NCT06619236

Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (estimated)
• Sponsor: Genmab · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 3 study will be conducted in different countries all over the world. The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer. Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose. All participants will receive active drug; no one will be given placebo.

Conditions

• Platinum-resistant Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Rina-S	Intravenous (IV) infusion
DRUG	Paclitaxel	IV infusion
DRUG	Topotecan	IV infusion
DRUG	Pegylated liposomal doxorubicin (PLD)	IV infusion
DRUG	Gemcitabine	IV infusion

Timeline

• Start date: 2025-02-07
• Primary completion: 2027-02-01
• Completion: 2028-05-23
• First posted: 2024-10-01
• Last updated: 2026-03-03

Locations

177 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, China, Czechia, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Norway, Poland, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study