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New treatment for relapsed high-grade serous ovarian cancer

A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Relapsed After Prior Platinum-based Chemotherapy

Phase1; Phase2 Interventional Merck Sharp & Dohme LLC · NCT06843447

This study is testing a new drug combined with standard treatments to see if it can help people with relapsed high-grade serous ovarian cancer feel better and manage their disease.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment460 (estimated)
Ages18 Years and up
SexFemale
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionsbevacizumab, radiation, Chemotherapy
Locations17 sites (Louisville, Kentucky and 16 other locations)
Trial IDNCT06843447 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the safety and efficacy of Raludotatug Deruxtecan, an antibody drug conjugate, in combination with standard treatments like Carboplatin, Paclitaxel, and Bevacizumab for patients with relapsed high-grade serous ovarian cancer. The study aims to determine how well this new treatment works alongside existing therapies and whether patients can tolerate the combination. Participants will be monitored for measurable disease progression and overall response to the treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals with a documented diagnosis of high-grade serous ovarian cancer who have experienced relapse after 1 to 3 prior lines of therapy.

Not a fit: Patients with non-serous ovarian cancer types or those who have not had prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed high-grade serous ovarian cancer.

How similar studies have performed: Other studies using antibody drug conjugates have shown promise in treating various cancers, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Has pathologically documented diagnosis of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
* Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1
* Participants in Cohort A-1 Arms 2 and 3: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease)
* Participants in Cohort B-1 and Cohort B-2: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression \<6 months (\<180 days) after the last dose of platinum-based therapy (ie, platinum-resistant disease). Participants must have received no more than 1 prior bevacizumab-containing systemic treatment regimen
* Participants in Cohort B-1 and Cohort B-2: Is a candidate for bevacizumab treatment
* Has provided tumor tissue from a core or excisional biopsy of a tumor lesion not previously irradiated
* Has an Eastern Cooperative Oncology Group performance status of 0 to 1 assessed within 7 days before allocation/randomization
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy
* Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation/randomization
* Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
* Participants in Cohort C-1 and Cohort D: Has relapsed disease after 1 prior line of therapy, radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease) and progressed during prior treatment with PARPi in the first-line setting
* Cohort A-2 Arms 1, 2, and 3: Has relapsed disease after 1 prior line of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease)

Exclusion Criteria:

* Has any of the following within 6 months before allocation/randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event
* 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, and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement, or prior pneumonectomy
* Has ≥Grade 2 peripheral neuropathy
* Has received prior treatment with cadherin-6-targeted agents
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before allocation
* Has received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Receives chronic steroid treatment
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active CNS metastases and/or carcinomatous meningitis
* Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of prior steroid use, current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening
* Has active infection requiring systemic therapy
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Where this trial is running

Louisville, Kentucky and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian Cancer Recurrent
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.