This Phase 3 study will be conducted in different countries around the world with up to about 528 participants. The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer. Participants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also 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 weeks). 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) for each participant will be different for every participant.
This is a randomized, open-label, Phase 3 study of Rina-S + standard of care (SOC) versus SOC as maintenance treatment after second-line (2L) platinum-based doublet chemotherapy in participants with recurrent PSOC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
528
Intravenous (IV) infusion
IV infusion
Mt. Sinai Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGOsaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
RECRUITINGProgression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by Investigator Assessment
Time frame: Up to approximately 3 years
Overall Survival
Time frame: Up to approximately 4 years
PFS, per RECIST 1.1, as Determined by Blinded Independent Central Review
Time frame: Up to approximately 3 years
Second Determination of PFS (PFS2)
Time frame: Up to approximately 4 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 4 years
Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Questionnaire
Time frame: Up to approximately 4 years
Time to Deterioration (TTD) in the GHS/QoL Score Using the Quality of Life Questionnaire Core 30 Questionnaire
Time frame: Up to approximately 4 years
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