Rina-S with or without bevacizumab after platinum therapy for recurrent platinum-sensitive 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 global, open-label Phase 3 study randomizes participants to receive Rina-S alone or with bevacizumab, versus the investigator's choice platinum-based chemotherapy with or without bevacizumab as second-line treatment. Eligible patients have high-grade serous or endometrioid ovarian cancer that recurred after first-line platinum therapy and remains platinum-sensitive. The study compares safety and efficacy across treatment arms, with treatment continued as long as disease remains controlled and tolerable. No placebo is used; two arms compare Rina-S strategies to standard-of-care chemotherapy options. Key endpoints include response, progression-free survival, and overall safety in a diverse international population.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.
* Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, \>183 days) after their last dose administration of platinum-based therapy.
* Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.
* Participants must have measurable disease per RECIST v1.1 by investigator at baseline.
* All participants must provide a tumor specimen.
* Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.

Key Exclusion Criteria:

* Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.
* Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.
* Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.
* Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα).

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Danbury Hospital
  Danbury, Connecticut, United States Recruiting
• Compass Oncology - West Cancer Center (Northwest Cancer Specialists, P.C.)
  Tigard, Oregon, United States Recruiting
• Alliance Cancer Specialists, PC
  Bensalem, Pennsylvania, United States Recruiting
• Utah Cancer Specialists
  South Jordan, Utah, United States Recruiting
• West Virginia University
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Study coordinator: Genmab Trial Information
• Email: clinicaltrials@genmab.com
• Phone: +4570202728

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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.