Spots Global Cancer Trial Database for CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
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Trial Identification
Brief Title: CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma
Official Title: A Randomized, Open-label, Active-control, Phase 2/3 Study of First-line Intratumoral CMP-001 in Combination With Intravenous Nivolumab Compared to Nivolumab Monotherapy in Subjects With Unresectable or Metastatic Melanoma
Study ID: NCT04695977
Study Description
Brief Summary: CMP-001-011 is a Phase 2/3 study of CMP-001 intratumoral (IT) and nivolumab intravenous (IV) compared to nivolumab monotherapy administered to participants with unresectable or metastatic melanoma. The study is divided into two phases: Phase 2 and Phase 3. The primary objective of Phase 2 of the study is to determine confirmed objective response rate (ORR) for treatment with first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The secondary objective of Phase 2 of the study is to evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. The primary objective of Phase 3 of the study is to evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy for unresectable or metastatic melanoma. The secondary objectives of Phase 3 are to: * To evaluate the safety and tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma. * To evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic melanoma.
Detailed Description: Former Sponsor Checkmate Pharmaceuticals
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Moores Cancer Center at UC San Diego Health, La Jolla, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California, Los Angeles, Los Angeles, California, United States
USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California, United States
California Cancer Associates for Research & Excellence, Inc., San Marcos, California, United States
Hartford Healthcare, Hartford, Connecticut, United States
Cleveland Clinic, Weston, Florida, United States
University Cancer & Blood Center, Athens, Georgia, United States
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
University of Louisville Health Care, Louisville, Kentucky, United States
Atlantic Health, Morristown, New Jersey, United States
Duke University Cancer Institute, Durham, North Carolina, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center / Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Texas Oncology, Sammons Cancer Center, Dallas, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
West Virginia University, Morgantown, West Virginia, United States
Contact Details
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR
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