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)
Status: Recruiting
Location: See all (88) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies.
• Has tumor PD-L1 expression of CPS ≥20. Tumor tissue must be provided for PD-L1 biomarker analysis.
• Has human papilloma virus (HPV) testing results for oropharyngeal cancer by p16 immunohistochemistry (IHC) testing.
• Has measurable disease per RECIST 1.1 guidelines.
• Has the primary tumor location of the oral cavity, oropharynx, hypopharynx, or larynx.
• Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Female patients of childbearing potential must have a negative highly sensitive pregnancy test within 72 hours prior to randomization and must not be breastfeeding.
• Male and female patients of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use a highly effective method of contraception.
Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Los Angeles Cancer Network (LACN)
RECRUITING
Los Angeles
Sutter Health
RECRUITING
Sacramento
UC Davis
RECRUITING
Sacramento
Medical Oncology Associates of San Diego
RECRUITING
San Diego
Sarcoma Oncology Center
RECRUITING
Santa Monica
Delaware
ChristianaCare Health Services
RECRUITING
Newark
Florida
University of Florida UF Health Cancer Center
RECRUITING
Gainesville
The Oncology Institute of Hope & Innovation
RECRUITING
Miami
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
Cleveland Clinic Florida, The Maroone Cancer Center
RECRUITING
Weston
Illinois
University of Illinois Cancer Center
RECRUITING
Chicago
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Missouri
Washington University St. Louis
RECRUITING
St Louis
Montana
Intermountain Health, St. Vincent Regional Hospital, Cancer Centers of Montana
RECRUITING
Billings
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Nebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists
RECRUITING
Omaha
New Mexico
Christus St. Vincent Regional Cancer Center
RECRUITING
Santa Fe
Nevada
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
Oklahoma
Oklahoma University Stephenson Cancer Center
RECRUITING
Oklahoma City
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Texas
CHRISTUS Spohn Cancer Center
RECRUITING
Corpus Christi
Virginia
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Belgium
Antwerp University Hospital
RECRUITING
Edegem
University Hospital Brussels
RECRUITING
Jette
Chu Ucl Namur Site De Sainte-Elisabeth
RECRUITING
Namur
Vitaz
RECRUITING
Sint-niklaas
Bulgaria
Multiprofile Hospital for Active Treatment - Uni Hospital Ltd, Medical Oncology Dept
RECRUITING
Panagyurishte
Complex Oncological Center Plovdiv EOOD Dept of Med Oncology and Oncological Diseases in Hematology
RECRUITING
Plovdiv
Multiprofile Hospital for Active Treatment Sveta Sofia, Department of Medical Oncology
RECRUITING
Sofia
Uni Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD Clinic of Medical Oncology
RECRUITING
Sofia
France
CH Annecy Genevois
RECRUITING
Annecy
Centre Jean Perrin
RECRUITING
Clermont-ferrand
Cenre Oscar Lambret
RECRUITING
Lille
Centre Leon Berard
RECRUITING
Lyon
UNEOS-Hopital R.SCHUMAN
RECRUITING
Metz
Italy
European Institute of Oncology
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS - (National Cancer Institute)
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS - Fondazione Giovanni Pascale (National Cancer Institute)
RECRUITING
Napoli
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Malaysia
Hospital Canselor Tuanku Muhriz (HCTM) UKM
RECRUITING
Cheras
Hospital Universiti Sains Malaysia
RECRUITING
Kubang Kerian
Sarawak General Hospital
RECRUITING
Kuching
Beacon Hospital
RECRUITING
Petaling Jaya
Thomson Hospital Kota Damansara
RECRUITING
Petaling Jaya
Institut Kanser Negara
RECRUITING
Putrajaya
Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Oddział w Gliwicach
RECRUITING
Gliwice
Przychodnia Lekarska KOMED
RECRUITING
Konin
Provita Profamilia
RECRUITING
Piotrkow Trybunalski
Republic of Korea
Keimyung University Dongsan Hospital of Korea
RECRUITING
Daegu
Gachon University Gil Medical Center of Korea
RECRUITING
Seoul
Korea Cancer Center Hospital
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Pusan National University Yangsan Hospital
RECRUITING
Yangsan
Romania
ARENSIA Clinic Oncology Institute Bucharest
RECRUITING
Bucharest
Arensia Exploratory Medicine S.R.L in collaboration with Prof. Dr. Ion Chiricuta Oncology Institute
RECRUITING
Cluj-napoca, Cluj
Sc Centrul de Oncologie Sf Nectarie Srl
RECRUITING
Craiova
Sc Oncolab Srl
RECRUITING
Craiova
Spain
Complexo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Intituto Catalán de Oncología
RECRUITING
Barcelona
IOB / Institute of Oncology, Hospital Quirónsalud Barcelona
RECRUITING
Barcelona
Hospital Universitario Gregorio Marañón
RECRUITING
Madrid
MD Anderson Cancer Centre
RECRUITING
Madrid
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Clinico Universitario de Santiago de Compostela
RECRUITING
Santiago
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Taiwan
Changhua Christian Medical Foundation Changhua Christian Hospital
RECRUITING
Changhua
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
United Kingdom
NHS Grampian / Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Addenbrooke's Hospital
RECRUITING
Cambridge
The Royal Marsden NHS Foundation Trust, Chelsea
RECRUITING
Chelsea
The Christie NHS Foundation Trust
RECRUITING
Manchester
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Northern Centre for Cancer Care, Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Mount Vernon Cancer Centre
RECRUITING
Northwood
Norwich and Norfolk University Hospital
RECRUITING
Norwich
The Royal Marsden NHS Foundation Trust, Sutton
RECRUITING
Sutton
Contact Information
Primary
Study Director - Inhibrx
clinicaltrials@inhibrx.com
858-500-7833
Time Frame
Start Date: 2024-05-14
Estimated Completion Date: 2029-05
Participants
Target number of participants: 410
Treatments
Experimental: INBRX-106 plus pembrolizumab
Participants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3)
Active_comparator: pembrolizumab monotherapy (+ placebo in phase 3 part)
Participants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3)
Related Therapeutic Areas
Sponsors
Leads: Inhibrx Biosciences, Inc