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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 · Genmab
In plain English

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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)
About this study
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.
Eligibility criteria
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 design
Enrollment target: 544 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-03
Estimated completion: 2030-05
Last updated: 2026-07-16
Interventions
Drug: Rina-SDrug: Bevacizumab
Primary outcomes
  • 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)
Sponsor
Genmab · industry
Contacts & investigators
ContactGenmab Trial Information · contact · clinicaltrials@genmab.com · +4570202728
InvestigatorStudy Official · study_director, Genmab
All locations (16)
Mt. Sinai Comprehensive Cancer CenterRecruiting
Miami, Florida, United States
Sarasota Memorial Health Care SystemRecruiting
Sarasota, Florida, United States
Miami Valley Hospital SouthRecruiting
Centerville, Ohio, United States
Zangmeister Cancer CenterRecruiting
Columbus, Ohio, United States
National Hospital Organization Hokkaido Cancer CenterRecruiting
Sapporo, Hokkaido, Japan
Sapporo Medical University HospitalRecruiting
Sapporo, Hokkaido, Japan
Hyogo Cancer CenterRecruiting
Akashi, Hyōgo, Japan
Mie University Graduate School Of MedicineRecruiting
Tsu, Mie-ken, Japan
Osaka Medical and Pharmaceutical University HospitalRecruiting
Takatsuki, Osaka, Japan
Saitama Medical University International Medical CenterRecruiting
Hidaka, Saitama, Japan
The Jikei University Kashiwa HospitalRecruiting
Kashiwa, Japan
Niigata University Medical & Dental HospitalRecruiting
Niigata, Japan
Okayama University HospitalRecruiting
Okayama, Japan
Kitasato University HospitalRecruiting
Sagamihara, Japan
The Cancer Institute Hospital of JFCRRecruiting
Tokyo, Japan
Kanagawa Prefectural Cancer CenterRecruiting
Yokohama, Japan
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 · TrialPath