A Phase 3 Randomized Double-Blind Study of Pembrolizumab versus Placebo in Combination with Adjuvant Chemotherapy with or without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Carcinoma After Surgery with Curative Intent (MK3475 B21/ENGOT-en11/GOG-3053)
Brief description of study
The purpose of the study is to determine and compare pembrolizumab and adjuvant chemotherapy with placebo and adjuvant chemotherapy, with or without radiotherapy, in relation to survival. We want to know if pembrolizumab is superior to placebo in combination with adjuvant chemotherapy with or without radiotherapy. Pembrolizumab is an immunotherapy drug with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 andPD-L2.
Clinical Study Identifier: s20-01323
ClinicalTrials.gov Identifier: NCT04634877
Principal Investigator:
Bhavana Pothuri.
Other Investigators:
Whitfield B. Growdon,
Alexander A Hindenburg,
Todd J Carpenter,
Stella C Lymberis,
Peter B. Schiff,
Michelle Diane Swanson Lightfoot,
David Ebling,
Edna Shifteh,
Erin Annette Reese,
Jaime Lynn Moyles,
Edward A Jimenez,
Marina Stasenko,
Amanda Shepherd-Littlejohn,
Leslie R Boyd,
Fabia Brisard Pierrot,
Jonathan Haas,
Kelly A Levine,
Kent Chan,
Eva Chalas-Westermann,
Kathleen M Lutz,
Christina Grace Wilson,
Vania R. Baudin,
Deanna Gerber.
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