Spots Global Cancer Trial Database for Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)
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Trial Identification
Brief Title: Study of Intratumoral (IT) Ulevostinag (MK-1454) in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)
Official Title: A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination With IV Pembrolizumab vs IV Pembrolizumab Monotherapy
Study ID: NCT04220866
Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). The primary study hypotheses are that IT ulevostinag in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone: 1. In participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and 2. In participants with a tumor that has a PD-L1 CPS ≥ 20.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Hematology & Oncology ( Site 0005), Los Angeles, California, United States
University of California at San Francisco ( Site 0006), San Francisco, California, United States
Henry Ford Hospital ( Site 0012), Detroit, Michigan, United States
Washington University ( Site 0021), Saint Louis, Missouri, United States
Sanford Cancer Center Oncology Clinic ( Site 0014), Sioux Falls, South Dakota, United States
Huntsman Cancer Institute ( Site 0004), Salt Lake City, Utah, United States
Chris OBrien Lifehouse ( Site 0040), Camperdown, New South Wales, Australia
Calvary Central Districts Hospital ( Site 0042), Elizabeth Vale, South Australia, Australia
Monash Health-Monash Medical Centre ( Site 0041), Clayton, Victoria, Australia
Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 0051), Linz, Oberosterreich, Austria
Allgemeines Krankenhaus der Stadt Wien ( Site 0049), Vienna/Wien, Wien, Austria
SCRI-CCCIT GesmbH ( Site 0050), Salzburg, , Austria
Centro Regional Integrado de Oncologia ( Site 0062), Fortaleza, Ceara, Brazil
Hospital de Caridade de Ijui ( Site 0061), Ijui, Rio Grande Do Sul, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0058), Sao Paulo, , Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0064), Sao Paulo, , Brazil
Centre Antoine Lacassagne ( Site 0070), Nice, Alpes-Maritimes, France
Centre Leon Berard ( Site 0072), Lyon, Auvergne, France
IUCT - Oncopole ( Site 0069), Toulouse, Haute-Garonne, France
Centre Oscar Lambret ( Site 0071), Lille, Nord, France
Gustave Roussy ( Site 0068), Villejuif, Val-de-Marne, France
Chaim Sheba Medical Center ( Site 0076), Ramat Gan, Tel Aviv, Israel
Rambam Medical Center ( Site 0077), Haifa, , Israel
Hadassah Medical Center. Ein Kerem ( Site 0078), Jerusalem, , Israel
Severance Hospital ( Site 0103), Seoul, , Korea, Republic of
Asan Medical Center ( Site 0104), Seoul, , Korea, Republic of
Haukeland Universitetssykehus, Klinisk forskningspost voksne ( Site 0086), Bergen, Hordaland, Norway
Oslo Universitetssykehus Radiumhospitalet ( Site 0085), Oslo, , Norway
H.U. Vall de Hebron ( Site 0112), Barcelona, , Spain
Hospital Clinico de Barcelona ( Site 0116), Barcelona, , Spain
Hospital Universitario Ramon y Cajal ( Site 0115), Madrid, , Spain
Hospital Universitario Virgen de la Victoria ( Site 0114), Malaga, , Spain
Royal Marsden NHS Foundation Trust ( Site 0031), London, London, City Of, United Kingdom
Royal Marsden Hospital Sutton-Surrey ( Site 0032), Sutton, Surrey, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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