Spots Global Cancer Trial Database for Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma
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Trial Identification
Brief Title: Navtemadlin (KRT-232) With or Without Anti-PD-1/Anti-PD-L1 for the Treatment of Patients With Merkel Cell Carcinoma
Official Title: A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients With p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination With Avelumab in MCC Patients Who Are Anti-PD-1 or Anti-PD-L1 Treatment Naïve
Study ID: NCT03787602
Conditions
Study Description
Brief Summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Merkel Cell Carcinoma (MCC) who have failed treatment with at least one anti-PD-1 or anti-PD-L1 immunotherapy or in combination with avelumab in MCC patients who are anti-PD-1 or anti-PD-L1 treatment naïve. Inhibition of MDM2 is a novel mechanism of action in MCC.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
Miami Cancer Institute, Miami, Florida, United States
Moffitt, Tampa, Florida, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Norton Healthcare, Louisville, Kentucky, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Mount Sinai Hospital, New York, New York, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson, Houston, Texas, United States
Inova Health Care Services, Fairfax, Virginia, United States
Princess Alexandra Hospital Oncology, Woolloongabba, , Australia
Centro Catarinense de Pesquisa (CECAP) - Hospital Santa Catarina de Blumenau, Blumenau, , Brazil
Instituto Nacional do Cancer, Brasília, , Brazil
Centro Intergado de Oncologia, Curitiba, , Brazil
Centro de Pesquisa Clinica em Oncologia, Ijuí, , Brazil
Clinica De Neoplasias Litoral, Itajai, , Brazil
Hospital Paulistano, São Paulo, , Brazil
Princess Margaret Cancer Centre, Toronto, , Canada
CHU de Bordeaux- Hopital Saint-Andre, Bordeaux, , France
AP-HP Universite Paris Saclay, Gif-sur-Yvette, , France
CHU de Lille, Lille, , France
CHU Lyon-Sud, Lyon, , France
Hôpital de la Timone. Aix-Marseille Université, Marseille, , France
CHU Montpellier, Montpellier, , France
CHU de Nantes, Nantes, , France
Hôpital Saint Louis - APHP, Paris, , France
CHU de Tours, Tours, , France
Vivantes Network for Health Gmb, Neukölln Clinic, Berlin, , Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
Universitätsklinikum Essen (AöR), Essen, , Germany
Nationales Centrum für Tumorerkrankungen NCT, Heidelberg, , Germany
Uniklinik Koln, Köln, , Germany
Universitätsklinik Rostock, Rostock, , Germany
Universitats-Hautklinik Tubingen, Tübingen, , Germany
Institute for Cancer Research and Treatment, Candiolo, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, , Italy
AUSL della Romagna, Ravenna, , Italy
AOUS Le Scotte, Siena, , Italy
OSP Civile Maggiore Borgo Trento, Verona, , Italy
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
University Medical Center Groningen, Groningen, , Netherlands
Hospital Duran i Reynals, Barcelona, , Spain
Hospital General Universitario Gregorio Marañn (Madrid), Madrid, , Spain
Complejo Hospitalario de Navarra, Pamplona, , Spain
Fundacio Investigao Hospital General Universitario de Valencia, Valencia, , Spain
Contact Details
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