A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer

Last updated: March 12, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Carcinoma

Lung Cancer

Head And Neck Cancer

Treatment

Amivantamab

Carboplatin

Pembrolizumab

Clinical Study ID

NCT06385080
61186372HNC2002
61186372HNC2002
2023-508418-40-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, amivantamab in addition to paclitaxel and amivantamab in addition to pembrolizumab and carboplatin in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. The safety and preliminary efficacy of amivantamab in addition to pembrolizumab will also be determined in perioperative (before and after surgery) setting in participants with resectable locally advanced head and neck squamous cell carcinoma (HNSCC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cohorts 1 to 5: Have histologically or cytologically confirmed recurrent/metastatichead and neck squamous cell carcinoma (R/M HNSCC) that is considered incurable bylocal therapies or for Cohort 6: have histologically or cytologically confirmedlocally advanced (L/A) HNSCC that is considered curable by surgery Acceptable priorlines 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, perlocal testing); (c) Participants must provide local testing results of programmedcell death ligand 1 (PD-L1) status, if available; Cohort 4: (d) Patients must haveprimary tumor location in oropharynx. Unknown primary tumors are not included (e)Primary tumor must be HPV-positive, confirmed by positive p16 test or high-riskhuman papillomavirus (HPV) in-situ hybridization (ISH) in tissue (current orarchival) (f) Participants must provide local testing results of PD-L1 status, ifavailable; Cohort 5 (g) The eligible primary tumor locations are the oropharynx,oral cavity, hypopharynx, or larynx; (h) HPV status must be known (either positiveor negative) for patients with primary tumor location in oropharynx with p16 test orhigh-risk HPV ISH in tissue; (i) Participants must provide local testing results ofPD-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 benegative Note: All participants with an oropharyngeal tumor must have results of p16status, per local testing Participants must provide local testing results of PD-L1status (l) Participants must have Stage III or IVa disease (American Joint Committeeon Cancer Staging Manual, 8th edition). Participants must have resectable disease

  • Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according toRECIST version 1.1. Participants in Cohort 3A and Cohort 6 must have evaluabledisease (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 therapiesshould have resolved to baseline levels or to Grade 1 or less prior to the firstdose of study treatment (except for alopecia or post-radiation skin changes [anygrade], Grade less than or equal to [<=]2 peripheral neuropathy and Grade <=2hypothyroidism 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, withouthistory of red blood cell transfusion, platelet transfusion, or use of granulocytecolony-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

Exclusion Criteria:

  • Uncontrolled illness including any medical history or current (non-infectious)interstitial lung disease (ILD)/ pneumonitis/ pulmonary fibrosis, or where suspectedILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening

  • Participant with untreated brain metastases leptomeningeal disease, or spinal cordcompression not definitively treated with surgery or radiation

  • Participant with a history of clinically significant cardiovascular disease

  • Received prior chemotherapy, targeted cancer therapy, immunotherapy, or treatmentwith an investigational anticancer agent within 2 weeks or 4 half-lives, whicheveris longer, before the first administration of study treatment. The maximum requiredwashout is 28 days

  • Received radiotherapy for palliative purposes within 7 days of the firstadministration of study treatment

Study Design

Total Participants: 287
Treatment Group(s): 4
Primary Treatment: Amivantamab
Phase: 1/2
Study Start date:
April 22, 2024
Estimated Completion Date:
December 27, 2032

Connect with a study center

  • Beijing Cancer Hospital of Peking University

    Beijing, 100142
    China

    Active - Recruiting

  • Beijing Cancer Hospital of Peking University

    Beijing 1816670, 100142
    China

    Site Not Available

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

    Cheng Du Shi, 610041
    China

    Active - Recruiting

  • Linyi Cancer Hospital

    Linyi, 276002
    China

    Active - Recruiting

  • Linyi Cancer Hospital

    Linyi 1803318, 276002
    China

    Site Not Available

  • Fudan Cancer Hospital

    Shanghai, 200032
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai, 200120
    China

    Active - Recruiting

  • Fudan Cancer Hospital

    Shanghai 1796236, 200032
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai 1796236, 200120
    China

    Active - Recruiting

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

    Wuhan, 430022
    China

    Active - Recruiting

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

    Wuhan 1791247, 430022
    China

    Site Not Available

  • Institut Sainte Catherine

    Avignon, 84918
    France

    Active - Recruiting

  • Institut Sainte Catherine

    Avignon 3035681, 84918
    France

    Site Not Available

  • Institut Sainte Catherine

    Avignon Cedex 9, 84918
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille, 59000
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille 2998324, 59000
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44000
    France

