A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)
Summary
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.
Detailed description
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.
Arms & interventions
- DrugRina-S
Intravenous (IV) infusion
- DrugBevacizumab
IV infusion
Outcome measures
Primary
Progression-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
Secondary
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 QLQ-C30
Time frame: Up to approximately 4 years
Eligibility criteria
Study locations (4)
Mt. Sinai Comprehensive Cancer Center
Miami, Florida, 33140
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Miami Valley Hospital South
Centerville, Ohio, 45459
Zangmeister Cancer Center
Columbus, Ohio, 43219