Spots Global Cancer Trial Database for Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)
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Trial Identification
Brief Title: Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)
Official Title: A Phase 1/2 Open-label Rolling-arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02A
Study ID: NCT04305041
Conditions
Study Description
Brief Summary: Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. As of Amendment 4 (effective date: 05JAN2022), a third arm has been opened to participant enrollment, treatment with pembrolizumab and all-trans retinoic acid (ATRA). Enrollment into the first two arms, treatment with pembrolizumab + quavonlimab+ vibostolimab and treatment with pembrolizumab + quavonlimab + lenvatinib has been completed per protocol as of September 2021.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Angeles Clinic and Research Institute ( Site 1009), Los Angeles, California, United States
UCLA Hematology & Oncology ( Site 1004), Los Angeles, California, United States
Providence Saint John's Health Center ( Site 1010), Santa Monica, California, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 1012), Aurora, Colorado, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022), Baltimore, Maryland, United States
NYU Clinical Cancer Center ( Site 1002), New York, New York, United States
Duke Cancer Institute ( Site 1005), Durham, North Carolina, United States
Martha Morehouse Tower ( Site 1020), Columbus, Ohio, United States
Oregon Health & Science University ( Site 1013), Portland, Oregon, United States
University of Pennsylvania Abramson Cancer Center ( Site 1008), Philadelphia, Pennsylvania, United States
West Cancer Center - East Campus ( Site 1014), Germantown, Tennessee, United States
University of Texas MD Anderson Cancer Center ( Site 1006), Houston, Texas, United States
Inova Schar Cancer Institute ( Site 1011), Fairfax, Virginia, United States
Calvary Mater Newcastle-Medical Oncology ( Site 1404), Waratah, New South Wales, Australia
Melanoma Institute Australia ( Site 1402), Wollstonecraft, New South Wales, Australia
Tasman Oncology Research Pty Ltd ( Site 1403), Southport, Queensland, Australia
Fiona Stanley Hospital ( Site 1401), Murdoch, Western Australia, Australia
Hopital La Timone ( Site 1103), Marseille, Bouches-du-Rhone, France
Hopital Saint Andre ( Site 1108), Bordeaux, Gironde, France
Institut Claudius Regaud ( Site 1105), Toulouse cedex 9, Haute-Garonne, France
Gustave Roussy ( Site 1101), Villejuif, Ile-de-France, France
Centre Hospitalier Lyon Sud ( Site 1102), Pierre Benite, Rhone, France
A.P.H. Paris, Hopital Saint Louis ( Site 1107), Paris, , France
HaEmek Medical Center ( Site 1703), Afula, , Israel
Rambam Health Care Campus-Oncology ( Site 1704), Haifa, , Israel
Hadassah Ein Karem Jerusalem ( Site 1702), Jerusalem, , Israel
Chaim Sheba Medical Center ( Site 1701), Ramat Gan, , Israel
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1399), Milano, , Italy
Istituto Europeo di Oncologia ( Site 1301), Milano, , Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 1302), Napoli, , Italy
Istituto Oncologico Veneto IRCCS ( Site 1355), Padova, , Italy
Policlinico Le Scotte - A.O. Senese ( Site 1377), Siena, , Italy
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1603), Genève, Geneve, Switzerland
CHUV Centre Hospitalier Universitaire Vaudois ( Site 1602), Lausanne, Vaud, Switzerland
Universitaetsspital Zuerich ( Site 1601), Zuerich Flughafen, Zurich, Switzerland
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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