Phase
Condition
Carcinoma
Lung Cancer
Head And Neck Cancer
Treatment
Amivantamab
Carboplatin
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Beijing Cancer Hospital of Peking University
Beijing, 100142
ChinaActive - Recruiting
Beijing Cancer Hospital of Peking University
Beijing 1816670, 100142
ChinaSite Not Available
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, 610041
ChinaActive - Recruiting
Linyi Cancer Hospital
Linyi, 276002
ChinaActive - Recruiting
Linyi Cancer Hospital
Linyi 1803318, 276002
ChinaSite Not Available
Fudan Cancer Hospital
Shanghai, 200032
ChinaActive - Recruiting
Shanghai East Hospital
Shanghai, 200120
ChinaActive - Recruiting
Fudan Cancer Hospital
Shanghai 1796236, 200032
ChinaSite Not Available
Shanghai East Hospital
Shanghai 1796236, 200120
ChinaActive - Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, 430022
ChinaActive - Recruiting
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan 1791247, 430022
ChinaSite Not Available
Institut Sainte Catherine
Avignon, 84918
FranceActive - Recruiting
Institut Sainte Catherine
Avignon 3035681, 84918
FranceSite Not Available
Institut Sainte Catherine
Avignon Cedex 9, 84918
FranceSite Not Available
Centre Oscar Lambret
Lille, 59000
FranceActive - Recruiting
Centre Oscar Lambret
Lille 2998324, 59000
FranceSite Not Available
CHU Nantes
Nantes, 44000
FranceActive - Recruiting
CHU Nantes
Nantes 2990969, 44000
FranceSite Not Available
CHU Nantes
Nantes Cedex 1, 44000
FranceSite Not Available
Institut Curie
PARIS Cedex 5, 75248
FranceSite Not Available
Institut Curie
Paris, 75248
FranceActive - Recruiting
Institut Curie
Paris 2988507, 75248
FranceSite Not Available
Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Gustave Roussy
Villejuif 2968705, 94805
FranceSite Not Available
Gustave Roussy
Villejuif Cedex, 94805
FranceSite Not Available
Universitaetsklinikum Essen
Essen, 45147
GermanyActive - Recruiting
Universitaetsklinikum Essen
Essen 2928810, 45147
GermanySite Not Available
Universitaetsklinikum Leipzig
Leipzig, 04103
GermanyCompleted
Universitaetsklinikum Leipzig
Leipzig 2879139, 04103
GermanySite Not Available
Klinikum der Landeshauptstadt Stuttgart
Stuttgart, 70174
GermanyActive - Recruiting
Klinikum der Landeshauptstadt Stuttgart
Stuttgart 2825297, 70174
GermanySite Not Available
Aichi Cancer Center
Nagoya, 464-8681
JapanActive - Recruiting
Aichi Cancer Center
Nagoya 1856057, 464-8681
JapanSite Not Available
Tokyo Medical University Hospital
Tokyo, 160-0023
JapanActive - Recruiting
Tokyo Medical University Hospital
Tokyo 1850147, 160-0023
JapanSite Not Available
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 ofSite Not Available
Pantai Hospital Kuala Lumpur
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
Pantai Hospital Kuala Lumpur
Kuala Lumpur 1735161, 59100
MalaysiaActive - Recruiting
University Malaya Medical Centre
Kuala Lumpur 1735161, 59100
MalaysiaSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk 3099434, 80 214
PolandSite Not Available
Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
Gliwice, 44-102
PolandActive - Recruiting
Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach
Gliwice 3099230, 44-102
PolandSite Not Available
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02 781
PolandActive - Recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw 756135, 02 781
PolandSite Not Available
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warszawa, 02 781
PolandSite Not Available
Asan Medical Center
Seoul, 05505
South KoreaActive - Recruiting
Samsung Medical Center
Seoul, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, 03080
South KoreaActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, 03722
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul 1835848, 03722
South KoreaSite Not Available
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainActive - Recruiting
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona, 08908
SpainActive - Recruiting
Hosp Univ Vall D Hebron
Barcelona 3128760, 08035
SpainActive - Recruiting
Inst. Cat. Doncologia-H Duran I Reynals
Barcelona 3128760, 08908
SpainSite Not Available
Hosp. Univ. 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hosp. Univ. Ramon Y Cajal
Madrid, 28034
SpainActive - Recruiting
Hosp. Univ. 12 de Octubre
