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)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Ovarian Neoplasms; Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: Bevacizumab; Biological: R-DXd

Study type: Interventional

Funder types: Industry

Identifiers

NCT07776691

U1111-1331-2704 (Registry Identifier)

2025-524592-22-00 (Registry Identifier)

5909-006

2025

Details and patient eligibility

About

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:

Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.

Observation, which is watching to see if cancer grows or worsens. The study medicine, raludotatug deruxtecan- R-DXd, is a targeted therapy. The goal of this study is to learn if people who receive R-DXd maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

Enrollment: 802 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV epithelial ovarian cancer (EOC) (high grade serous or high grade endometrioid), fallopian tube cancer, or primary peritoneal cancer
• Has undergone primary debulking surgery (PDS) or interval debulking surgery (IDS)
• Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol
• Has provided tumor tissue that is not previously irradiated
• Who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except alopecia or vitiligo), as assessed by the physician investigator
• Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• Has non-serous or non-endometrioid high-grade epithelial histology, nonepithelial ovarian cancers, borderline tumors, mucinous tumor, seromucinous tumor that is predominately mucinous, malignant Brenner's tumor, and undifferentiated carcinoma
• Has received 1L platinum-based chemotherapy without bevacizumab and have a response of SD or PR at the time of screening
• Has received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria
• Has not recovered from major surgery or has ongoing surgical complications
• Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
• Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder or prior pneumonectomy
• Has current, clinically relevant bowel obstruction including obstruction related to underlying EOC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam
• HIV-infected participants with a history of Kaposi's sarcoma and/or multicentric Castleman disease
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has active infection requiring systemic therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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802 participants in 2 patient groups

Arm 1: R-DXd with or without bevacizumab

Experimental group

Description:

Participants will receive intravenous (IV) raludotatug deruxtecan (R-DXd)with or without IV bevacizumab for up to 2 years until progressive disease (PD), unacceptable toxicity, or other protocol-specified reason for discontinuation.

Treatment:

Biological: R-DXd

Drug: Bevacizumab

Arm 2: Standard of care (bevacizumab or observation only)

Active Comparator group

Description:

Participants will receive bevacizumab 15 mg/kg IV q3w for up to 22 cycles (each cycle=21 days) until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention or will be observed and actively followed if not receiving bevacizumab.

Treatment:

Drug: Bevacizumab