Spots Global Cancer Trial Database for Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN
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Trial Identification
Brief Title: Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN
Official Title: A Phase 2, Open-label, Multicenter Study Investigating Oncolytic Immunotherapy in Combination With Other Therapy in Patients With Locoregionally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT05743270
Study Description
Brief Summary: This is a Phase 2, multicenter, open-label, 2-cohort (Locoregionally Advanced Cohort or Recurrent/Metastatic Cohort) study evaluating RP3 in combination with concurrent chemoradiation therapy (CCRT) followed by nivolumab (for the LA Cohort) or combined with chemotherapy and nivolumab (for the R/M Cohort) in patients with advanced, inoperable squamous cell carcinomas of the head and neck (SCCHN), including of the oral cavity, oropharynx, hypopharynx, larynx, or unknown primary.
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 kill tumor cells and generate a systemic anti-tumor immune response
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego, UCSD, La Jolla, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA Medicine Division of Hematology-Oncology, Los Angeles, California, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Thomas Jefferson University City Center and Abington, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, UPMC, Pittsburgh, Pennsylvania, United States
Jefferson Health Abington Asplunhd Cancer Pavillion, Willow Grove, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
University of Washington / Fred Hutchinson Cancer Center, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
University Hospital Olomouc, Olomouc, , Czechia
Fakultni Thomayerova Nemocnice, Prague, , Czechia
FN Kralovske Vinohrady, Praha, , Czechia
Centre Georges Francois Leclerc, Department of Oncology, Dijon, , France
Centre Leon Berard, Lyon, , France
Assistance Publique Hopitaux De Marseille, Marseille, , France
CHU Nimes, Instiut de Cancerologie du Gard, Medical Oncology, Nîmes, , France
Institut Gustave Roussy Paris, Villejuif, , France
Charite University Hospital of Berlin, Comprehensive Cancer Center, Berlin, , Germany
Universitatsklinik Jena Klinik und Poliklinik fur Hals-, Nasen - und Ohrenheilkunde, Jena, , Germany
University Hospital Leipzig Clinic and Polyclinic for otorhinolaryngology, Leipzig, , Germany
LMU Klinikum, Medizinische Klinik und Poliklinikum III, Munich, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
University General Hospital Attikon, Chaïdári, , Greece
Agios Lukas Hospital, Thessaloníki, , Greece
Szpital Specjalistyczny im Ludwika Rydygiera w Krakowie sp z oo, Department of Clinical Oncology, Kraków, , Poland
Vall d'Hebron University Hospital, Vall d' Hebron Institute of Oncology (VHIO), Barcelona, , Spain
La Paz Univeristy Hospital, Universidad Autonoma de Madrid, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Clinica Universitaria de Navarra, Pamplona, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
Contact Details
Name: David Cohan, MD/FACS
Affiliation: Replimune Inc.
Role: STUDY_DIRECTOR
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