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

NCT06295731 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: INBRX106-01-201EU CT
• Study Type: interventional
• Target: 410
• Locations: 13 countries
• Sites: 87

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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Keywords

OX40 receptor agonist; PD-L1 positive; Pembrolizumab; Immunotherapy; Chemotherapy-free; HNSCC; Head and Neck Cancer; Keytruda; Oropharyngeal cancer; Hypopharyngeal cancer; Laryngeal cancer; Oral cancer; INBRX-106

Outcome Measures

Primary Outcomes (3)

• Phase 2: Objective Response Rate (ORR)

  ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on 2 consecutive occasions ≥4 weeks apart, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  up to 6 months

• Phase 3: Progression-Free Survival (PFS)

  PFS is defined as the time from randomization to first occurrence of PD, as determined by the Investigator according to RECIST v 1.1, or death from any cause (whichever occurs first).

  From randomization to first occurrence of progressive disease (PD) or death (up to 4 years)

• Phase 3: Overall Survival (OS)

  OS is the time from randomization to death due to any cause

  From randomization until death from any cause (up to 4 years)

Secondary Outcomes (10)

• Phase 3: Objective Response Rate (ORR)

  From randomization until treatment discontinuation (up to 2 years)

• Duration of Response (DOR)

  From the first occurrence of a documented objective response to PD or death (up to 4 years)

• Clinical Benefit Rate (CBR)

  From randomization until treatment discontinuation (up to 2 years)

• Phase 3: Time to Chemotherapy (TTCtx)

  From randomization until the start of chemotherapy or death (up to 4 years)

• Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference

  From randomization until treatment discontinuation (up to 2 years)

Study Arms (2)

INBRX-106 plus pembrolizumab

EXPERIMENTAL

Participants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3)

Drug: INBRX-106; Drug: Pembrolizumab

pembrolizumab monotherapy (+ placebo in phase 3 part)

ACTIVE COMPARATOR

Participants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3)

Drug: INBRX-106; Drug: Pembrolizumab

Interventions

INBRX-106 DRUG

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

Also known as: Hexavalent OX40 agonist antibody

INBRX-106 plus pembrolizumab; pembrolizumab monotherapy (+ placebo in phase 3 part)

Pembrolizumab DRUG

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

Also known as: Keytruda

INBRX-106 plus pembrolizumab; pembrolizumab monotherapy (+ placebo in phase 3 part)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inhibrx Biosciences, Inc: lead

Study Sites (87)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Los Angeles Cancer Network (LACN)

Los Angeles, California, 91204, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

Medical Oncology Associates of San Diego

San Diego, California, 92123, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

ChristianaCare Health Services

Newark, Delaware, 19713, United States

Location

University of Florida UF Health Cancer Center

Gainesville, Florida, 32608, United States

Location

The Oncology Institute of Hope & Innovation

Miami, Florida, 33169, United States

Location

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

Location

Cleveland Clinic Florida, The Maroone Cancer Center

Weston, Florida, 33331, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Washington University St. Louis

St Louis, Missouri, 63110, United States

Location

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

Billings, Montana, 59102, United States

Location

Oncology Hematology West, PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, 87505, United States

Location

UNC Lineberger Comprehensive Cancer Center

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

Location

Oklahoma University Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

CHRISTUS Spohn Cancer Center

Corpus Christi, Texas, 78404, United States

Location

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

University Hospital Brussels

Jette, 1090, Belgium

Location

Chu Ucl Namur Site De Sainte-Elisabeth

Namur, 5000, Belgium

Location

Vitaz

Sint-Niklaas, 9100, Belgium

Location

Multiprofile Hospital for Active Treatment - "Uni Hospital" Ltd, Medical Oncology Dept

Panagyurishte, 4500, Bulgaria

Location

Complex Oncological Center Plovdiv EOOD Dept of Med Oncology and Oncological Diseases in Hematology

Plovdiv, 4004, Bulgaria

Location

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

Sofia, 1527, Bulgaria

Location

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

Sofia, 1618, Bulgaria

Location

CH Annecy Genevois

Annecy, Epagny Metz Tessy, 74370, France

Location

UNEOS-Hopital R.SCHUMAN

Metz, Moselle, 57000, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Cenre Oscar Lambret

Lille, 59000, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

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

Naples, Naples, 80131, Italy

Location

Istituto Nazionale Tumori IRCCS - (National Cancer Institute)

Milan, 20133, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Hospital Canselor Tuanku Muhriz (HCTM) UKM

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

Location

Thomson Hospital Kota Damansara

Petaling Jaya, Selangor, 47810, Malaysia

Location

Beacon Hospital

Petaling Jaya, 46050, Malaysia

Location

Institut Kanser Negara

Putrajaya, 62250, Malaysia

Location

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Oddział w Gliwicach

Gliwice, 44-102, Poland

Location

Przychodnia Lekarska KOMED

Konin, 62-500, Poland

Location

Provita Profamilia

Piotrkow Trybunalski, 97-300, Poland

Location

Sc Oncolab Srl

Craiova, Dolj, 200385, Romania

Location

Sc Centrul de Oncologie Sf Nectarie Srl

Craiova, Dolj, 200745, Romania

Location

ARENSIA Clinic Oncology Institute Bucharest

Bucharest, 022328, Romania

Location

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

Cluj-Napoca, Cluj, 400015, Romania

Location

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

Seoul, Eunpyeong-gu, 03312, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Gachon University Gil Medical Center of Korea

Seoul, Incheon, 21565, South Korea

Location

Keimyung University Dongsan Hospital of Korea

Daegu, 42601, South Korea

Location

Korea Cancer Center Hospital

Seoul, 01812, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital Clinico Universitario de Santiago de Compostela

Santiago, A Coruña, 15706, Spain

Location

Intituto Catalán de Oncología

Barcelona, Catalonia, 08908, Spain

Location

IOB / Institute of Oncology, Hospital Quirónsalud Barcelona

Barcelona, Gracia, 08023, Spain

Location

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, Retiro, 28007, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

MD Anderson Cancer Centre

Madrid, 28033, Spain

Location

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

Taipei Veterans General Hospital

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

Location

Taichung Veterans General Hospital

Taichung, China, 407219, Taiwan

Location

Changhua Christian Medical Foundation Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100226, Taiwan

Location

The Royal Marsden NHS Foundation Trust, Chelsea

Chelsea, London, SW36JJ, United Kingdom

Location

Mount Vernon Cancer Centre

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Northern Centre for Cancer Care, Freeman Hospital

Newcastle upon Tyne, Northumbria, NE7 7DN, United Kingdom

Location

The Royal Marsden NHS Foundation Trust, Sutton

Sutton, Surrey, SM25PT, United Kingdom

Location

NHS Grampian / Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M204BX, United Kingdom

Location

Norwich and Norfolk University Hospital

Norwich, NR47UY, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Mouth Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Mouth Diseases

Study Officials

• Clinical Lead

  Inhibrx Biosciences, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Phase 2: open label; Phase 3: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 6, 2024
• Study Start: May 14, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4); FR (5); PL (3); KR (8); ES (9); RO (4); TW (6); US (25); BU (4); GB (8); MY (6); AU (1); BE (4)