Madrid 3117735, 28041
SpainSite Not Available
Hosp. Univ. Ramon Y Cajal
Madrid 3117735, 28034
SpainActive - Recruiting
Changhua Christian Hospital
Changhua, 500
TaiwanActive - Recruiting
Changhua Christian Hospital
Changhua 1993459, 500
TaiwanSite Not Available
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, 833
TaiwanSite Not Available
Chang Kung Memorial Hospital
Kaohsiung City, 833
TaiwanSite Not Available
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
TaiwanActive - Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City 1673820, 833
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 100
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 112
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei 1668341, 100
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei 1668341, 112
TaiwanActive - Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, 33382
TaiwanSite Not Available
Linkou Chang Gung Memorial Hospital
Taoyuan District, 33382
TaiwanActive - Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan District 1667905, 33382
TaiwanSite Not Available
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Addenbrooke's Hospital
Cambridge 2653941, CB2 0QQ
United KingdomSite Not Available
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX
United KingdomActive - Recruiting
The Royal Surrey County Hospital NHS Foundation Trust
Guildford 2647793, GU2 7XX
United KingdomSite Not Available
Imperial College London and Imperial College Healthcare NHS Trust
London, W12 0HS
United KingdomActive - Recruiting
Royal Marsden Hospital
London, SW3 6JJ
United KingdomActive - Recruiting
Royal Marsden Hospital (Sutton)
London, SM2 5PT
United KingdomActive - Recruiting
University College London Hospitals
London, W1T 7HA
United KingdomActive - Recruiting
Imperial College London and Imperial College Healthcare NHS Trust
London 2643743, W12 0HS
United KingdomSite Not Available
Royal Marsden Hospital
London 2643743, SW3 6JJ
United KingdomActive - Recruiting
University College London Hospitals
London 2643743, W1T 7HA
United KingdomActive - Recruiting
The Christie Nhs Foundation Trust
Manchester, M20 4BX
United KingdomActive - Recruiting
The Christie Nhs Foundation Trust
Manchester 2643123, M20 4BX
United KingdomSite Not Available
Royal Marsden Hospital
Sutton, SM2 5PT
United KingdomSite Not Available
Royal Marsden Hospital
Sutton 2636503, SM2 5PT
United KingdomSite Not Available
University of California at San Diego Moores Cancer Center
La Jolla, California 92093
United StatesCompleted
University of California at San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093
United StatesSite Not Available
University of Colorado Denver Anschultz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado Denver Anschultz Medical Campus
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Yale Cancer Center
New Haven, Connecticut 06520
United StatesActive - Recruiting
Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06520
United StatesSite Not Available
The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
United StatesActive - Recruiting
The University of Chicago Medical Center (UCMC)
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
University of Maryland School of Medicine
Baltimore, Maryland 21201
United StatesActive - Recruiting
University of Maryland School of Medicine
Baltimore 4347778, Maryland 4361885 21201
United StatesSite Not Available
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201 2013
United StatesActive - Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201 2013
United StatesSite Not Available
Washington University School Of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School Of Medicine
St Louis, Missouri 63110
United StatesActive - Recruiting
Washington University School Of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesActive - Recruiting
University of Utah Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesActive - Recruiting
Virginia Cancer Specialists
Fairfax, Virginia 22031
United StatesActive - Recruiting
University of Virginia
Charlottesville 4752031, Virginia 6254928 22903
United StatesSite Not Available
Virginia Cancer Specialists
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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