← Back to Search

Monoclonal Antibodies

Amivantamab Combinations for Head and Neck Cancer (OrigAMI-4 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ and bone marrow function without recent transfusions or use of granulocyte colony-stimulating factor
Negative p16 status for all participants with an oropharyngeal tumor
Must not have
Untreated brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
Uncontrolled illness including non-infectious interstitial lung disease (ILD)/pneumonitis/pulmonary fibrosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years and 2 months
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
The study tests amivantamab alone, combined with pembrolizumab, and in combination with paclitaxel. It aims to find out how safe these treatments are and how well they work against advanced head and neck cancer.
What are the potential side effects?
Possible side effects include allergic reactions to medication, fatigue, nausea, skin rash, infusion-related reactions from amivantamab or pembrolizumab, and hair loss or nerve damage from paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My organs and bone marrow are functioning well without recent medical help.
Select...
My oropharyngeal tumor is p16 negative.
Select...
I can carry out all my daily activities without help.
Select...
My cancer originates in the throat, mouth, or voice box.
Select...
My cancer is a type of head and neck cancer that has returned or spread and cannot be cured with surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have brain metastases or spinal issues not treated by surgery or radiation.
Select...
I do not have any uncontrolled illnesses like lung scarring or inflammation.
Select...
I have a history of serious heart problems.
Select...
I received radiotherapy for symptom relief within the last week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years and 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT)
Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity
Cohorts 1, 2, and 3B: Objective Response Rate
Secondary study objectives
Cohort 1: Accumulation Ratio (R) of Amivantamab
Cohort 1: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab
Cohort 1: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 3B (Dose Expansion): Amivantamab + PaclitaxelExperimental Treatment2 Interventions
Participants will receive subcutaneous injection of amivantamab at the determined RP2CD in addition to intravenous injection of paclitaxel 175 mg/m\^2 q3w (on Day 1 of each 21-day cycle) as confirmed by SET in Cohort 3A.
Group II: Cohort 3A (Dose Confirmation): Amivantamab + PaclitaxelExperimental Treatment2 Interventions
Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous injection of paclitaxel 175 mg/m\^2 q3w (on Day 1 of each 21-day cycle) in dose confirmation Cohort 3A. The recommended Phase 2 combination dose (RP2CD) of amivantamab will be determined in conjunction with study evaluation team (SET) in this dose confirmation Cohort 3A.
Group III: Cohort 2: Amivantamab + Pembrolizumab (Dose Expansion Including Safety Run-in)Experimental Treatment2 Interventions
Participants will receive subcutaneous injection of amivantamab 1600 mg (2240 mg, if body weight \>=80 kg) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) q1w for the remainder of Cycle 1 (Days 8 and 15), and q3w from Cycle 2 onwards, along with intravenous injection of pembrolizumab 200 mg q3w (on Day 1 of each 21-day cycle).
Group IV: Cohort 1: Amivantamab Monotherapy (Dose Expansion)Experimental Treatment1 Intervention
Participants will receive subcutaneous injection of amivantamab monotherapy 1600 milligrams (mg) (2240 mg, if body weight \>=80 kilograms \[kg\]) on Cycle 1 Day 1 and 2400 mg (3360 mg, if body weight \>=80 kg) once every week (q1w) for the remainder of Cycle 1 (Days 8 and 15), and every 3 weeks (q3w) from Cycle 2 onwards.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5370
Pembrolizumab
2017
Completed Phase 3
~2810

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include targeted therapies, immunotherapies, and chemotherapies. Targeted therapies, such as amivantamab, work by inhibiting specific proteins like EGFR and MET that are involved in tumor growth and survival. This is crucial for HNSCC patients as these receptors are often overexpressed, leading to aggressive tumor behavior. Immunotherapies, like pembrolizumab, enhance the body's immune response against cancer cells by targeting immune checkpoints such as PD-1/PD-L1. Chemotherapies, including agents like paclitaxel, disrupt cell division, leading to cancer cell death. Understanding these mechanisms helps in selecting the most effective treatment strategy, potentially improving outcomes and reducing side effects for HNSCC patients.
In vitro effect of radiation, antibody to epidermal growth factor receptor and Docetaxel in human head and neck squamous carcinoma cells with mutant P53 and over-expressed EGFR.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,003 Previous Clinical Trials
6,397,879 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
769 Previous Clinical Trials
3,973,619 Total Patients Enrolled
~78 spots leftby Jul 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top