Image

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

Recruiting
18 years of age
Both
Phase 1/2

Powered by AI

Overview

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.

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

Study details

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

NCT06385080

Janssen Research & Development, LLC

25 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.