N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer

Sponsor: Genmab • ClinicalTrials.gov ID: NCT07564141

Registry updated: 2026-10-07
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

This Phase 3 study will be conducted in different countries around the world with up to about 688 participants. The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab. Participants will receive either: * Rina-S monotherapy (by itself), * Rina-S plus bevacizumab, * investigator's choice chemotherapy (by itself) (standard of care), or * investigator's choice chemotherapy plus bevacizumab (standard of care). No participants will be given placebo. Participants will participate in 1 of 2 arms. The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

Interventions

  • Rina-S (Biological)
    Intravenous (IV) infusion
  • Bevacizumab (Drug)
    IV infusion
  • Carboplatin (Drug)
    IV infusion
  • Gemcitabine (Drug)
    IV infusion
  • Paclitaxel (Drug)
    IV infusion
  • PLD (Drug)
    IV infusion

Eligibility criteria

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.

Conditions

Platinum-Sensitive Ovarian Cancer Ovarian Cancer

Locations

  • City of Hope — Duarte, California, United States
  • Danbury Hospital — Danbury, Connecticut, United States
  • Compass Oncology - West Cancer Center (Northwest Cancer Specialists, P.C.) — Tigard, Oregon, United States
  • Alliance Cancer Specialists, PC — Bensalem, Pennsylvania, United States
  • West Virginia University — Morgantown, West Virginia, United States
  • ProHealth Care Inc — Waukesha, Wisconsin, United States
  • The Cancer Institute Hospital of JFCR — Tokyo, Koto City, Japan
  • Niigata Cancer Center Hospital — Chuo Ku Niigata, Niigata, Japan
  • Yamagata University Hospital — Yamagata, Yamagata, Japan
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record