COMPARATOR

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.

Drug: Bevacizumab

Interventions

R-DXd DRUG

R-DXd will be administered as an intravenous (IV) infusion.

Also known as: DS-6000a

Arm 1: R-DXd Alone or R-DXd Combined with Bevacizumab

Bevacizumab DRUG

Bevacizumab will be administered as an IV infusion.

Also known as: AVASTIN®, MVASI

Arm 1: R-DXd Alone or R-DXd Combined with Bevacizumab; Arm 2: Bevacizumab Alone or Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants with assigned female sex at birth.
• Participants with histologically or cytologically documented high-grade (Grade 3) serous or endometrioid epithelial ovarian cancer (OVC), primary peritoneal cancer, or fallopian tube cancer.
• Has an homologous recombinant deficiency (HRD) or breast cancer gene (BRCA) test result using a validated or approved test as per applicable regulations available.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Required baseline local laboratory data (within 7 days prior to randomization) as specified in the protocol.
• A woman of childbearing potential (WOCBP), as specified in the protocol, is eligible to participate if the protocol-specified conditions are met.
• Must have received 2 prior lines of platinum-based therapy:
• For the first-line (1L) platinum-based chemotherapy (penultimate, platinum-based course prior to enrollment on the trial), must have platinum-sensitive disease after this treatment, defined as documented radiologic disease progression assessed by the investigator (evident measurable or non-measurable disease according to RECIST v1.1) \>6 months following the last dose of the platinum administered.
• For the second (last) platinum-based chemotherapy course prior to enrollment on the trial, must have received a platinum-containing regimen for a minimum of 4 cycles and a maximum of 8 cycles.
• Must have achieved evidence of non-progressive radiological disease based on investigator-assessed RECIST 1.1 and CA-125 at the end of induction treatment with platinum-based doublet chemotherapy (no evidence of disease \[NED\], complete response \[CR\], partial response \[PR\] or stable disease \[SD\] for participants with measurable disease at baseline; or NED, CR, or non-CR/non-progressive disease \[PD\] for participants with non-measurable disease based on RECIST v1.1).
• According to investigator assessment, polymerase inhibitor (PARPi) as 2L maintenance treatment is not the preferred option for the participant.
• Must be randomized between 4 and 9 weeks after completion of their final dose of the platinum-containing regimen.
• Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other trial procedures, and trial restrictions.

You may not qualify if:

• Non-serous or non-endometrioid high-grade epithelial histology, or non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) or low-grade/borderline OVC.
• Inadequate washout period before randomization, defined as follows:
• Major surgery less than (\<)28 days.
• Radiation therapy less than equal to (≤)28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days).
• Systemic anticancer therapy (including but not limited to antibody-drug therapy, retinoid therapy, and hormonal therapy) \<28 days or 5 half-lives, whichever is shorter, before starting trial intervention or current participation in other therapeutic investigational procedures.
• Chloroquine/hydroxychloroquine ≤14 days.
• Exposure to another investigational trial intervention within 28 days prior to start of trial intervention or current participation in other therapeutic investigational procedures.
• Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Participants with untreated and asymptomatic brain metastases or participants with previously treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the trial if they have recovered from the acute toxic effect of radiotherapy, at the investigator's discretion. A minimum of 2 weeks must have elapsed between the end of radiotherapy and trial intervention and there should be no evidence of progression or need for steroids treatment or anticonvulsants for at least 2 weeks prior to randomization.
• Any of the following within the past 6 months prior to randomization: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event (e.g., intestinal ischemia).
• Uncontrolled or significant cardiovascular disease:
• QTcF interval \>470 milliseconds (ms).
• Diagnosed or suspected long QT syndrome.
• History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.
• Participant has clinically relevant bradycardia of less than 50 beats per minute (bpm), unless the participant has a pacemaker.
• History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Daiichi Sankyo Contact for Clinical Trial Information

CONTACT

9089926400; CTRinfo_us@daiichisankyo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 1, 2033
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Completed studies that have reached a global end or completion with all data set collected and analyzed, and for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents on completed clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.