Ovarian CancerPhase 3RAINFOL™-10NCT07859215
Study to Assess the Efficacy and Safety of Rina-S Plus Standard of Care Compared to Standard of Care Maintenance Treatment After First-line (1L) Platinum-based Chemotherapy in Participants With Ovarian Cancer
A Phase 3 study testing Rina-S and Bevacizumab in people with Ovarian Cancer, run by Genmab.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Rina-S and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 602 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jul 2034
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 must meet one of the following criteria after completion of 1L platinum-based chemotherapy:
- 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.
- Participants who received platinum-based chemotherapy without bevacizumab must have achieved CR/NED or PR, as assessed by the investigator, and be considered appropriate for observation.
- Trial intervention must start within 3 to 12 weeks of the last dose of front-line chemotherapy. To avoid a treatment-free interval, bevacizumab administration should continue following the final platinum dose, provided the participant remains eligible through screening and up to the point of randomization, and no contraindications exist.
Who cannot join
- 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.
- Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase 1 inhibitor.
- Participant has received prior therapy with ADC targeting folate receptor alpha (FRα).
- Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment in Participants With Ovarian Cancer Following First-Line (1L) Platinum-Based Chemotherapy
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Ovarian Cancer
- Being tested
- Rina-S, Bevacizumab
- Keywords
- Ovarian Cancer, Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Rinatabart Sesutecan, Rina-S, Antibody-drug Conjugate, Maintenance Treatment, Bevacizumab, Folate Receptor Alpha
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rina-SDrug
Also called Rinatabart sesutecan, GEN1184, PRO1184
Intravenous (IV) infusion.
BevacizumabDrug
IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Rina-S + SOC | Experimental | Participants will receive Rina-S + SOC. SOC consists of either bevacizumab maintenance or no maintenance treatment (observation). Receives: Drug: Rina-S; Drug: Bevacizumab |
| SOC | Active comparator | Participants will receive SOC alone. SOC consists of either bevacizumab maintenance or no maintenance treatment (observation). Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS), per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, as Determined by Blinded Independent Central Review (BICR)
Measured: Approximately 2 years
Secondary outcomes (9)
Overall Survival (OS)
Measured: Approximately 4 years
PFS per RECIST v1.1, as Determined by Investigator Assessment
Measured: Approximately 4 years
Progression-free Survival on the Next Line of Therapy after the First Progression (PFS2)
Measured: Approximately 4 years
Time to First Subsequent Therapy (TFST)
Measured: Approximately 4 years
Time to Second Subsequent Therapy (TSST)
Measured: Approximately 4 years
Number of Participants with Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
Measured: Approximately 4 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs) Including Serious Adverse Events (SAEs) and Deaths
Measured: 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
Measured: Baseline up to approximately 4 years
Time to Deterioration (TTD) in the GHS/QoL Score using the EORTC QLQ C30 Questionnaire
Measured: Baseline up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionJul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 602 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859215
- Sponsor's protocol ID
- GCT1184-10
- Other IDs
- 2026-525683-18-00, GOG-3153, ENGOT-ov111
- Acronym
- RAINFOL™-10
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No