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, 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
Clinical Lead, Study Director
Inhibrx Biosciences, Inc