A Phase 3 interventional study of Rina-S and Bevacizumab in Ovarian Cancer, sponsored by Genmab. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Genmab · Phase 3, Interventional, and Treatment
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.
This is a global, randomized, open-label, Phase 3 study of Rina-S + SOC (defined as either bevacizumab maintenance or no maintenance treatment [observation]) versus SOC as maintenance treatment in participants with newly diagnosed high-grade epithelial ovarian cancer who are not considered to be a candidate for poly (ADP-ribose) polymerase (PARP) inhibitor(s) (PARPi) maintenance therapy according to local SOC.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 602 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Genmab is the lead sponsor of 67 studies on the registry; 14 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 12 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Participants must meet one of the following criteria after completion of 1L platinum-based chemotherapy:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Participants will receive Rina-S + SOC. SOC consists of either bevacizumab maintenance or no maintenance treatment (observation).
Drug: Rina-S · Drug: Bevacizumab
Participants will receive SOC alone. SOC consists of either bevacizumab maintenance or no maintenance treatment (observation).
Drug: Bevacizumab
Intravenous (IV) infusion.
Also known as: Rinatabart sesutecan, GEN1184, PRO1184
IV infusion.
Progression-free Survival (PFS), per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, as Determined by Blinded Independent Central Review (BICR)
Time frame: Approximately 2 years
Overall Survival (OS)
Time frame: Approximately 4 years
PFS per RECIST v1.1, as Determined by Investigator Assessment
Time frame: Approximately 4 years
Progression-free Survival on the Next Line of Therapy after the First Progression (PFS2)
Time frame: Approximately 4 years
Time to First Subsequent Therapy (TFST)
Time frame: Approximately 4 years
Time to Second Subsequent Therapy (TSST)
Time frame: Approximately 4 years
Number of Participants with Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Time frame: Approximately 4 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs) Including Serious Adverse Events (SAEs) and Deaths
Time frame: Approximately 4 years
Overall Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Questionnaire
Time frame: Baseline up to approximately 4 years
Time to Deterioration (TTD) in the GHS/QoL Score using the EORTC QLQ C30 Questionnaire
Time frame: Baseline up to approximately 4 years
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Genmab