drugset / Trial / NCT06619236

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

NCT06619236 ↗

Phase 3 Active not recruiting 584 enrolled Genmab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-02-07
Primary completion
2026-08-18
Completion
2027-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule — Intravenous
Comparator Paclitaxel Small molecule — Intravenous
Comparator Pegylated liposomal doxorubicin Unknown — Intravenous
Subject Rina-S Other / unclassified — Intravenous
Comparator Topotecan Small molecule — Intravenous