Ovarian CancerPhase 3RAINFOL-04NCT07225270
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
A Phase 3 study testing Rina-S and Bevacizumab in people with Ovarian Cancer and Platinum-sensitive Ovarian Cancer, run by Genmab at 34 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Platinum-sensitive Ovarian Cancer, PSOC
- 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
- 544 participants
- Where
- 34 sitesin 8 countries
- Study dates
- 3 Apr 2026to May 2030
- 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
- 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 primary (first-line [1L]) platinum therapy.
- Participants with known breast cancer (BRCA)-mutated (somatic or germline) or homologous recombination deficiency (HRD)-positive ovarian cancer who achieved complete response (CR)/no clinical evidence of disease (NED) or partial response (PR) following 1L platinum-based chemotherapy regimen must have previously received PARPi maintenance therapy as part of their 1L treatment.
- Must have completed platinum-based chemotherapy in the 2L treatment for recurrent PSOC.
- Must be randomized no later than 8 weeks from the last dose of the 2L platinum-based therapy.
- Participants must have achieved a CR/NED, PR; or SD permitted only if bevacizumab was given in 2L in combination with platinum-based chemotherapy, as assessed by the investigator, following completion of 2L platinum-based chemotherapy.
Who cannot join
- Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors
- More than 2 prior lines of systemic therapy.
- Progression while on or following 2L platinum-based regimen prior to randomization.
- Participants who receive an intervening systemic anticancer treatment (excluding bevacizumab) after the last dose of 2L platinum-based chemotherapy and prior to randomization.
- Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Trial locations and contacts
34 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 8 countries
Japan16 sites, 16 recruiting
- Recruiting
Hyogo Cancer Center
Akashi, Hyōgo
- Recruiting
Saitama Medical University International Medical Center
Hidaka, Saitama
- Recruiting
The Jikei University Kashiwa Hospital
Kashiwa
- Recruiting
St Marianna University School of Medicine
Kawasaki
- Recruiting
Kurume University Hospital
Kurume
- Recruiting
Shizuoka Cancer Center
Nagaizumi-chō
- Recruiting
Niigata University Medical & Dental Hospital
Niigata
- Recruiting
Okayama University Hospital
Okayama
- Recruiting
Kitasato University Hospital
Sagamihara
- Recruiting
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido
- Recruiting
Sapporo Medical University Hospital
Sapporo, Hokkaido
- Recruiting
Tohoku University Hospital
Sendai
- Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka
- Recruiting
The Cancer Institute Hospital of JFCR
Tokyo
- Recruiting
Mie University Graduate School Of Medicine
Tsu, Mie-ken
- Recruiting
Kanagawa Prefectural Cancer Center
Yokohama
United States9 sites, 9 recruiting
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
- Recruiting
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
- Recruiting
Missouri Cancer Associates
Columbia, Missouri, 65201
- Recruiting
Zangmeister Cancer Center
Columbus, Ohio, 43219
- Recruiting
Alliance Cancer Specialists - Abington Hematology Oncology Associates - Horsham
Horsham, Pennsylvania, 19044
- Recruiting
Mt. Sinai Comprehensive Cancer Center
Miami, Florida, 33140
- Recruiting
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114
- Recruiting
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
- Recruiting
Greater Baltimore Medical Center
Towson, Maryland, 21204
Belgium3 sites, 3 recruiting
- Recruiting
UZ Leuven - Gasthuisberg Campus
Leuven
- Recruiting
AZ Delta - Uw Ziekenhuis
Roeselare
- Recruiting
AZ Nikolaas
Sint-Niklaas
France2 sites, 2 recruiting
- Recruiting
Hôpital Privé du Confluent
Nantes
- Recruiting
Hôpital René Huguenin
Saint-Cloud
Poland1 site, 1 recruiting
- Recruiting
Białostockie Centrum Onkologii im. M. Skłodowskiej-Curie w Białymstoku
Bialystok
Spain1 site, 1 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña
About this study
Official title: 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)
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.
Read more
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.
Read the 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.
- Conditions
- Ovarian Cancer, Platinum-sensitive Ovarian Cancer, PSOC
- Being tested
- Rina-S, Bevacizumab
- Medical subject headings
- Ovarian 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 and SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation). Receives: Drug: Rina-S; Drug: Bevacizumab |
| SOC | Active comparator | Participants will receive SOC consisting 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 Tumours (RECIST) 1.1, as Determined by Blinded Independent Central Review (BICR)
Measured: Up to approximately 3 years
Secondary outcomes (6)
Overall Survival
Measured: Up to approximately 4 years
PFS, per RECIST 1.1, as Determined by Investigator Assessment
Measured: Up to approximately 3 years
Second Determination of PFS (PFS2)
Measured: Up to approximately 4 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: 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
Measured: Up to approximately 4 years
Time to Deterioration (TTD) in the GHS/QoL Score Using the QLQ-C30
Measured: 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 posted6 Nov 2025
- Study start3 Apr 2026
- Primary completionOct 2028 (estimated)
- Study completionMay 2030 (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
- 544 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
- NCT07225270
- Sponsor's protocol ID
- GCT1184-04
- Other IDs
- 2025-522167-15-00, jRCT2051250197, GOG-3134, ENGOT-OV96, 2025
- Acronym
- RAINFOL-04
- Status last verified
- Oct 2026
- First submitted
- 4 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No