Recruiting
Phase 3

R-DXd & Bevacizumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07776691

Conditions

Ovarian Cancer

Ovarian Neoplasms

Peritoneal Cancer

Fallopian Tube Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

R-DXd

Bevacizumab

Study Details

Brief summary:

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.

Conditions

Ovarian Cancer

Ovarian Neoplasms

Peritoneal Cancer

Fallopian Tube Cancer

Study ID

NCT07776691

Start date

Sep 18, 2026

Status verified date

Nov, 2026

Completion date

Oct 22, 2034

Anticipated

Primary completion date

Mar 19, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

802 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: R-DXd with or without bevacizumab

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.

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

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.

Interventions

R-DXd

R-DXd administered as an intravenously (IV) infusion

Bevacizumab

Administered as an intravenously IV infusion

Primary outcome measure

  • Progression-Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 5.5 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

MedStar Washington Hospital Center ( Site 0026)

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Study Coordinator

202-877-9386

Lahey Hospital & Medical Center ( Site 0031)

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Study Coordinator

781-744-3421

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000)

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Study Coordinator

541-683-5001

Texas Oncology - West Texas ( Site 8009)

Recruiting

Amarillo, Texas, United States, 79124

Contacts

Study Coordinator

325-692-0188

Texas Oncology - Central/South Texas ( Site 8002)

Recruiting

Austin, Texas, United States, 78731

Contacts

Study Coordinator

512-427-9400

Texas Oncology - DFW ( Site 8005)

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-413-1500

Texas Oncology - Northeast Texas ( Site 8004)

Recruiting

Tyler, Texas, United States, 75702

Contacts

Study Coordinator

903-535-4688

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.