Spots Global Cancer Trial Database for Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma
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Trial Identification
Brief Title: Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma
Official Title: An Open-Label, Phase 1b, Multi-Arm Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Patients With Advanced Melanoma
Study ID: NCT02723006
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the initial safety profile and initial antitumor activity of the combination treatments (immune checkpoint inhibitors \[nivolumab, ipilimumab\] with investigational drugs \[TAK-580, TAK-202 (plozalizumab), vedolizumab\]) in the 3 arms when administered to participants with advanced melanoma.
Detailed Description: The drugs being tested in this study are called TAK-580, TAK-202 (plozalizumab), and vedolizumab. These investigational drugs were given along with standard of care checkpoint inhibitors (\[nivolumab in Arms 1 and 2\] or nivolumab + ipilimumab in Arm 3). This study looked at the safety profile of the combination treatments in each arm when administered to participants with metastatic melanoma. The study planned to enroll approximately 156 participants. Participants were assigned to one of the 3 treatment groups: * TAK-580 + nivolumab * TAK-202 (plozalizumab) + nivolumab * vedolizumab + nivolumab + ipilimumab This study consists of 3 parts. A dose-escalation safety lead-in phase, confirmatory safety phase and a cohort expansion phase. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 50 weeks. Participants may make multiple visits to the clinic and 30, 60, and 90 days after last dose of study drug for follow-up assessments.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, Tucson, Arizona, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
University of California San Francisco Medical Center, San Francisco, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Emory University Hospital, Atlanta, Georgia, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
New York University Langone Medical Center, New York, New York, United States
Saint Luke's Cancer Center - Bethlehem, Easton, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Inova Fairfax Hospital, Fairfax, Virginia, United States
Contact Details
Name: Medical Monitor
Affiliation: Millennium Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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