Spots Global Cancer Trial Database for A Phase 1B/2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies
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Trial Identification
Brief Title: A Phase 1B/2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies
Official Title: An Open-Label, Multicenter, Phase 1B/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients With Advanced Cutaneous Malignancies
Study ID: NCT04349436
Interventions
Study Description
Brief Summary: This Phase 1B/2 study is a multicenter, open-label, study of RP1 to investigate the (a) objective response rate, in addition to (b) safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients. This will include patients with either previous renal, hepatic, heart, lung, or other solid organ transplantation or hematopoietic cell transplant and experiencing subsequent documented locally advanced or metastatic cutaneous malignancies. The study will enroll a total of 65 evaluable patients. Patients will participate up to approximately 3 years including a 28-day screening period, up to approximately 1 year treatment period, and a 2-year follow-up period.
Detailed Description: RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1B/2, open label, multicenter, trial evaluating the objective response rate and the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 in adult hepatic, renal, heart, lung, other solid organs, or hematopoietic cell transplant recipients who subsequently experienced advanced or metastatic cutaneous malignancies. Patients will be dosed with RP1 by direct or ultrasound guided intra-tumoral injection into superficial, subcutaneous or nodal tumors. No transplanted organs will be injected.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medical Dermatology Specialists, Phoenix, Arizona, United States
University of California, San Diego, La Jolla, California, United States
University of California, Los Angeles, Los Angeles, California, United States
UCSF, Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
University of Colorado Cancer Center School of Medicine, Aurora, Colorado, United States
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
University of Chicago, Chicago, Illinois, United States
University of Michigan, Ann Arbor, Michigan, United States
Columbia University Medical Center, New York, New York, United States
Rochester Dermatologic Surgery, New York, New York, United States
Duke University, Durham, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
VCU Massey Cancer Center, Richmond, Virginia, United States
Contact Details
Name: Jeannie Hou, MD
Affiliation: Replimune Inc.
Role: STUDY_DIRECTOR
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