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ACTIVE NOT RECRUITING
NCT06295731
PHASE2/PHASE3

INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC

Sponsor: Inhibrx Biosciences, Inc

View on ClinicalTrials.gov

Summary

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

410

Start Date

2024-05-14

Completion Date

2029-05

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DRUG

INBRX-106

INBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3)

DRUG

Pembrolizumab

Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)

Locations (87)

City of Hope Medical Center

Duarte, California, United States

Los Angeles Cancer Network (LACN)

Los Angeles, California, United States

UC Davis

Sacramento, California, United States

Medical Oncology Associates of San Diego

San Diego, California, United States

Sarcoma Oncology Center

Santa Monica, California, United States

ChristianaCare Health Services

Newark, Delaware, United States

University of Florida UF Health Cancer Center

Gainesville, Florida, United States

The Oncology Institute of Hope & Innovation

Miami, Florida, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

Cleveland Clinic Florida, The Maroone Cancer Center

Weston, Florida, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University St. Louis

St Louis, Missouri, United States

Intermountain Health, St. Vincent Regional Hospital, Cancer Centers of Montana

Billings, Montana, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Oklahoma University Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

CHRISTUS Spohn Cancer Center

Corpus Christi, Texas, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Antwerp University Hospital

Edegem, Antwerp, Belgium

University Hospital Brussels

Jette, Belgium

Chu Ucl Namur Site De Sainte-Elisabeth

Namur, Belgium

Vitaz

Sint-Niklaas, Belgium

Multiprofile Hospital for Active Treatment - "Uni Hospital" Ltd, Medical Oncology Dept

Panagyurishte, Bulgaria

Complex Oncological Center Plovdiv EOOD Dept of Med Oncology and Oncological Diseases in Hematology

Plovdiv, Bulgaria

Uni Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD Clinic of Medical Oncology

Sofia, Bulgaria

Multiprofile Hospital for Active Treatment Sveta Sofia, Department of Medical Oncology

Sofia, Bulgaria

CH Annecy Genevois

Annecy, Epagny Metz Tessy, France

UNEOS-Hopital R.SCHUMAN

Metz, Moselle, France

Centre Jean Perrin

Clermont-Ferrand, France

Cenre Oscar Lambret

Lille, France

Centre Leon Berard

Lyon, France

Istituto Nazionale Tumori IRCCS - Fondazione Giovanni Pascale (National Cancer Institute)

Naples, Naples, Italy

Istituto Nazionale Tumori IRCCS - (National Cancer Institute)

Milan, Italy

European Institute of Oncology

Milan, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, Malaysia

Hospital Canselor Tuanku Muhriz (HCTM) UKM

Cheras, Kuala Lumpur, Malaysia

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Thomson Hospital Kota Damansara

Petaling Jaya, Selangor, Malaysia

Beacon Hospital

Petaling Jaya, Malaysia

Institut Kanser Negara

Putrajaya, Malaysia

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Oddział w Gliwicach

Gliwice, Poland

Przychodnia Lekarska KOMED

Konin, Poland

Provita Profamilia

Piotrkow Trybunalski, Poland

Sc Oncolab Srl

Craiova, Dolj, Romania

Sc Centrul de Oncologie Sf Nectarie Srl

Craiova, Dolj, Romania

ARENSIA Clinic Oncology Institute Bucharest

Bucharest, Romania

Arensia Exploratory Medicine S.R.L in collaboration with "Prof. Dr. Ion Chiricuta" Oncology Institute

Cluj-Napoca, Cluj, Romania

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Gachon University Gil Medical Center of Korea

Seoul, Incheon, South Korea

Keimyung University Dongsan Hospital of Korea

Daegu, South Korea

Korea Cancer Center Hospital

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Hospital Clinico Universitario de Santiago de Compostela

Santiago, A Coruña, Spain

Intituto Catalán de Oncología

Barcelona, Catalonia, Spain

IOB / Institute of Oncology, Hospital Quirónsalud Barcelona

Barcelona, Gracia, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Gregorio Marañón

Madrid, Retiro, Spain

Complexo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

MD Anderson Cancer Centre

Madrid, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Taipei Veterans General Hospital

Taipei, Beitou District / R.o.c., Taiwan

Taichung Veterans General Hospital

Taichung, China, Taiwan

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

The Royal Marsden NHS Foundation Trust, Chelsea

Chelsea, London, United Kingdom

Mount Vernon Cancer Centre

Northwood, Middlesex, United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Northern Centre for Cancer Care, Freeman Hospital

Newcastle upon Tyne, Northumbria, United Kingdom

The Royal Marsden NHS Foundation Trust, Sutton

Sutton, Surrey, United Kingdom

NHS Grampian / Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Norwich and Norfolk University Hospital

Norwich, United Kingdom