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

NCT07225270 | Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: GCT1184-042025-522167-15-00jRCT2051250197GOG-3134ENGOT-OV96
• Study Type: interventional
• Target: 528
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Ovarian Cancer; PSOC; Platinum-sensitive Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by Investigator Assessment

  Up to approximately 3 years

Secondary Outcomes (6)

• Overall Survival

  Up to approximately 4 years

• PFS, per RECIST 1.1, as Determined by Blinded Independent Central Review

  Up to approximately 3 years

• Second Determination of PFS (PFS2)

  Up to approximately 4 years

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  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

Study Arms (2)

Rina-S + SOC

EXPERIMENTAL

Participants will receive Rina-S and SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).

Drug: Rina-S; Drug: Bevacizumab

SOC

ACTIVE COMPARATOR

Participants will receive SOC consisting of either bevacizumab maintenance or no maintenance treatment (observation).

Drug: Bevacizumab

Interventions

Rina-S DRUG

Intravenous (IV) infusion

Also known as: Rinatabart sesutecan, GEN1184, PRO1184

Rina-S + SOC

Bevacizumab DRUG

IV infusion

Rina-S + SOC; SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genmab: lead

Study Sites (10)

Mt. Sinai Comprehensive Cancer Center

Miami, Florida, 33140, United States

RECRUITING

Miami Valley Hospital South

Centerville, Ohio, 45459, United States

RECRUITING

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

RECRUITING

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

RECRUITING

Hyogo Cancer Center

Akashi, Hyōgo, Japan

RECRUITING

Mie University Graduate School Of Medicine

Tsu, Mie-ken, Japan

RECRUITING

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Osaka, Japan

RECRUITING

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

RECRUITING

Niigata University Medical & Dental Hospital

Niigata, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Central Study Contacts

Genmab Trial Information

CONTACT

+4570202728; clinicaltrials@genmab.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 6, 2025
• Study Start: April 3, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (8); US (2)