    Active - Recruiting

  • CHU Nantes

    Nantes 2990969, 44000
    France

    Site Not Available

  • CHU Nantes

    Nantes Cedex 1, 44000
    France

    Site Not Available

  • Institut Curie

    PARIS Cedex 5, 75248
    France

    Site Not Available

  • Institut Curie

    Paris, 75248
    France

    Active - Recruiting

  • Institut Curie

    Paris 2988507, 75248
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif 2968705, 94805
    France

    Site Not Available

  • Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Universitaetsklinikum Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitaetsklinikum Essen

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Universitaetsklinikum Leipzig

    Leipzig, 04103
    Germany

    Completed

  • Universitaetsklinikum Leipzig

    Leipzig 2879139, 04103
    Germany

    Site Not Available

  • Klinikum der Landeshauptstadt Stuttgart

    Stuttgart, 70174
    Germany

    Active - Recruiting

  • Klinikum der Landeshauptstadt Stuttgart

    Stuttgart 2825297, 70174
    Germany

    Site Not Available

  • Aichi Cancer Center

    Nagoya, 464-8681
    Japan

    Active - Recruiting

  • Aichi Cancer Center

    Nagoya 1856057, 464-8681
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Tokyo 1850147, 160-0023
    Japan

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Pantai Hospital Kuala Lumpur

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • Pantai Hospital Kuala Lumpur

    Kuala Lumpur 1735161, 59100
    Malaysia

    Active - Recruiting

  • University Malaya Medical Centre

    Kuala Lumpur 1735161, 59100
    Malaysia

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk 3099434, 80 214
    Poland

    Site Not Available

  • Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach

    Gliwice, 44-102
    Poland

    Active - Recruiting

  • Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach

    Gliwice 3099230, 44-102
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02 781
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw 756135, 02 781
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warszawa, 02 781
    Poland

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    South Korea

    Active - Recruiting

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, 06351
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Hosp Univ Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Hosp Univ Vall D Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Inst. Cat. Doncologia-H Duran I Reynals

    Barcelona 3128760, 08908
    Spain

    Site Not Available

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Hosp. Univ. Ramon Y Cajal

    Madrid 3117735, 28034
    Spain

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua, 500
    Taiwan

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua 1993459, 500
    Taiwan

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • Chang Kung Memorial Hospital

    Kaohsiung City, 833
    Taiwan

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833
    Taiwan

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City 1673820, 833
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei 1668341, 100
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341, 112
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33382
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Taoyuan District, 33382
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan District 1667905, 33382
    Taiwan

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Addenbrooke's Hospital

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Site Not Available

  • The Royal Surrey County Hospital NHS Foundation Trust

    Guildford, GU2 7XX
    United Kingdom

    Active - Recruiting

  • The Royal Surrey County Hospital NHS Foundation Trust

    Guildford 2647793, GU2 7XX
    United Kingdom

    Site Not Available

  • Imperial College London and Imperial College Healthcare NHS Trust

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital (Sutton)

    London, SM2 5PT
    United Kingdom

    Active - Recruiting

  • University College London Hospitals

    London, W1T 7HA
    United Kingdom

    Active - Recruiting

  • Imperial College London and Imperial College Healthcare NHS Trust

    London 2643743, W12 0HS
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    London 2643743, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • University College London Hospitals

    London 2643743, W1T 7HA
    United Kingdom

    Active - Recruiting

  • The Christie Nhs Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • The Christie Nhs Foundation Trust

    Manchester 2643123, M20 4BX
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Sutton 2636503, SM2 5PT
    United Kingdom

    Site Not Available

  • University of California at San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Completed

  • University of California at San Diego Moores Cancer Center

    La Jolla 5363943, California 5332921 92093
    United States

    Site Not Available

  • University of Colorado Denver Anschultz Medical Campus

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Denver Anschultz Medical Campus

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven 4839366, Connecticut 4831725 06520
    United States

    Site Not Available

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • The University of Chicago Medical Center (UCMC)

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • University of Maryland School of Medicine

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • University of Maryland School of Medicine

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Site Not Available

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201 2013
    United States

    Active - Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201 2013
    United States

    Site Not Available

  • Washington University School Of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School Of Medicine

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School Of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Site Not Available

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • University of Utah Huntsman Cancer Institute

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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