Inhibrx Biosciences, Inc
This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.
Head and Neck Squamous Cell Carcinoma (HNSCC)
INBRX-106
Pembrolizumab
PHASE2
PHASE3
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 410 participants |
Masking : | DOUBLE |
Masking Description : | Phase 2: open label; Phase 3: double-blind |
Primary Purpose : | TREATMENT |
Official Title : | A Phase 2/3, Randomized Study of INBRX-106 Combined With Pembrolizumab Versus Pembrolizumab as First Line Treatment for Patients With Recurrent or Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Expressing PD-L1 (CPS ≥20) (HexAgon-HN) |
Actual Study Start Date : | 2024-05-14 |
Estimated Primary Completion Date : | 2029-05 |
Estimated Study Completion Date : | 2029-05 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
City of Hope Medical Center
Duarte, California, United States, 91010
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Los Angeles Cancer Network (LACN)
Los Angeles, California, United States, 91204
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Sutter Health
Sacramento, California, United States, 95816
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UC Davis
Sacramento, California, United States, 95817
RECRUITING
Medical Oncology Associates of San Diego
San Diego, California, United States, 92123
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Sarcoma Oncology Center
Santa Monica, California, United States, 90403
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ChristianaCare Health Services
Newark, Delaware, United States, 19713
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The Oncology Institute of Hope & Innovation
Miami, Florida, United States, 33169
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Mid Florida Hematology and Oncology Center
Orange City, Florida, United States, 32763
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Cleveland Clinic Florida, The Maroone Cancer Center
Weston, Florida, United States, 33331
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University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
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Norton Cancer Institute
Louisville, Kentucky, United States, 40202
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Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
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Karmanos Cancer Institute
Detroit, Road cancer, United States, 48201
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Washington University St. Louis
Saint Louis, Missouri, United States, 63110
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Intermountain Health, St. Vincent Regional Hospital, Cancer Centers of Montana
Billings, Montana, United States, 59102
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Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
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Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
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Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States, 87505
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UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599-7305
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Oklahoma University Stephenson Cancer Center
Ololama City, Okholohan, United States, 73104
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Oregon Health & Science University
Portland, Oregon, United States, 97239
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
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CHRISTUS Spohn Cancer Center
Corpus Christi, Texas, United States, 78404
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VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
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Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
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University Hospital Brussels
Throw, Belgium, 1090
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CHU UCL Namur Sainte-Elisabeth Site
Namur, Belgium, 5000
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Vitaz
Sint-Niklaas, Belgium, 9100
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Uneos-Hopital R.Schuman
Metz, Moselle, France, 57000
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Center Leon Berard
Lyon, France, 69008
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European Institute of Oncology
Milan, Italy, 20141
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IRCCS Policlinico San Matteo Foundation
Pavia, Italy, 27100
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Pusan National University Yang Hospital
The, Gyeongsangnam-do, Korea, Republic of, 50612
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Gachon University Gil Medical Center of Korea
Seoul, Incheon, Korea, Republic of, 21565
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Keimyung University Dongsan Hospital of Korea
Daegu, Korea, Republic of, 42601
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Korea Cancer Center Hospital
Seoul, Korea, Republic of, 01812
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Korea University Anam Hospital
Seoul, Korea, Republic of, 02841
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Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
RECRUITING
Korea University Teacher Hospital
Seoul, Korea, Republic of, 08308
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University of Science Malaysia Hospital
Kubang kerian, Kelantan, Malaysia, 16150
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Sarawak General Hospital
Kuching, Sarawak, Malaysia, 93586
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Hospital Chancellor Tuanku Muhriz (HCTM) UKM
Cheras, Federal Territory of Kuala Lumpur, Malaysia, 56000
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National Cancer Institute
Putrajaya, Malaysia, 62250
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Comedy medical clinic
Konin, Poland, 62-500
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Proven Profamilia
Piotrków Trybunalski, Poland, 97-300
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SC oncolab etc.
Craiova, Dolj, Romania, 200385
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SC SF NECTARIE SRL oncology Center
Craiova, Dolj, Romania, 200745
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ARENSIA Clinic Oncology Institute Bucharest
Bucharest, Romania, 022328
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Arensia Exploratory Medicine S.R.L in collaboration with "Prof. Dr. Ion Chiricuta" Oncology Institute
Cluj-Napoca, Cluj, Romania, 400015
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Catalan Institute of Oncology
Barcelona, Catalonia, Spain, 08908
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IOB / Institute of Oncology, Quirónsalud Barcelona Hospital
Barcelona, Gracia, Spain, 08023
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Navarra University Hospital
Pamplona, Navarra, Spain, 31008
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Clinic Hospital in Barcelona
Barcelona, Spain, 08036
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UNIVERSITY HOSPITAL COMPLEX A CORUÑA
Coruña, Spain, 15006
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MD Anderson Cancer Centre
Madrid, Spain, 28033
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La Fe University and Polytechnic Hospital
Valencia, Spain,
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Taipei Veterans General Hospital
Taipei City, Beitou District / R.o.c., Taiwan, 11217
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Taichung Veterans General Hospital
Taichung, China, Taiwan, 407219
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National Taiwan University Hospital
Taipei City, Taiwan, 100226
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The Royal Marsden NHS Foundation Trust, Chelsea
Chelsea, London, United Kingdom, Juice
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The Royal Marsden NHS Foundation Trust, Sutton
Suton, Surrey, United Kingdom, Cm25pT
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NHS Grampian / Aberdeen Royal Infirmary
Aberdeen, United Kingdom, I am a brother
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Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