A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy
Genmab
Summary
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).
Description
This is a global, open-label, randomized Phase 3 study in approximately 660 participants with recurrent or progressive EC following prior therapy. Participants will be randomized in a 1:1 ratio to receive treatment with Rina-S vs investigator's choice (IC) (paclitaxel or doxorubicin). Investigators must select one of the IC treatment options for each participant prior to randomization so that this may be used for treatment assignment if the participant is randomized to the IC arm.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Key Inclusion Criteria * Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy. * Participants must have received at least 1, but not more than 3, prior lines of therapy: * Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination * If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, ad…
Interventions
- DrugRina-S
Intravenous (IV) infusion.
- DrugIC
* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion
Locations (74)
- MedStar Washington HospitalWashington D.C., District of Columbia
- SMH - Sarasota - Main CampusSarasota, Florida
- Women's Care - 9th AveSt. Petersburg, Florida
- Emory Winship Cancer Inst.Atlanta, Georgia
- Emory Winship Cancer Inst.Atlanta, Georgia
- Emory Winship Cancer Inst./Emory Decatur HospitalDecatur, Georgia