Rina-S plus standard care versus standard care as maintenance after second-line platinum chemotherapy for recurrent platinum-sensitive ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mt. Sinai Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• Sarasota Memorial Health Care System
  Sarasota, Florida, United States Recruiting
• Greater Baltimore Medical Center
  Towson, Maryland, United States Recruiting
• Missouri Cancer Associates
  Columbia, Missouri, United States Recruiting
• Methodist Estabrook Cancer Center
  Omaha, Nebraska, United States Recruiting
• Novant Health Presbyterian Medical Center
  Charlotte, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Genmab Trial Information
• Email: clinicaltrials@genmab.com
• Phone: +4570202728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.