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 530 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
2027-02
Completion
2028-05-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified Intravenous
Comparator Gemcitabine Small molecule Intravenous
Comparator Paclitaxel Small molecule Intravenous
Subject Rina-S Unknown Intravenous
Comparator Topotecan Small molecule Intravenous