New treatment for relapsed high-grade serous ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has pathologically documented diagnosis of high-grade serous or high-grade endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
* Participants in Part 1 cohorts and Part 2 Cohort A-2 Arms 1, 2, and 3, Cohort B-2, and Cohort C-2 Arm 3: 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, Cohort B-2, Cohort C-2 Arm 3, Cohort E-1 and if administering bevacizumab is planned in Cohort D or Cohort A-2 Arms 1, 2, or 3: Is a candidate for bevacizumab treatment
* Has provided tumor tissue for biomarker research (all cohorts)
* Has an Eastern Cooperative Oncology Group performance status of 0 to 1
* Participants in Cohort C-1, Cohort C-2 Arm 3, Cohort D, and Cohort E-1: 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 poly-ADP ribose polymerase inhibitor (PARPi) in the first-line setting
* Participants in 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)
* Participants in Cohort C-2 Arms 1 and 2: Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics Stage III or Stage IV epithelial ovarian cancer (high-grade serous or high-grade endometrioid), fallopian tube cancer, or primary peritoneal cancer that is non-homologous recombination deficiency-positive
* Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, PARPi first-line maintenance treatment for non- homologous recombination deficiency (HRD)-positive disease is not the preferred option for the participant
* Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, bevacizumab treatment for non-HRD-positive disease is not the preferred option for the participant

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 it's running

• Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)
  New Haven, Connecticut, United States Recruiting
• The University of Louisville, James Graham Brown Cancer Center ( Site 0009)
  Louisville, Kentucky, United States Recruiting
• TRIALS 365 ( Site 0020)
  Shreveport, Louisiana, United States Recruiting
• Dana-Farber Cancer Institute ( Site 0015)
  Boston, Massachusetts, United States Recruiting
• Memorial Sloan Kettering Cancer Center ( Site 0003)
  New York, New York, United States Recruiting
• OU Health University of Oklahoma Medical Center ( Site 7000)
  Oklahoma City, Oklahoma, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment for platinum-resistant recurrent ovarian cancer using IN10018 and PLD

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• Using SBRT and Niraparib for Ovarian Cancer with Limited Progression

  This study is testing if combining a type of targeted radiation therapy with a cancer medication can help women with advanced ovarian cancer that has only spread a little bit feel better and live longer.

  Recruiting at 7 sites Phase 2 Institute of Cancer Research, United Kingdom · Leeds, Leeds and 6 other locations · NCT05990192

• Surgery and Niraparib for recurrent ovarian cancer

  This study is testing whether surgery followed by chemotherapy and a drug called Niraparib can help people with recurrent ovarian cancer do better than just chemotherapy alone.

  Recruiting Phase 2 Shanghai Gynecologic Oncology Group · Shanghai, Shanghai Municipality and 4 other locations · NCT03983226

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.