Rina-S plus standard care versus standard care as maintenance after second-line platinum chemotherapy for recurrent platinum-sensitive ovarian cancer
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 trial will test whether adding Rina-S to standard maintenance care helps people with recurrent platinum-sensitive ovarian cancer stay cancer-free longer after second-line platinum chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 528 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genmab Industry-sponsored |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 10 sites (Miami, Florida and 9 other locations) |
| Trial ID | NCT07225270 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label Phase 3 trial comparing Rina-S combined with standard of care versus standard of care alone as maintenance treatment after second-line platinum-based doublet chemotherapy in recurrent platinum-sensitive ovarian cancer. Standard of care may include bevacizumab or monitoring only, and no placebo is used. Up to about 528 participants will be enrolled across multiple countries, with randomization occurring within 8 weeks of the last dose of second-line platinum therapy. Treatment is given in 3-week cycles and can continue while the cancer remains controlled and side effects are acceptable, with regular clinic visits for monitoring and tests.
Who should consider this trial
Good fit: Adults with histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer that is platinum-sensitive (progression >6 months after prior platinum) who have completed second-line platinum doublet chemotherapy and are randomized within 8 weeks of their last dose are the intended participants.
Not a fit: Patients with platinum-resistant disease (progression ≤6 months after prior platinum), non-qualifying tumor histologies, or those who are medically unfit for maintenance therapy are unlikely to receive benefit from this trial.
Why it matters
Potential benefit: If successful, adding Rina-S could delay cancer recurrence and extend progression-free survival for people with recurrent platinum-sensitive ovarian cancer.
How similar studies have performed: Prior maintenance approaches using PARP inhibitors or bevacizumab have shown benefit in platinum-sensitive ovarian cancer, but Rina-S is a novel agent and has not yet been proven in phase 3.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida and 9 other locations
- Mt. Sinai Comprehensive Cancer Center — Miami, Florida, United States (Recruiting)
- Miami Valley Hospital South — Centerville, Ohio, 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)
Study contacts
- Study coordinator: Genmab Trial Information
- Email: clinicaltrials@genmab.com
- Phone: +4570202728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.