Phase
Condition
Lung Cancer
Head And Neck Cancer
Carcinoma
Treatment
Amivantamab
Carboplatin
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have histologically or cytologically confirmed recurrent/metastatic head and necksquamous cell carcinoma (R/M HNSCC) that is considered incurable by local therapies.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, oralcavity, 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 ofprogrammed cell death ligand 1 (PD-L1) status, if available; Cohort 4: (a) Patientsmust have primary tumor location in oropharynx. Unknown primary tumors are notincluded (b) Primary tumor must be HPV-positive, confirmed by positive p16 test orhigh-risk human papillomavirus (HPV) in-situ hybridization (ISH) in tissue (currentor archival) (c) Participants must provide local testing results of PD-L1 status, ifavailable; Cohort 5 (a) The eligible primary tumor locations are the oropharynx,oral cavity, hypopharynx, or larynx; (b) 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; (c) Participants must provide local testing results ofPD-L1 status
Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according toRECIST version 1.1. Participants in Cohort 3A must have evaluable disease (definedas having at least 1 non-target lesion according to RECIST version 1.1
Toxicities from previous anticancer therapies should have resolved to baselinelevels or to Grade 1 or less prior to the first dose of study treatment (except foralopecia or post-radiation skin changes [any grade], Grade less than or equal to [<=]2 peripheral neuropathy and Grade <=2 hypothyroidism stable on hormonereplacement)
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
Connect with a study center
Beijing Cancer Hospital of Peking University
Beijing, 100142
ChinaActive - Recruiting
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, 610041
ChinaActive - Recruiting
Linyi Cancer Hospital
Linyi, 276002
ChinaActive - Recruiting
Fudan Cancer Hospital
ShangHai, 200032
ChinaActive - Recruiting
Shanghai East Hospital
Shanghai, 200120
ChinaActive - Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022
ChinaActive - Recruiting
Institut Sainte Catherine
Avignon Cedex 9, 84918
FranceActive - Recruiting
Centre Oscar Lambret
Lille, 59020
FranceActive - Recruiting
CHU Nantes
Nantes Cedex 1, 44000
FranceActive - Recruiting
Institut Curie
PARIS Cedex 5, 75248
FranceActive - Recruiting
Gustave Roussy
Villejuif Cedex, 94805
FranceActive - Recruiting
Universitaetsklinikum Essen
Essen, 45147
GermanyActive - Recruiting
Universitaetsklinikum Leipzig
Leipzig, 04103
GermanyActive - Recruiting
Klinikum der Landeshauptstadt Stuttgart
Stuttgart, 70174
GermanyActive - Recruiting
Aichi Cancer Center
Nagoya, 464-8681
JapanActive - Recruiting
Tokyo Medical University Hospital
Tokyo, 160-0023
JapanActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofActive - Recruiting
Pantai Hospital Kuala Lumpur
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214
PolandActive - Recruiting
Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
Gliwice, 44 101
PolandActive - Recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warszawa, 02 781
PolandActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, 08908
SpainActive - Recruiting
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
SpainActive - Recruiting
Changhua Christian Hospital
ChangHua, 500
TaiwanActive - Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, 833
TaiwanActive - Recruiting
Chang Kung Memorial Hospital
Kaohsiung City, 833
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 100
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 112
TaiwanActive - Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, 33382
TaiwanActive - Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX
United KingdomActive - Recruiting
Imperial College London and Imperial College Healthcare NHS Trust
London, W12 0HS
United KingdomActive - Recruiting
Royal Marsden Hospital
London, SW3 6JJ
United KingdomActive - Recruiting
University College London Hospitals
London, W1T 7HA
United KingdomActive - Recruiting
The Christie Nhs Foundation Trust
Manchester, M20 4BX
United KingdomActive - Recruiting
Royal Marsden Hospital
Sutton, SM2 5PT
United KingdomActive - Recruiting
University of California at San Diego Moores Cancer Center
La Jolla, California 92093
United StatesActive - Recruiting
University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06520
United StatesActive - Recruiting
The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
United StatesActive - Recruiting
University of Maryland School of Medicine
Baltimore, Maryland 21201
United StatesActive - Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201 2013
United StatesActive - Recruiting
Washington University School Of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22903
United StatesActive - Recruiting
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesActive - Recruiting
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