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 February 21, 2025

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61186372HNC2002

OVERVIEW

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

1
Sites
19 Sites
Status

Recruiting

SUMMARY

The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel 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: (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
* Participants in Cohorts 1, 2, and 3B 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

Country (5)	City or Province (19)	Status
United States	New Haven Yale Cancer Center	RECRUITING
United States	Chicago The University of Chicago Medical Center (UCMC)	RECRUITING
United States	Detroit Karmanos Cancer Institute	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	Kaohsiung City Chang Kung Memorial 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

Geo Locations

41.30815, -72.92816

41.85003, -87.65005

42.33143, -83.04575

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

22.61626, 120.31333

25.04776, 121.53185

24.95233, 121.20193

52.2, 0.11667

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Corresponds to individual site.

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