Spots Global Cancer Trial Database for A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
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Trial Identification
Brief Title: A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
Official Title: A Phase l/ll Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-CD27 Antibody (Varlilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
Study ID: NCT02335918
Interventions
Study Description
Brief Summary: This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and nivolumab (also known as Opdivo® , BMS-936558). Both drugs target the immune system and may act to promote anti-cancer effects.
Detailed Description: Varlilumab is a fully human monoclonal antibody that binds to a molecule called CD27 found on certain immune cells and may act to promote anti-tumor effects. Nivolumab is a fully human monoclonal antibody that binds to a molecule called PD-1 on immune cells and promotes anti-tumor effects. Eligible patients that enroll in the dose escalation portion of the study will be assigned to one of three dose levels of varlilumab in combination with 3 mg/kg of nivolumab. The first phase of the study will test the safety profile of the combination and determine which dose will be studied in Phase ll of the overall study. During Phase ll, depending on cancer type, groups of patients will be enrolled and receive varlilumab at a dose of either 3 mg/kg every 2 weeks, 3 mg/kg every 12 weeks, or 0.3 mg/kg every 4 weeks in combination with nivolumab at 240 mg. All patients enrolled in the study will be closely monitored to determine if there is response to the treatment as well as for any side effects that may occur.
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
The Stanford Center for Clinical and Translational Education and Research, Palo Alto, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
University of Colorado Medical Center, Aurora, Colorado, United States
Smilow Cancer Hospital at Yale University Cancer Center, New Haven, Connecticut, United States
Georgetown University, Washington, District of Columbia, United States
George Washington University School of Medicine and Health Sciences, Washington, District of Columbia, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Northwest Georgia Oncology Centers PC, Marietta, Georgia, United States
Parkview Research Center, Fort Wayne, Indiana, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Providence Health & Services, Portland, Oregon, United States
Inova Schar Cancer Institute Research, Fairfax, Virginia, United States
Contact Details
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