Study of Rinatabart Sesutecan vs Treatment of Investigator’s Choice in Patients with Ovarian Cancer
Research type
Research Study
Full title
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
IRAS ID
1010348
Contact name
Christina Strate-Nielsen
Contact email
Sponsor organisation
Genmab A/S
Eudract number
2024-514822-21
Clinicaltrials.gov Identifier
Research summary
This phase 3 study will be conducted in different countries all over the world with approximately 530 participants.
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 approved chemotherapy agents that are considered standard medical care. These are paclitaxel, topotecan, pegylated liposomal doxorubicin (PLD), or gemcitabine. 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.
The study duration will be up to 3 years. All participants will receive an active drug; no one will be given placebo. Treatment can continue as long as the participant is gaining clinical benefit, provided that they are not experiencing unacceptable side-effects.REC name
Wales REC 1
REC reference
25/WA/0042
Date of REC Opinion
8 Apr 2025
REC opinion
Further Information Favourable Opinion