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A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Connecticut
Danbury Hospital
RECRUITING
Danbury
Wisconsin
ProHealth Care Inc
RECRUITING
Waukesha
Contact Information
Primary
Genmab Trial Information
clinicaltrials@genmab.com
+4570202728
Time Frame
Start Date: 2026-08-28
Estimated Completion Date: 2031-11
Participants
Target number of participants: 688
Treatments
Experimental: Arm 1: Rina-S ± Bevacizumab
Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
Active_comparator: Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab
Participants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.
Related Therapeutic Areas
Sponsors
Leads: Genmab

This content was sourced from clinicaltrials.gov

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