Spots Global Cancer Trial Database for Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours
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Trial Identification
Brief Title: Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours
Official Title: An Open-Label, Multicenter, Phase 1 Study of RP3 as a Single Agent and in Combination With PD-1 Blockade in Patients With Solid Tumors
Study ID: NCT04735978
Conditions
Study Description
Brief Summary: This is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP3 in adult participants with advanced solid tumors, to evaluate the safety and tolerability of RP3 both as a single agent and in combination with anti-PD1 therapy and to determine the recommended Phase 2 dose (RP2D) of RP3.
Detailed Description: RP3 is a genetically modified herpes simplex type 1 virus (HSV-1) that expresses exogenous genes (anti-CTLA-4 antibody, CD40 ligand and h4-1BBL) designed to directly destroy tumors and generate an anti-tumor immune response
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Iowa, Iowa City, Iowa, United States
University of Maryland, Baltimore, Maryland, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center, Houston, Texas, United States
Laboratoire de Recherche Translationnelle en Immunotherapie (LRTI), Gustave Roussy, Villejuif, , France
University of Athens, Athens, , Greece
University General Hospital Attikon, Athens, , Greece
Vall d'Hebron Hospital Hospital Universitario Vall d´Hebron (Vall d'Hebron University Hospital), Barcelona, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
START Madrid CIO Clara Campal, Hospital Universitario HM Sanchinarro Unidad de Ensayos Fase I Panta 3, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
The Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, Merseyside, United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Contact Details
Name: David Cohan, MD
Affiliation: Replimune Inc.
Role: STUDY_DIRECTOR
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