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New drug duo aims to supercharge immunotherapy against head and neck cancer

NCT ID NCT06295731

Disease control Sponsor: Inhibrx Biosciences, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding an experimental drug called INBRX-106 to the standard immunotherapy pembrolizumab (Keytruda) works better than pembrolizumab alone for people with advanced head and neck cancer that has spread or come back. About 410 participants whose tumors have a specific marker (PD-L1 CPS ≥20) will be randomly assigned to receive either the combination or pembrolizumab alone. The goal is to see if the combo shrinks tumors more effectively and helps people live longer without their cancer getting worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INBRX-106 (an experimental immune-boosting antibody) combined with pembrolizumab (Keytruda)
What this could lead to
If successful, this combination could improve tumor shrinkage and delay cancer progression or death compared to standard immunotherapy alone for certain head and neck cancers.
What could go wrong
This is an early-to-mid-stage trial (phase 2/3) with 410 participants, so results may not confirm benefit. Adding INBRX-106 could also increase immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 410 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms head and neck squamous cell carcinoma hypopharynx cancer laryngeal neoplasm Mouth Neoplasms oropharynx cancer Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma HNSCC

Contacts and locations

Locations

  • ARENSIA Clinic Oncology Institute Bucharest

    Bucharest, 022328, Romania

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Antwerp University Hospital

    Edegem, Antwerp, 2650, Belgium

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

    Cluj-Napoca, Cluj, 400015, Romania

  • Beacon Hospital

    Petaling Jaya, 46050, Malaysia

  • CH Annecy Genevois

    Annecy, Epagny Metz Tessy, 74370, France

  • CHRISTUS Spohn Cancer Center

    Corpus Christi, Texas, 78404, United States

  • Cenre Oscar Lambret

    Lille, 59000, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Changhua, 500, Taiwan

  • ChristianaCare Health Services

    Newark, Delaware, 19713, United States

  • Christus St. Vincent Regional Cancer Center

    Santa Fe, New Mexico, 87505, United States

  • Chu Ucl Namur Site De Sainte-Elisabeth

    Namur, 5000, Belgium

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • Cleveland Clinic Florida, The Maroone Cancer Center

    Weston, Florida, 33331, United States

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

    Plovdiv, 4004, Bulgaria

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, 15006, Spain

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • European Institute of Oncology

    Milan, 20141, Italy

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Gachon University Gil Medical Center of Korea

    Seoul, Incheon, 21565, South Korea

  • Hospital Canselor Tuanku Muhriz (HCTM) UKM

    Cheras, Kuala Lumpur, 56000, Malaysia

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago, A Coruña, 15706, Spain

  • Hospital Universitario Gregorio Marañón

    Madrid, Retiro, 28007, Spain

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Hospital Universitario y Politécnico La Fe

    Valencia, Spain

  • Hospital Universiti Sains Malaysia

    Kubang Kerian, Kelantan, 16150, Malaysia

  • IOB / Institute of Oncology, Hospital Quirónsalud Barcelona

    Barcelona, Gracia, 08023, Spain

  • Institut Kanser Negara

    Putrajaya, 62250, Malaysia

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

    Billings, Montana, 59102, United States

  • Intituto Catalán de Oncología

    Barcelona, Catalonia, 08908, Spain

  • Istituto Nazionale Tumori IRCCS - (National Cancer Institute)

    Milan, 20133, Italy

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

    Naples, Naples, 80131, Italy

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Keimyung University Dongsan Hospital of Korea

    Daegu, 42601, South Korea

  • Korea Cancer Center Hospital

    Seoul, 01812, South Korea

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Los Angeles Cancer Network (LACN)

    Los Angeles, California, 91204, United States

  • MD Anderson Cancer Centre

    Madrid, 28033, Spain

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Oncology Associates of San Diego

    San Diego, California, 92123, United States

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763, United States

  • Mount Vernon Cancer Centre

    Northwood, Middlesex, HA6 2RN, United Kingdom

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

    Panagyurishte, 4500, Bulgaria

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

    Sofia, 1618, Bulgaria

  • NHS Grampian / Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN, United Kingdom

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

    Gliwice, 44-102, Poland

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 100226, Taiwan

  • Norton Cancer Institute

    Louisville, Kentucky, 40202, United States

  • Norwich and Norfolk University Hospital

    Norwich, NR47UY, United Kingdom

  • Oklahoma University Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Provita Profamilia

    Piotrkow Trybunalski, 97-300, Poland

  • Przychodnia Lekarska KOMED

    Konin, 62-500, Poland

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Sarawak General Hospital

    Kuching, Sarawak, 93586, Malaysia

  • Sarcoma Oncology Center

    Santa Monica, California, 90403, United States

  • Sc Centrul de Oncologie Sf Nectarie Srl

    Craiova, Dolj, 200745, Romania

  • Sc Oncolab Srl

    Craiova, Dolj, 200385, Romania

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Taichung Veterans General Hospital

    Taichung, China, 407219, Taiwan

  • Taipei Veterans General Hospital

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

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

    Seoul, Eunpyeong-gu, 03312, South Korea

  • The Christie NHS Foundation Trust

    Manchester, M204BX, United Kingdom

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

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

  • The Oncology Institute of Hope & Innovation

    Miami, Florida, 33169, United States

  • The Royal Marsden NHS Foundation Trust, Chelsea

    Chelsea, London, SW36JJ, United Kingdom

  • The Royal Marsden NHS Foundation Trust, Sutton

    Sutton, Surrey, SM25PT, United Kingdom

  • Thomson Hospital Kota Damansara

    Petaling Jaya, Selangor, 47810, Malaysia

  • UC Davis

    Sacramento, California, 95817, United States

  • UNC Lineberger Comprehensive Cancer Center

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

  • UNEOS-Hopital R.SCHUMAN

    Metz, Moselle, 57000, France

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

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

    Sofia, 1527, Bulgaria

  • University Hospital Brussels

    Jette, 1090, Belgium

  • University of Florida UF Health Cancer Center

    Gainesville, Florida, 32608, United States

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612, United States

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298, United States

  • Vitaz

    Sint-Niklaas, 9100, Belgium

  • Washington University St. Louis

    St Louis, Missouri, 63110, United States

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