RecruitingPhase 2Phase 3NCT06295731

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

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)

Sponsor

Inhibrx Biosciences, Inc

Enrollment

410 participants

Start Date

May 14, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — INBRX-106 plus pembrolizumab (an immunotherapy) — as a first treatment for people with advanced head and neck cancer that has spread or come back and cannot be cured with surgery or radiation. **You may be eligible if...** - You have been diagnosed with squamous cell carcinoma of the head and neck (mouth, throat, voice box, or lower throat area) that has spread or returned - Your tumor tests positive for a protein called PD-L1 at a level of 20 or higher - Your cancer has not been treated with chemotherapy or immunotherapy before (or only received it over 6 months ago as part of curative treatment) - You are able to carry out daily activities with little limitation (good performance status) - You are not pregnant or breastfeeding and are willing to use contraception **You may NOT be eligible if...** - Your cancer started in the back of the nose (nasopharynx), salivary glands, or the origin is unknown - You have active cancer that has spread to the brain or spinal fluid - You have a weakened immune system or are taking immune-suppressing medications - You have a current or past autoimmune disease requiring treatment in the last 2 years - Your disease is progressing rapidly or has a high risk of bleeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINBRX-106

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

DRUGPembrolizumab

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

Locations(88)

Gachon University Gil Medical Center of Korea

Seoul, Incheon, 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

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

Royal Adelaide Hospital

Adelaide, South Australia, Australia

City of Hope Medical Center

Duarte, California, United States

University of Florida UF Health Cancer Center

Gainesville, Florida, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Sarcoma Oncology Center

Santa Monica, California, United States

ChristianaCare Health Services

Newark, Delaware, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

Cleveland Clinic Florida, The Maroone Cancer Center

Weston, Florida, 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

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, United States

CHRISTUS Spohn Cancer Center

Corpus Christi, Texas, United States

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

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

The Oncology Institute of Hope & Innovation

Miami, Florida, United States

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

Sofia, Bulgaria

Oregon Health & Science University

Portland, Oregon, United States

Oklahoma University Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Medical Oncology Associates of San Diego

San Diego, California, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Los Angeles Cancer Network (LACN)

Los Angeles, California, United States

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

Seoul, Eunpyeong-gu, South Korea

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

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

Cluj-Napoca, Cluj, Romania

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Hospital Clinico Universitario de Santiago de Compostela

Santiago, A Coruña, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Complexo Hospitalario Universitario A Coruña

A Coruña, Spain

Intituto Catalán de Oncología

Barcelona, Catalonia, Spain

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

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

Norwich and Norfolk University Hospital

Norwich, United Kingdom

ARENSIA Clinic Oncology Institute Bucharest

Bucharest, Romania

Keimyung University Dongsan Hospital of Korea

Daegu, South Korea

Taipei Veterans General Hospital

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

Centre Leon Berard

Lyon, France

Istituto Nazionale Tumori IRCCS - (National Cancer Institute)

Milan, Italy

European Institute of Oncology

Milan, Italy

Addenbrooke's Hospital

Cambridge, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Sutter Health

Sacramento, California, United States

UC Davis

Sacramento, California, United States

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

Sofia, Bulgaria

Hospital Universitario Gregorio Marañón

Madrid, Retiro, Spain

MD Anderson Cancer Centre

Madrid, Spain

National Taiwan University Hospital

Taipei, Taiwan

IOB / Institute of Oncology, Hospital Quirónsalud Barcelona

Barcelona, Gracia, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

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NCT06295731

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