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 (RAINFOL-04)

June 1, 2026 updated by: Genmab

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

528

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Niigata, Japan
        • Recruiting
        • Niigata University Medical & Dental Hospital
      • Okayama, Japan
        • Recruiting
        • Okayama University Hospital
      • Tokyo, Japan
        • Recruiting
        • The Cancer Institute Hospital of JFCR
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Recruiting
        • Sapporo Medical University Hospital
      • Sapporo, Hokkaido, Japan
        • Recruiting
        • National Hospital Organization Hokkaido Cancer Center
    • Hyōgo
      • Akashi, Hyōgo, Japan
        • Recruiting
        • Hyogo Cancer Center
    • Mie-ken
      • Tsu, Mie-ken, Japan
        • Recruiting
        • Mie University Graduate School Of Medicine
    • Osaka
      • Takatsuki, Osaka, Japan
        • Recruiting
        • Osaka Medical and Pharmaceutical University Hospital
    • Saitama
      • Hidaka, Saitama, Japan
        • Recruiting
        • Saitama Medical University International Medical Center
  • United States
    • Florida
      • Miami, Florida, United States, 33140
        • Recruiting
        • Mt. Sinai Comprehensive Cancer Center
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Health Care System
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • Zangmeister Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.

Key Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rina-S + SOC
Participants will receive Rina-S and SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).
Drug: Bevacizumab
IV infusion
Drug: Rina-S
Intravenous (IV) infusion
Other Names:
  • PRO1184
  • GEN1184
  • Rinatabart sesutecan
Active Comparator: SOC
Participants will receive SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).
Drug: Bevacizumab
IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Up to approximately 4 years
Up to approximately 4 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 4 years
Up to approximately 4 years
PFS, per RECIST 1.1, as Determined by Blinded Independent Central Review
Time Frame: Up to approximately 3 years
Up to approximately 3 years
Second Determination of PFS (PFS2)
Time Frame: Up to approximately 4 years
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
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
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Collaborators

GOG Foundation

Investigators

  • Study Director: Study Official, Genmab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

November 4, 2025

First Submitted That Met QC Criteria

November 4, 2025

First Posted (Actual)

November 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCT1184-04
  • 2025-522167-15-00 (Ctis)
  • GOG-3134 (Other Identifier: Other Sponsor Identifier)
  • ENGOT-OV96 (Other Identifier: Other Sponsor Identifier)
  • jRCT2051250197 (Registry Identifier: Japan Registry for Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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