Spots Global Cancer Trial Database for A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
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Trial Identification
Brief Title: A Substudy of Investigational Agents in Programmed Cell Death-1/Ligand 1 (PD-1/L1) Refractory Locally Advanced or Metastatic Urothelial Carcinoma (mUC) (MK-3475-04A)
Official Title: A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents With or Without Pembrolizumab in Participants With PD-1/L1 Refractory Locally Advanced or Metastatic Urothelial Carcinoma (KEYMAKER-U04): Substudy 04A
Study ID: NCT05562830
Conditions
Interventions
Study Description
Brief Summary: This substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. Substudy 04A will enroll participants with locally advanced or mUC whose disease is resistant to treatment with programmed cell death-1/ligand 1 (PD-1/L1) inhibitors. The protocol infrastructure will enable the rolling assignment of investigational treatments.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 1045), Orange, California, United States
Anschutz Cancer Pavilion ( Site 1017), Aurora, Colorado, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 1011), Indianapolis, Indiana, United States
Washington University ( Site 1038), Saint Louis, Missouri, United States
Cleveland Clinic-Taussig Cancer Center ( Site 1036), Cleveland, Ohio, United States
UPMC Hillman Cancer Center ( Site 1014), Pittsburgh, Pennsylvania, United States
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si, Brisbane, Queensland, Australia
FALP-UIDO ( Site 1151), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 1155), Santiago, Region M. De Santiago, Chile
Rigshospitalet-Dept. of Oncology ( Site 1701), Copenhagen, Hovedstaden, Denmark
Rambam Health Care Campus-Oncology ( Site 1501), Haifa, , Israel
Rabin Medical Center-Oncology ( Site 1504), Petah Tikva, , Israel
Sheba Medical Center-ONCOLOGY ( Site 1503), Ramat Gan, , Israel
Severance Hospital, Yonsei University Health System ( Site 1903), Seoul, , Korea, Republic of
Asan Medical Center ( Site 1901), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 1902), Seoul, , Korea, Republic of
Hospital Universitari Vall d'Hebron ( Site 1767), Barcelona, , Spain
Hospital Clinico San Carlos ( Site 1765), Madrid, , Spain
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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