Amivantamab Combinations for Head and Neck Cancer
(OrigAMI-4 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug called amivantamab alone and with two other drugs, pembrolizumab and paclitaxel. It targets patients with head and neck cancer that has come back or spread. Amivantamab blocks signals that help cancer grow, pembrolizumab helps the immune system fight cancer, and paclitaxel stops cancer cells from dividing. Pembrolizumab has shown benefits when used with chemotherapy.
Will I have to stop taking my current medications?
The trial requires that you stop taking any prior chemotherapy, targeted cancer therapy, immunotherapy, or investigational anticancer agents at least 2 weeks or 4 half-lives before starting the study treatment, with a maximum washout period of 28 days. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What makes the drug Amivantamab unique for head and neck cancer?
What data supports the effectiveness of the drug combination including Amivantamab for head and neck cancer?
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for people with recurrent or metastatic head and neck cancer, including squamous cell carcinoma. Participants should have a type of cancer that has returned after treatment or spread to other parts of the body.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive amivantamab monotherapy or in combination with other agents such as pembrolizumab, paclitaxel, and carboplatin
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Paclitaxel
- Pembrolizumab
Amivantamab is already approved in United States, European Union for the following indications:
- Locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
- Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations
- Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University