A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer (OrigAMI-4)

Last Updated May 17, 2025

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61186372HNC2002

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 1

1
Sites
52 Sites
Status

Recruiting

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.

CONDITIONS

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

ELIGIBILITY

Inclusion Criteria:

* Have histologically or cytologically confirmed recurrent/metastatic head and neck squamous 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, 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: (a) Patients must have primary tumor location in oropharynx. Unknown primary tumors are not included (b) 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) (c) Participants must provide local testing results of PD-L1 status, if available; Cohort 5 (a) The eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx, or larynx; (b) 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; (c) Participants must provide local testing results of PD-L1 status
* Participants in Cohorts 1, 2, 3B, 4 and 5 must have measurable disease according to RECIST version 1.1. Participants in Cohort 3A must have evaluable disease (defined as having at least 1 non-target lesion according to RECIST version 1.1
* 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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, South Korea, Malaysia, Taiwan, United Kingdom, France, Germany, Poland, Spain, China, Japan

Country (11)	City or Province (52)	Status
United States	New Haven Yale Cancer Center	RECRUITING
United States	Chicago The University of Chicago Medical Center (UCMC)	RECRUITING
United States	Saint Louis Washington University School Of Medicine	RECRUITING
United States	Cleveland Cleveland Clinic	RECRUITING
United States	Salt Lake City University of Utah Huntsman Cancer Institute	RECRUITING
United States	Fairfax Virginia Cancer Specialists	RECRUITING
South Korea	Seoul Seoul National University Hospital	RECRUITING
South Korea	Seoul Severance Hospital Yonsei University Health System	RECRUITING
South Korea	Seoul Asan Medical Center	RECRUITING
South Korea	Seoul Samsung Medical Center	RECRUITING
Malaysia	Kuala Lumpur Pantai Hospital Kuala Lumpur	RECRUITING
Malaysia	Kuala Lumpur University Malaya Medical Centre	RECRUITING
Taiwan	ChangHua Changhua Christian Hospital	RECRUITING
Taiwan	Taipei National Taiwan University Hospital	RECRUITING
Taiwan	Taipei Taipei Veterans General Hospital	RECRUITING
Taiwan	Taoyuan Linkou Chang Gung Memorial Hospital	RECRUITING
United Kingdom	Cambridge Addenbrooke's Hospital	RECRUITING
United States	La Jolla University of California at San Diego Moores Cancer Center	RECRUITING
United States	Aurora University of Colorado Denver Anschultz Medical Campus	RECRUITING
United States	Baltimore University of Maryland School of Medicine	RECRUITING
United States	Ann Arbor University of Michigan Rogel Cancer Center	RECRUITING
United States	Detroit Karmanos Cancer Institute	RECRUITING
United States	New Brunswick Rutgers Cancer Institute of New Jersey	RECRUITING
United States	Chapel Hill University of North Carolina at Chapel Hill	RECRUITING
United States	Charlottesville University of Virginia	RECRUITING
France	Avignon Cedex 9 Institut Sainte Catherine	RECRUITING
France	Lille Centre Oscar Lambret	RECRUITING
France	Nantes Cedex 1 CHU Nantes	RECRUITING
France	PARIS Cedex 5 Institut Curie	RECRUITING
France	Villejuif Cedex Gustave Roussy	RECRUITING
Germany	Essen Universitaetsklinikum Essen	RECRUITING
Germany	Leipzig Universitaetsklinikum Leipzig	RECRUITING
Germany	Stuttgart Klinikum der Landeshauptstadt Stuttgart	RECRUITING
Poland	Gdansk Uniwersyteckie Centrum Kliniczne	RECRUITING
Poland	Gliwice Centrum Onkologii Instytut im M Sklodowskiej Curie Oddzial w Gliwicach	RECRUITING
Spain	Barcelona Hosp Univ Vall D Hebron	RECRUITING
Spain	Barcelona Inst. Cat. Doncologia-H Duran I Reynals	RECRUITING
Spain	Madrid Hosp. Univ. Ramon Y Cajal	RECRUITING
Spain	Madrid Hosp. Univ. 12 de Octubre	RECRUITING
United Kingdom	Guildford The Royal Surrey County Hospital NHS Foundation Trust	RECRUITING
United Kingdom	London Royal Marsden Hospital	RECRUITING
United Kingdom	London Imperial College London and Imperial College Healthcare NHS Trust	RECRUITING
United Kingdom	London University College London Hospitals	RECRUITING
United Kingdom	Manchester The Christie Nhs Foundation Trust	RECRUITING
United Kingdom	Sutton Royal Marsden Hospital	RECRUITING
China	Beijing Beijing Cancer Hospital of Peking University	RECRUITING
China	Cheng Du Shi West China School of Medicine/West China Hospital, Sichuan University	RECRUITING
China	Shanghai Shanghai East Hospital	RECRUITING
Japan	Nagoya Aichi Cancer Center	RECRUITING
Japan	Tokyo Tokyo Medical University Hospital	RECRUITING
Poland	Warszawa Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy	RECRUITING
Taiwan	Kaohsiung Kaohsiung Chang Gung Memorial Hospital	RECRUITING

Geo Locations

41.30815, -72.92816

41.85003, -87.65005

38.62727, -90.19789

41.4995, -81.69541

40.76078, -111.89105

38.84622, -77.30637

37.566, 126.9784

3.1412, 101.68653

24.07327, 120.56276

25.04776, 121.53185

24.95233, 121.20193

52.2, 0.11667

32.84727, -117.2742

39.72943, -104.83192

39.29038, -76.61219

42.27756, -83.74088

42.33143, -83.04575

40.48622, -74.45182

35.9132, -79.05584

38.02931, -78.47668

43.94834, 4.80892

50.63297, 3.05858

47.21725, -1.55336

48.85341, 2.3488

48.7939, 2.35992

51.45657, 7.01228

51.33962, 12.37129

48.78232, 9.17702

54.35205, 18.64637

50.29761, 18.67658

41.38879, 2.15899

40.4165, -3.70256

51.23536, -0.57427

51.50853, -0.12574

53.48095, -2.23743

51.35, -0.2

39.9075, 116.39723

30.5970699, 104.05106

31.22222, 121.45806

35.18147, 136.90641

35.6895, 139.69171

52.22977, 21.01178

22.61626, 120.31333

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

41.30815, -72.92816

41.85003, -87.65005

38.62727, -90.19789

41.4995, -81.69541

40.76078, -111.89105

38.84622, -77.30637

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

3.1412, 101.68653

3.1412, 101.68653

24.07327, 120.56276

25.04776, 121.53185

25.04776, 121.53185

24.95233, 121.20193

52.2, 0.11667

32.84727, -117.2742

39.72943, -104.83192

39.29038, -76.61219

42.27756, -83.74088

42.33143, -83.04575

40.48622, -74.45182

35.9132, -79.05584

38.02931, -78.47668

43.94834, 4.80892

50.63297, 3.05858

47.21725, -1.55336

48.85341, 2.3488

48.7939, 2.35992

51.45657, 7.01228

51.33962, 12.37129

48.78232, 9.17702

54.35205, 18.64637

50.29761, 18.67658

41.38879, 2.15899

41.38879, 2.15899

40.4165, -3.70256

40.4165, -3.70256

51.23536, -0.57427

51.50853, -0.12574

51.50853, -0.12574

51.50853, -0.12574

53.48095, -2.23743

51.35, -0.2

39.9075, 116.39723

30.5970699, 104.05106

31.22222, 121.45806

35.18147, 136.90641

35.6895, 139.69171

52.22977, 21.01178

22.61626, 120.31333

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