This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safetyof the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibodypembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment forpatients with locally advanced recurrent or metastatic head and neck squamous cellcarcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combinedproportion score (CPS) ≥20.
Not Provided
Drug: INBRX-106
INBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3)
Other Name: Hexavalent OX40 agonist antibody
Drug: Pembrolizumab
Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)
Other Name: Keytruda
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Has primary tumor site (any histology) of nasopharynx or salivary glands or occult
primary site.
- Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy)
for locally advanced unresectable or metastatic HNSCC.
- Prior systemic therapy completed >6 months prior to signing informed consent is
allowed if given as part of multimodal treatment for locoregionally advanced
disease with curative intent, and no PD/recurrence occurred within 6 months of
its completion. Prior systemic immunotherapy in the locoregionally advanced
disease with curative intent, including but not limited to anti-PD-(L)1 agents,
is allowed if PD/recurrence occurred ≥12 months after its completion.
- Has clinically active central nervous system metastases and/or carcinomatous
meningitis.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of
study treatment.
- Rapidly progressing disease or with features that may confer a high risk of
tumor-associated hemorrhage or uncontrolled tumor pain.
- Current or history of immune-related disease that required systemic treatment in
past 2 years, except for replacement therapy.
City of Hope Medical Center
Duarte 5344147, California 5332921, United States
Los Angeles Cancer Network (LACN)
Los Angeles 5368361, California 5332921, United States
Sutter Health
Sacramento 5389489, California 5332921, United States
UC Davis
Sacramento 5389489, California 5332921, United States
Medical Oncology Associates of San Diego
San Diego 5391811, California 5332921, United States
Sarcoma Oncology Center
Santa Monica 5393212, California 5332921, United States
ChristianaCare Health Services
Newark 4143861, Delaware 4142224, United States
The Oncology Institute of Hope & Innovation
Miami 4164138, Florida 4155751, United States
Mid Florida Hematology and Oncology Center
Orange City 4167055, Florida 4155751, United States
Cleveland Clinic Florida, The Maroone Cancer Center
Weston 4178003, Florida 4155751, United States
University of Illinois Cancer Center
Chicago 4887398, Illinois 4896861, United States
Norton Cancer Institute
Louisville 4299276, Kentucky 6254925, United States
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926, United States
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836, United States
Washington University St. Louis
St Louis 4407066, Missouri 4398678, United States
Intermountain Health, St. Vincent Regional Hospital, Cancer Centers of Montana
Billings 5640350, Montana 5667009, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha 5074472, Nebraska 5073708, United States
Comprehensive Cancer Centers of Nevada
Las Vegas 5506956, Nevada 5509151, United States
Christus St. Vincent Regional Cancer Center
Santa Fe 5490263, New Mexico 5481136, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348, United States
Oklahoma University Stephenson Cancer Center
Oklahoma City 4544349, Oklahoma 4544379, United States
Oregon Health & Science University
Portland 5746545, Oregon 5744337, United States
UPMC Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927, United States
CHRISTUS Spohn Cancer Center
Corpus Christi 4683416, Texas 4736286, United States
VCU Massey Comprehensive Cancer Center
Richmond 4781708, Virginia 6254928, United States
Royal Adelaide Hospital
Adelaide 2078025, South Australia 2061327, Australia
University Hospital Brussels
Jette 2794914, Belgium
Chu Ucl Namur Site De Sainte-Elisabeth
Namur 2790471, Belgium
Vitaz
Sint-Niklaas 2786578, Belgium
UNEOS-Hopital R.SCHUMAN
Metz 2994160, Moselle, France
Centre Leon Berard
Lyon 2996944, France
European Institute of Oncology
Milan 3173435, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia 3171366, Italy
Hospital Universiti Sains Malaysia
Kubang Kerian 1759391, Kelantan 1733044, Malaysia
Hospital Canselor Tuanku Muhriz (HCTM) UKM
Cheras, Kuala Lumpur 1733046, Malaysia
Sarawak General Hospital
Kuching 1735634, Sarawak 1733038, Malaysia
Institut Kanser Negara
Putrajaya 6697380, Malaysia
Przychodnia Lekarska KOMED
Konin 3095321, Poland
Provita Profamilia
Piotrkow Trybunalski 3088972, Poland
Sc Oncolab Srl
Craiova 680332, Dolj 679134, Romania
Sc Centrul de Oncologie Sf Nectarie Srl
Craiova 680332, Dolj 679134, Romania
ARENSIA Clinic Oncology Institute Bucharest
Bucharest 683506, 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 1832828, Gyeongsangnam-do 1902028, South Korea
Gachon University Gil Medical Center of Korea
Seoul, Incheon 1843561, South Korea
Keimyung University Dongsan Hospital of Korea
Daegu 1835329, South Korea
Korea Cancer Center Hospital
Seoul 1835848, South Korea
Korea University Anam Hospital
Seoul 1835848, South Korea
Severance Hospital, Yonsei University Health System
Seoul 1835848, South Korea
Korea University Guro Hospital
Seoul 1835848, South Korea
Intituto Catalán de Oncología
Barcelona 3128760, Catalonia 3336901, Spain
IOB / Institute of Oncology, Hospital Quirónsalud Barcelona
Barcelona 3128760, Gracia, Spain
Hospital Universitario de Navarra
Pamplona 3114472, Navarre 3115609, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña 3119841, Spain
Hospital Clinic de Barcelona
Barcelona 3128760, Spain
MD Anderson Cancer Centre
Madrid 3117735, Spain
Hospital Universitario y Politécnico La Fe
Valencia 2509954, Spain
Taipei Veterans General Hospital
Taipei 1668341, Beitou District / R.o.c., Taiwan
Taichung Veterans General Hospital
Taichung 1668399, China, Taiwan
National Taiwan University Hospital
Taipei 1668341, Taiwan
The Royal Marsden NHS Foundation Trust, Chelsea
Chelsea 2653265, London, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton
Sutton 2636503, Surrey, United Kingdom
NHS Grampian / Aberdeen Royal Infirmary
Aberdeen 2657832, United Kingdom
Addenbrooke's Hospital
Cambridge 2653941, United Kingdom
Study Director - Inhibrx
858-500-7833
clinicaltrials@inhibrx.com
Clinical Lead, Study Director
Inhibrx Biosciences, Inc