This Phase 3 study will be conducted in different countries around the world with up to approximately 602 participants.
The purpose of this study is to evaluate how well Rina-S alone or in combination with an approved, standard of care (SOC) treatment works against ovarian cancer (including primary peritoneal or fallopian tube cancer) compared to the same available SOC therapy by itself, or no treatment (only monitoring).
On average, the expected trial duration for an individual participant will be approximately 4 years (depending on treatment received). The treatment length and follow-up duration will be different for every participant, but an average of 16 months of treatment is expected, followed by an estimated 29-month post treatment follow up period.
Participation in the study will require visits to the study site(s). Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 weeks). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the trial treatment is safe and effective. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep receiving trial treatment for the protocol-defined study duration.
Newly diagnosed, histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III, or IV high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube carcinoma.
Participants must have received 6 cycles of 1L-platinum-based chemotherapy, in accordance with applicable clinical guidelines. Up to 8 cycles are permitted based on local clinical practice.
Participants not deemed candidates for surgery or who have completed planned cytoreductive surgery (either primary debulking surgery [PDS] or IDS) are eligible.
Participants who received platinum-based chemotherapy with bevacizumab must have achieved complete response (CR)/no clinical evidence of disease (NED), partial response (PR), or stable disease (SD), as assessed by the investigator, and be eligible to continue bevacizumab maintenance.
Participant has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.
Participant has received any intervening systemic anticancer treatment excluding bevacizumab or a biosimilar administered as part of 1L treatment after the last dose of 1L platinum-based chemotherapy and before randomization.
Participant with any previous treatment with PARPi.
Participants with previous therapy with other anti-angiogenic agents different from bevacizumab or biosimilar.
Parallel
Rina-S
DrugIntravenous (IV) infusion.
Bevacizumab
DrugIV infusion.
Progression-free Survival (PFS), per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, as Determined by Blinded Independent Central Review (BICR)
Overall Survival (OS)
PFS per RECIST v1.1, as Determined by Investigator Assessment
Progression-free Survival on the Next Line of Therapy after the First Progression (PFS2)
Time to First Subsequent Therapy (TFST)
This trial is not recruiting at the moment. You can still explore other options:
