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New drug cocktail aims to fight head and neck cancer

NCT ID NCT06385080

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study tests a drug called amivantamab, either alone or combined with other cancer drugs (pembrolizumab, paclitaxel, carboplatin), in people with head and neck cancer that has spread or come back. The goal is to see if these treatments are safe and can shrink tumors. About 287 participants will take part, and the study also looks at using amivantamab with pembrolizumab before and after surgery for certain patients.

What this could mean

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

Active substance
Amivantamab (a biologic drug) given alone or with pembrolizumab, paclitaxel, or carboplatin
What this could lead to
If successful, this could point toward new treatment options for people with head and neck cancer that has spread or come back.
What could go wrong
This is an early-phase trial (phase 1b/2) with a small number of participants, so results may not apply to everyone. Side effects from the drug combinations could be serious.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 287 people

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

Started

Apr 2024

Expected to finish

Jul 2033

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: * Cohorts 1 to 5: Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies or for Cohort 6: have histologically or cytologically confirmed locally advanced (L/A) HNSCC that is considered curable by surgery Acceptable prior lines of therapy will be determined according to specific cohort 1, 2, 3A and 3B: (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) Any known p16 status of tumor must be negative (Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing); (c) Participants must provide local testing results of programmed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (d) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (e) Primary tumor must be HPV-positive, confirmed by positive p16 test or high-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current or archival) (f) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (g) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (h) HPV status must be known (either positive or negative) for patients with primary tumor location in oropharynx with p16 test or high-risk HPV ISH in tissue; (i) Participants must provide local testing results of PD-L1 status; Cohort 6: (j) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (k) Any known p16 status of tumor must be negative Note: All participants with an oropharyngeal tumor must have results of p16 status, per local testing Participants must provide local testing results of PD-L1 status (l) Participants must have Stage III or IVa disease (American Joint Committee on Cancer Staging Manual, 8th edition). Participants must have resectable disease * Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A and Cohort 6 must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1. * Cohorts 1, 2, 3A, 3B, 4, and 5 only: Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less prior to the first dose of study treatment (except for alopecia or post-radiation skin changes \[any grade\], Grade less than or equal to \[\<=\]2 peripheral neuropathy and Grade \<=2 hypothyroidism stable on hormone replacement) * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or use of granulocyte colony-stimulating factor within 7 days prior to the date of the laboratory test. Participants should have: a) Hemoglobin \>=9 grams per deciliter (g/dL); b) Neutrophils \>=1.5 x 10\^3/mcg; c) Platelets \>=100 x 10\^3/mcg Exclusion Criteria: * Uncontrolled illness including any medical history or current (non-infectious) interstitial lung disease (ILD)/ pneumonitis/ pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening * Participant with untreated brain metastases leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation * Participant with a history of clinically significant cardiovascular disease * Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives, whichever is longer, before the first administration of study treatment. The maximum required washout is 28 days * Received radiotherapy for palliative purposes within 7 days of the first administration of study treatment

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Squamous cell carcinoma of head and neck

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    51 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Aichi Cancer Center

    RECRUITING

    Nagoya, 464-8681, Japan

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Beijing Cancer Hospital of Peking University

    COMPLETED

    Beijing, 100142, China

  • CHU Nantes

    RECRUITING

    Nantes, 44000, France

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59000, France

  • Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach

    RECRUITING

    Gliwice, 44-102, Poland

  • Changhua Christian Hospital

    RECRUITING

    Changhua, 500, Taiwan

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Fudan Cancer Hospital

    RECRUITING

    Shanghai, 200032, China

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Hosp Univ Vall D Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hosp. Univ. 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hosp. Univ. Ramon Y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Imperial College London and Imperial College Healthcare NHS Trust

    COMPLETED

    London, W12 0HS, United Kingdom

  • Inst. Cat. Doncologia-H Duran I Reynals

    RECRUITING

    Barcelona, 08908, Spain

  • Institut Curie

    RECRUITING

    Paris, 75248, France

  • Institut Sainte Catherine

    RECRUITING

    Avignon, 84918, France

  • Kaohsiung Chang Gung Memorial Hospital

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201 2013, United States

  • Klinikum der Landeshauptstadt Stuttgart

    RECRUITING

    Stuttgart, 70174, Germany

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, 33382, Taiwan

  • Linyi Cancer Hospital

    COMPLETED

    Linyi, 276002, China

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    RECRUITING

    Warsaw, 02 781, Poland

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Pantai Hospital Kuala Lumpur

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Royal Marsden Hospital

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • Royal Marsden Hospital (Sutton)

    RECRUITING

    London, SM2 5PT, United Kingdom

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Shanghai East Hospital

    RECRUITING

    Shanghai, 200120, China

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112, Taiwan

  • The Christie Nhs Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Royal Surrey County Hospital NHS Foundation Trust

    RECRUITING

    Guildford, GU2 7XX, United Kingdom

  • The University of Chicago Medical Center (UCMC)

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Tokyo Medical University Hospital

    RECRUITING

    Tokyo, 160-0023, Japan

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    RECRUITING

    Wuhan, 430022, China

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitaetsklinikum Leipzig

    COMPLETED

    Leipzig, 04103, Germany

  • University College London Hospitals

    RECRUITING

    London, W1T 7HA, United Kingdom

  • University Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • University of California at San Diego Moores Cancer Center

    COMPLETED

    La Jolla, California, 92093, United States

  • University of Colorado Denver Anschultz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Maryland School of Medicine

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Utah Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80 214, Poland

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Washington University School Of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • West China School of Medicine/West China Hospital, Sichuan University

    RECRUITING

    Cheng Du Shi, 610041, China

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

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Other studies related to the condition(s) this trial covers.