Spots Global Cancer Trial Database for Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
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Trial Identification
Brief Title: Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
Official Title: An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors
Study ID: NCT03767348
Study Description
Brief Summary: RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
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 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent RP1, an expansion phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Birmingham Alabama, Birmingham, Alabama, United States
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic, Phoenix, Arizona, United States
Carti Cancer Center, Little Rock, Arkansas, United States
UC San Diego, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
UCLA, Los Angeles, California, United States
University of California, Irvine, Orange, California, United States
University of California- San Francisco, San Francisco, California, United States
Sylvester Comprehensive Cancer Center- University of Miami, Miami, Florida, United States
University of Iowa-Cancer Center Research, Iowa City, Iowa, United States
James Graham Brown Cancer Center- University of Louisville, Louisville, Kentucky, United States
Mayo Clinic, Rochester, Minnesota, United States
Atlantic Health System, Morristown, New Jersey, United States
New York University Clinical Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Duke Cancer Center, Durham, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
MUSC Health, Charleston, South Carolina, United States
West Cancer Center, Germantown, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Eccles Outpatient Care Center- Oncology Clinical Trials, Murray, Utah, United States
Intermountain Cancer Center- Saint George Cancer Center, Saint George, Utah, United States
Seattle Cancer Care Alliance- University of Washington, Seattle, Washington, United States
University of Wisconsin-Carbone Cancer Center, Madison, Wisconsin, United States
CHU Besancon - Hopital Jean Minjoz, Besançon, , France
Institut Bergonié, Bordeaux, , France
CHU Dijon, Dijon, , France
Centre Léon Bérard Lyon, Lyon, , France
Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone, Marseille, , France
CHU de Nice Hôpital l'Archet, Nice, , France
Hôpital Saint Louis APHP, Paris, , France
Institut Gustave Roussy, Villejuif, , France
Charité (Campus Benjamin Franklin), Berlin, , Germany
University Hospital Essen, Klinik für Dermatologie, Essen, , Germany
University of Kiel (UKSH), Dep. of Dermatology, Kiel, , Germany
Uniklinik Marburg, Marburg, , Germany
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Institut Catala D'Oncologia - Hospital Duran I, Barcelona, , Spain
Clínica Universidad de Navarra (Madrid), Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca, Murcia, , Spain
Clinica Universitaria de Navarra, Pamplona, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital General Universitario de Valencia, Valencia, , Spain
University of Leeds- Teaching Hospital, Leeds, England, United Kingdom
Oxford University Hospitals NHS Trust, Oxford, Oxfordshire, United Kingdom
Beatson West of Scotland Cancer Center, Glasgow, Scotland, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Wirral, United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Contact Details
Name: Jeannie Hou, MD
Affiliation: Replimune Inc.
Role: STUDY_DIRECTOR
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