Testing amivantamab for recurrent or metastatic head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and preliminary effectiveness of amivantamab, both alone and in combination with other treatments like pembrolizumab, paclitaxel, and carboplatin, in patients with recurrent or metastatic head and neck squamous cell carcinoma. It aims to determine the recommended Phase 2 combination dose for amivantamab with paclitaxel. Participants will be monitored for their response to these treatments and any associated side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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

Where it's running

• University of Colorado Denver Anschultz Medical Campus
  Aurora, Colorado, United States Recruiting
• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• The University of Chicago Medical Center (UCMC)
  Chicago, Illinois, United States Recruiting
• University of Maryland School of Medicine
  Baltimore, Maryland, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• University of Michigan Rogel Cancer Center
  Ann Arbor, Michigan, United States Recruiting

+6 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Amivantamab added to pembrolizumab and platinum chemotherapy versus pembrolizumab with platinum/5‑FU for recurrent/metastatic head and neck squamous cell carcinoma

  This trial will see if adding amivantamab to pembrolizumab and platinum‑based chemotherapy helps adults with recurrent or metastatic head and neck squamous cell carcinoma who have not yet had systemic treatment in the metastatic setting.

  Recruiting at 205 sites Phase 3 Janssen Research & Development, LLC · Chandler, Arizona and 204 other locations · NCT07276399

• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

  This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.

  Recruiting Phase 1 Metaclipse Therapeutics Corporation · Houston, Texas · NCT07898124

• Amivantamab with intrathecal pemetrexed for leptomeningeal metastasis from EGFR-mutated lung adenocarcinoma

  This study tests whether giving amivantamab with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung cancer.

  Recruiting Phase 1/2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07744529

• Amivantamab with Lazertinib or Chemotherapy before surgery in EGFR-mutated NSCLC

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  Recruiting at 27 sites Phase 2 Janssen Research & Development, LLC · Duarte, California and 26 other locations · NCT07586202

• Amivantamab with platinum chemotherapy for metastatic EGFR‑mutant non‑small cell lung cancer

  This study will try giving amivantamab together with platinum chemotherapy to adults with metastatic NSCLC who have specific EGFR mutations to see how long their cancer stays controlled and how safe the treatment is.

  Recruiting at 11 sites Groupe Francais De Pneumo-Cancerologie · Aix-en-Provence and 15 other locations · NCT07563205

• Iparomlimab plus tuvonralimab, with or without chemotherapy, for second-line and later recurrent or metastatic head and neck squamous cell carcinoma

  This will try whether combining two antibodies, iparomlimab and tuvonralimab, with or without chemotherapy helps people with recurrent or metastatic head and neck squamous cell carcinoma whose cancer progressed after at least one systemic treatment.

  Recruiting The Second Affiliated Hospital of Hainan Medical University · Haikou, Hainan · NCT07546383

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.