NCT07564141 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
| NCT ID | NCT07564141 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Genmab |
| Condition | Platinum-Sensitive Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 688 participants |
| Start Date | 2026-08-28 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 688 participants in total. It began in 2026-08-28 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Study Official
STUDY DIRECTOR
Genmab
Frequently Asked Questions
Who can join the NCT07564141 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Platinum-Sensitive Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07564141 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 688 participants.
Is NCT07564141 currently recruiting?
Yes, NCT07564141 is actively recruiting participants. Contact the research team at clinicaltrials@genmab.com for enrollment information.
Where is the NCT07564141 trial being conducted?
This trial is being conducted at Danbury, United States, Waukesha, United States.
Who is sponsoring the NCT07564141 clinical trial?
NCT07564141 is sponsored by Genmab. The principal investigator is Study Official at Genmab. The trial plans to enroll 688 participants.
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