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Brief Title: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)
Official Title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)
Study ID: NCT05116202
Brief Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
The Angeles Clinic and Research Institute - W LA Office, Los Angeles, California, United States
Providence St Johns Health Center, Santa Monica, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
MD Anderson Cancer Center, Houston, Texas, United States
Melanoma Institute Australia, North Sydney, New South Wales, Australia
Linear Clinical Research Limited, Nedlands, Western Australia, Australia
Hopital de la Timone, Marseille, , France
APHP - Hospital Saint Louis, Paris, , France
Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Azienda Ospedaliera Universitaria Senese, Siena, Abruzzo, Italy
Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Istituto Europeo Di Oncologia, Milano, Lombardia, Italy
Ospedale S.Maria della Misericordia, Perugia, Umbria, Italy
Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands
Leids Universitair Medisch Centrum, Leiden, , Netherlands
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitario Vall d Hebron, Barcelona, , Spain
Clinica Universidad de Navarra ; Servicio de Farmacia, Madrid, , Spain
Hospital Universitario HM Sanchinarro-CIOCC, Madrid, , Spain
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR