Recruiting
Phase 3

R-DXd & Bevacizumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07743164

Conditions

Ovarian Cancer

Peritoneal Cancer

Fallopian Tube Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

R-DXd

Bevacizumab

Carboplatin

Paclitaxel

Gemcitabine

Study Details

Brief summary:

Researchers are looking for new ways to treat advanced, high-grade ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body (metastatic) and may not be removed with surgery. High-grade means the cancer cells grow and spread quickly. This trial includes types of OC that started in cells that cover the ovaries, in the lining of the belly, or in the fallopian tubes.

The usual treatment for high-grade OC may include one or both of these:

  • Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing.
  • Bevacizumab, which is a targeted therapy that works to control how specific types of cancer cells grow and spread and targets tumor blood vessels.

Researchers want to learn about the trial medicine, raludotatug deruxtecan (also called R-DXd or MK-5909), when given with and without bevacizumab and how participants respond to it. R-DXd is an antibody drug conjugate (ADC). An ADC is a type of medicine that attaches to a specific target on cancer cells and delivers treatment to destroy those cells.

The goals of this trial are to learn if participants who receive R-DXd, with or without bevacizumab, live longer overall and without their cancer growing or spreading compared to those who receive usual treatment.

Conditions

Ovarian Cancer

Peritoneal Cancer

Fallopian Tube Cancer

Study ID

NCT07743164

Start date

Oct 7, 2026

Status verified date

Oct, 2026

Completion date

Aug 31, 2031

Anticipated

Primary completion date

Aug 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

  • Has a histologically or cytologically documented advanced high-grade serous or high-grade endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • Has received 1 line of platinum-based therapy with a minimum of 4 cycles of platinum-doublet chemotherapy and have platinum-sensitive disease.
  • Has received a poly (ADP-ribose) polymerase inhibitor (PARPi) as maintenance treatment after the first line platinum-based chemotherapy course and experienced radiographic progression during treatment or within 42 days of the last dose of PARPi.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization.
  • Has recovered from any AEs due to previous anticancer therapies.

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

  • Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline ovarian cancer.
  • Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active GI bleeding within 6 months before randomization.
  • Has uncontrolled or significant cardiovascular disease.
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of randomization, severe asthma, severe chronic obstructive pulmonary disease \[COPD\], restrictive lung disease, pleural effusion) and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), or prior pneumonectomy.
  • Has received chronic steroid treatment, with some exceptions.
  • Has current, clinically relevant bowel obstruction (including subocclusive disease) including obstruction related to underlying epithelial ovarian cancer, abdominal fistula or GI perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years.

Study Design

Enrollment

646 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: R-DXd +/- 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: Standard of Care

Participants receive 6 to 8 cycles of investigator's choice of one of three options of platinum-based chemotherapy with or without IV bevacizumab. Bevacizumab treatment if elected, will continue until PD, unacceptable toxicity, or other protocol specified reason for discontinuation

Interventions

R-DXd

R-DXd alone or in combination with bevacizumab administered via IV infusion

Bevacizumab

Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w

Carboplatin

Carboplatin area under the curve (AUC) 5 mg/mL\*min or AUC 4 mg/mL\*min administered on day 1 q3w for a maximum of 8 cycles

Paclitaxel

Paclitaxel 175 mg/m\^2 administered via IV infusion on day 1 q3w for a maximum of 8 cycles

Gemcitabine

Gemcitabine 1000 mg/mL administered via IV infusion on day 1 and day 8 of each 3-week cycle for a maximum of 8 cycles

Pegylated liposomal doxorubicin (PLD)

PLD 30 mg/m\^2 administered via IV infusion on day 1 of each 4-week cycles for a maximum of 8 cycles

Primary outcome measure

  • Progression-free Survival (PFS) [ Time Frame: Up to approximately 3 years ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 4 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

MemorialCare Orange Coast Medical Center ( Site 0032)

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Study Coordinator

562-972-8625

Orlando Health Cancer Institute ( Site 0018)

Recruiting

Orlando, Florida, United States, 32806

Contacts

Study Coordinator

321-841-1869

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.