Back to Trials
NCT06385080PHASE1, PHASE2Recruiting

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

Janssen Research & Development, LLC

Start Date

4/22/2024

Completion Date

12/27/2032

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

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

Amivantamab

BIOLOGICAL

Pembrolizumab

DRUG

Paclitaxel

DRUG

Carboplatin

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Squamous Cell Carcinoma of Head and Neck

Locations

University of California at San Diego Moores Cancer Center

La Jolla, California 92093

United States

University of Colorado Denver Anschultz Medical Campus

Aurora, Colorado 80045

United States

Yale Cancer Center

New Haven, Connecticut 06520

United States

The University of Chicago Medical Center (UCMC)

Chicago, Illinois 60637

United States

University of Maryland School of Medicine

Baltimore, Maryland 21201

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02115

United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan 48109

United States

Karmanos Cancer Institute

Detroit, Michigan 48201 2013

United States

Washington University School Of Medicine

St Louis, Missouri 63110

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

University of Virginia

Charlottesville, Virginia 22903

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Beijing Cancer Hospital of Peking University

Beijing, 100142

China

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

Cheng Du Shi, 610041

China

Linyi Cancer Hospital

Linyi, 276002

China

Fudan Cancer Hospital

Shanghai, 200032

China

Shanghai East Hospital

Shanghai, 200120

China

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

Wuhan, 430022

China

Institut Sainte Catherine

Avignon, 84918

France

Centre Oscar Lambret

Lille, 59000

France

CHU Nantes

Nantes, 44000

France

Institut Curie

Paris, 75248

France

Gustave Roussy

Villejuif, 94805

France

Universitaetsklinikum Essen

Essen, 45147

Germany

Universitaetsklinikum Leipzig

Leipzig, 04103

Germany

Klinikum der Landeshauptstadt Stuttgart

Stuttgart, 70174

Germany

Aichi Cancer Center

Nagoya, 464-8681

Japan

Tokyo Medical University Hospital

Tokyo, 160-0023

Japan

Pantai Hospital Kuala Lumpur

Kuala Lumpur, 59100

Malaysia

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214

Poland

Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach

Gliwice, 44-102

Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, 02 781

Poland

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, 08908

Spain

Hosp. Univ. Ramon Y Cajal

Madrid, 28034

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Changhua Christian Hospital

Changhua, 500

Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Taipei Veterans General Hospital

Taipei, 112

Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, 33382

Taiwan

Addenbrooke's Hospital

Cambridge, CB2 0QQ

United Kingdom

The Royal Surrey County Hospital NHS Foundation Trust

Guildford, GU2 7XX

United Kingdom

Royal Marsden Hospital (Sutton)

London, SM2 5PT

United Kingdom

Royal Marsden Hospital

London, SW3 6JJ

United Kingdom

Imperial College London and Imperial College Healthcare NHS Trust

London, W12 0HS

United Kingdom

University College London Hospitals

London, W1T 7HA

United Kingdom

The Christie Nhs Foundation Trust

Manchester, M20 4BX

United Kingdom