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NCT06295731 | RECRUITING | Head and Neck Squamous Cell Carcinoma (HNSCC)


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

Inhibrx Biosciences, Inc

Brief 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.

Condition or disease

Head and Neck Squamous Cell Carcinoma (HNSCC)

Intervention/treatment

INBRX-106

Pembrolizumab

Phase

PHASE2

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 410 participants
Masking : DOUBLE
Masking Description : Phase 2: open label; Phase 3: double-blind
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2024-05-14
Estimated Primary Completion Date : 2029-05
Estimated Study Completion Date : 2029-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

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

Location Details

NCT06295731


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, California

City of Hope Medical Center

Duarte, California, United States, 91010

RECRUITING

United States, California

Los Angeles Cancer Network (LACN)

Los Angeles, California, United States, 91204

RECRUITING

United States, California

Sutter Health

Sacramento, California, United States, 95816

RECRUITING

United States, California

UC Davis

Sacramento, California, United States, 95817

RECRUITING

United States, California

Medical Oncology Associates of San Diego

San Diego, California, United States, 92123

RECRUITING

United States, California

Sarcoma Oncology Center

Santa Monica, California, United States, 90403

RECRUITING

United States, Delaware

ChristianaCare Health Services

Newark, Delaware, United States, 19713

RECRUITING

United States, Florida

The Oncology Institute of Hope & Innovation

Miami, Florida, United States, 33169

RECRUITING

United States, Florida

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States, 32763

RECRUITING

United States, Florida

Cleveland Clinic Florida, The Maroone Cancer Center

Weston, Florida, United States, 33331

RECRUITING

United States, Illinois

University of Illinois Cancer Center

Chicago, Illinois, United States, 60612

RECRUITING

United States, Kentucky

Norton Cancer Institute

Louisville, Kentucky, United States, 40202

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Road cancer

Karmanos Cancer Institute

Detroit, Road cancer, United States, 48201

RECRUITING

United States, Missouri

Washington University St. Louis

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, Montana

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

Billings, Montana, United States, 59102

RECRUITING

United States, Nebraska

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130

RECRUITING

United States, Nevada

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

RECRUITING

United States, New Mexico

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, United States, 87505

RECRUITING

United States, North Carolina

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599-7305

RECRUITING

United States, Oklahola

Oklahoma University Stephenson Cancer Center

Ololama City, Okholohan, United States, 73104

RECRUITING

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Pennsylvania

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

United States, Texas

CHRISTUS Spohn Cancer Center

Corpus Christi, Texas, United States, 78404

RECRUITING

United States, Virginia

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States, 23298

RECRUITING

Australia, South Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

RECRUITING

Belgium,

University Hospital Brussels

Throw, Belgium, 1090

RECRUITING

Belgium,

CHU UCL Namur Sainte-Elisabeth Site

Namur, Belgium, 5000

RECRUITING

Belgium,

Vitaz

Sint-Niklaas, Belgium, 9100

RECRUITING

France, Moselle

Uneos-Hopital R.Schuman

Metz, Moselle, France, 57000

RECRUITING

France,

Center Leon Berard

Lyon, France, 69008

RECRUITING

Italy,

European Institute of Oncology

Milan, Italy, 20141

RECRUITING

Italy,

IRCCS Policlinico San Matteo Foundation

Pavia, Italy, 27100

RECRUITING

Korea, Republic of, Gyeongsangnam-do

Pusan National University Yang Hospital

The, Gyeongsangnam-do, Korea, Republic of, 50612

RECRUITING

Korea, Republic of, Incheon

Gachon University Gil Medical Center of Korea

Seoul, Incheon, Korea, Republic of, 21565

RECRUITING

Korea, Republic of,

Keimyung University Dongsan Hospital of Korea

Daegu, Korea, Republic of, 42601

RECRUITING

Korea, Republic of,

Korea Cancer Center Hospital

Seoul, Korea, Republic of, 01812

RECRUITING

Korea, Republic of,

Korea University Anam Hospital

Seoul, Korea, Republic of, 02841

RECRUITING

Korea, Republic of,

Severance Hospital, Yonsei University Health System

Seoul, Korea, Republic of, 03722

RECRUITING

Korea, Republic of,

Korea University Teacher Hospital

Seoul, Korea, Republic of, 08308

RECRUITING

Malaysia, Kelantan

University of Science Malaysia Hospital

Kubang kerian, Kelantan, Malaysia, 16150

RECRUITING

Malaysia, Sarawak

Sarawak General Hospital

Kuching, Sarawak, Malaysia, 93586

RECRUITING

Malaysia, Federal Territory of Kuala Lumpur

Hospital Chancellor Tuanku Muhriz (HCTM) UKM

Cheras, Federal Territory of Kuala Lumpur, Malaysia, 56000

RECRUITING

Malaysia,

National Cancer Institute

Putrajaya, Malaysia, 62250

RECRUITING

Poland,

Comedy medical clinic

Konin, Poland, 62-500

RECRUITING

Poland,

Proven Profamilia

Piotrków Trybunalski, Poland, 97-300

RECRUITING

Romania, Dolj

SC oncolab etc.

Craiova, Dolj, Romania, 200385

RECRUITING

Romania, Dolj

SC SF NECTARIE SRL oncology Center

Craiova, Dolj, Romania, 200745

RECRUITING

Romania,

ARENSIA Clinic Oncology Institute Bucharest

Bucharest, Romania, 022328

RECRUITING

Romania,

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

Cluj-Napoca, Cluj, Romania, 400015

RECRUITING

Spain, Catalonia

Catalan Institute of Oncology

Barcelona, Catalonia, Spain, 08908

RECRUITING

Spain, Gracia

IOB / Institute of Oncology, Quirónsalud Barcelona Hospital

Barcelona, Gracia, Spain, 08023

RECRUITING

Spain, Navarra

Navarra University Hospital

Pamplona, Navarra, Spain, 31008

RECRUITING

Spain,

Clinic Hospital in Barcelona

Barcelona, Spain, 08036

RECRUITING

Spain,

UNIVERSITY HOSPITAL COMPLEX A CORUÑA

Coruña, Spain, 15006

RECRUITING

Spain,

MD Anderson Cancer Centre

Madrid, Spain, 28033

RECRUITING

Spain,

La Fe University and Polytechnic Hospital

Valencia, Spain,

RECRUITING

Taiwan, Beitou District / R.o.c.

Taipei Veterans General Hospital

Taipei City, Beitou District / R.o.c., Taiwan, 11217

RECRUITING

Taiwan, China

Taichung Veterans General Hospital

Taichung, China, Taiwan, 407219

RECRUITING

Taiwan,

National Taiwan University Hospital

Taipei City, Taiwan, 100226

RECRUITING

United Kingdom, London

The Royal Marsden NHS Foundation Trust, Chelsea

Chelsea, London, United Kingdom, Juice

RECRUITING

United Kingdom, Surrey

The Royal Marsden NHS Foundation Trust, Sutton

Suton, Surrey, United Kingdom, Cm25pT

RECRUITING

United Kingdom,

NHS Grampian / Aberdeen Royal Infirmary

Aberdeen, United Kingdom, I am a brother

RECRUITING

United Kingdom,

Addenbrooke's Hospital

Cambridge, United Kingdom, CB2 0QQ

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