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)

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.

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: Ovarian Cancer; Platinum-sensitive Ovarian Cancer; PSOC
• Intervention / Treatment: Drug: Bevacizumab; Drug: Rina-S

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): 544
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Genmab Trial Information; Phone Number: +4570202728; Email: clinicaltrials@genmab.com

Study Locations

• Japan
  • Kashiwa, Japan
    • Recruiting
    • The Jikei University Kashiwa Hospital
  • Niigata, Japan
    • Recruiting
    • Niigata University Medical & Dental Hospital
  • Okayama, Japan
    • Recruiting
    • Okayama University Hospital
  • Sagamihara, Japan
    • Recruiting
    • Kitasato University Hospital
  • Tokyo, Japan
    • Recruiting
    • The Cancer Institute Hospital of JFCR
  • Yokohama, Japan
    • Recruiting
    • Kanagawa Prefectural Cancer Center
  • 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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 Blinded Independent Central Review (BICR)	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	Up to approximately 4 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Up to approximately 4 years
Second Determination of PFS (PFS2)	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	Up to approximately 4 years
Time to Deterioration (TTD) in the GHS/QoL Score Using the QLQ-C30	Up to approximately 4 years
PFS, per RECIST 1.1, as Determined by Investigator Assessment	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: Genmab
• Collaborators: GOG Foundation
• Investigators: Study Director: Study Official, Genmab

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): May 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): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab
• 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