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A Study of Amivantamab for Head and Neck Cancer

This study is looking at amivantamab, alone or with other treatments like pembrolizumab, paclitaxel, and carboplatin, for people with head and neck squamous cell carcinoma (HNSCC). Researchers want to see how safe these treatments are and how well they work. You might be eligible if you have recurrent/metastatic HNSCC that can't be cured by local treatments, or locally advanced HNSCC that can be removed by surgery. The study will measure how many participants respond to the treatment, with follow-up for up to 2 years and 2 months. The current status of this study is unclear.

Study design
This interventional study plans to enroll 287 participants. It is exploring different combinations of amivantamab with other drugs.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants in most groups will be followed for up to 2 years and 2 months to measure how well the treatment works. For one group, safety will be monitored for up to 2 years and 1 month.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06385080

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~287 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:AmivantamabPembrolizumabPaclitaxelCarboplatin

At a glance

Recruiting sites
52 of 56 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate
Measured over 2 years and 2 months
+3 more outcomes measured

Conditions

Squamous Cell Carcinoma of Head and Neck

Explore related trials

Head and Neck Squamous Cell CarcinomaCDKN2A wt AlleleHPV

Where it's being run

56 sites across 23 states
United Kingdom7
China6
France5
Taiwan5
South Korea4
Spain4
Germany3
Poland3

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Cohorts 1, 2, 3B, 4 and 5: Objective Response Rate2 years and 2 months

    ORR is defined as the proportion of participants who achieve either a partial response (PR) or complete response (CR), as defined by investigator assessment using Response Criteria in Solid Tumors (RECIST) version 1.1.

  • Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT)Up to 21 days

    Number of participants with DLTs will be reported. A DLT is defined as any of the following: treatment delay of greater than (\>) 28 days due to unresolved toxicity, non-hematologic toxicity of Grade 3 or higher, hematologic toxicity of Grade 4 neutropenia persisting for \>7 days or Grade 3 or higher thrombocytopenia with clinically significant bleeding or neutropenic fever of any grade, and liver enzyme elevation.

  • Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity2 years and 1 month

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity of TEAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (mild) to Grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening, and Grade 5= death related to adverse event.

  • Cohort 6: Major Pathologic Response (MPR)2 years and 2 months

    The participants who achieve MPR at the time of surgery.