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Monoclonal Antibodies

Cohort 3A (Dose Confirmation): Amivantamab + Paclitaxel for Head and Neck Squamous Cell Carcinoma (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years and 2 months

Awards & highlights

OrigAMI-4 Trial Summary

This trial will test the safety and effectiveness of a drug called amivantamab alone, amivantamab with pembrolizumab, and amivantamab with paclitaxel

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.Check my eligibility

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.See study design

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.

OrigAMI-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organs and bone marrow are functioning well without recent medical help.

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My oropharyngeal tumor is p16 negative.

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I can carry out all my daily activities without help.

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My cancer originates in the throat, mouth, or voice box.

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My cancer is a type of head and neck cancer that has returned or spread and cannot be cured with surgery or radiation.

OrigAMI-4 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years and 2 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

OrigAMI-4 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

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

~5380

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

977 Previous Clinical Trials

6,384,532 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

746 Previous Clinical Trials

3,960,110 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants in this clinical trial at the moment?

"Yes, information available on clinicaltrials.gov shows that this study is currently seeking participants. This trial was initially listed on April 22nd, 2024, with the most recent update made on April 23rd, 2024. Recruitment aims to enroll a total of 117 individuals at a single site."

Answered by AI

What is the total number of participants enrolled in this research endeavor?

"Yes, data on clinicaltrials.gov indicates that this trial is currently open for enrollment. The study was first listed on April 22nd, 2024, and underwent its most recent update on April 23rd, 2024. Recruitment aims to include a total of 117 participants at one site."

Answered by AI

What are the main goals that this investigation aims to achieve?

"The primary endpoint of this clinical investigation, to be evaluated over a span of 2 years and 2 months, pertains to Cohort 3A: The incidence of Dose-Limiting Toxicities (DLT) among participants. Secondary endpoints encompass various parameters like Cohort 1: Time taken for Amivantamab to reach its peak concentration in the bloodstream (Tmax), defined as the duration until maximum serum levels are observed., along with outcomes such as Duration of Response (DoR) across Cohorts 1, 2, and 3B - indicating the time from initial documented response (PR or CR)"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06385080.

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