Spots Global Cancer Trial Database for Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
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Trial Identification
Brief Title: Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
Official Title: Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Select Solid Tumors
Study ID: NCT04291105
Study Description
Brief Summary: This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment.
Detailed Description: Patients enrolled into three parallel doublet cohorts with an optimal Simon's two stage design. Patients will receive Voyager V1 as a direct to tumor injection (IT) in all 3 cancer groups and cemiplimab via IV infusion. Patients will return for treatment every 3 weeks until lack of clinical benefit or limiting toxicity. Efficacy evaluations will be conducted every 6 weeks.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinical, Phoenix, Arizona, United States
City of Hope Medical Center, Duarte, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
HOAG Memorial Hospital Presbyterian, Newport Beach, California, United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI), Santa Monica, California, United States
Stanford Health Care, Stanford, California, United States
Yale University, New Haven, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Mayo Clinical, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Billings Clinic Montana Cancer Consortium, Billings, Montana, United States
Atlantic Health, Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Ohio State University, Columbus, Ohio, United States
UPMC, Pittsburgh, Pennsylvania, United States
Sanford Cancer Center, Sioux Falls, South Dakota, United States
UT Health San Antonio MD Anderson Cancer Center, San Antonio, Texas, United States
INCA, Rio De Janeiro, RJ, Brazil
Hospital Moinhos de Vento, Porto Alegre, RS, Brazil
Hospital de Amor de Barretos, Barretos, SP, Brazil
Contact Details
Name: Alice Bexon, MD
Affiliation: CMO
Role: STUDY_CHAIR
Name: Stephen J Russell, MD, Ph.D.
Affiliation: Clinical Lead
Role: STUDY_DIRECTOR
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