Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care for Maintenance Treatment of Participants With Recurrent Platinum-sensitive Ovarian Cancer After Second-line (2L) Platinum-based Doublet Chemotherapy
Recruiting
Phase 3
Interventional Study
Ovarian Cancer
Platinum-sensitive Ovarian Cancer
PSOC
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 544 (estimated)
- Sponsor
- Genmab · Industry
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About This Trial
This Phase 3 study will be conducted in different countries around the world with up to about 544 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, b…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Must have histologically or cytologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
* Must have PSOC defined as progressive disease \> 6 months (ie, 183 days) from the last dose of prim…
Contacts