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Monoclonal Antibodies

Magrolimab + Cetuximab + Pembrolizumab/Docetaxel for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Renata Ferrarotto, M D

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have a diagnosis of recurrent or metastatic oropharynx, oral cavity, hypopharynx, or larynx squamous cell carcinoma (HNSCC), not amenable to curative-intent local therapy with known PD-L1 CPS determined by an FDA-approved test.

Male or female ≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial will study if magrolimab, with other drugs, can treat head and neck cancer and its safety.

Who is the study for?

Adults over 18 with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) not suitable for curative treatment, who haven't had systemic therapy in the recurrent/metastatic setting or have had up to two lines excluding docetaxel but including anti-PD1. They must be able to perform daily activities with minimal assistance (ECOG status of 0 or 1), have acceptable organ function tests, agree to use contraception, and provide a tumor tissue sample.Check my eligibility

What is being tested?

The trial is testing magrolimab's effectiveness combined with cetuximab and either pembrolizumab or docetaxel in controlling HNSCC. The safety profile of magrolimab will also be evaluated. Participants are divided into groups based on their previous treatments and PD-L1 CPS scores, receiving these drugs accordingly.See study design

What are the potential side effects?

Potential side effects include immune-related reactions that can affect organs, infusion-related symptoms like fever or chills, fatigue, skin reactions from cetuximab such as acne-like rash; pembrolizumab may cause lung inflammation; docetaxel can lead to hair loss and nail changes.

Eligibility Criteria

Inclusion Criteria

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

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My cancer in the throat or mouth area is spreading and cannot be cured with surgery or radiation, and it has been tested for PD-L1.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My hemoglobin level is at least 9 g/dL, possibly after a transfusion.

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My kidney function, measured by creatinine or filtration rate, is within the required range.

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I don't have an active autoimmune disease or known allergies to pembrolizumab, cetuximab, docetaxel, or magrolimab.

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I've had 1-2 treatments for my cancer that has returned or spread, excluding docetaxel, and my cancer got worse or I couldn't tolerate the side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment3 Interventions

Participants will receive magrolimab and cetuximab along with docetaxel.

Group II: Cohort AExperimental Treatment3 Interventions

Participants will receive magrolimab and cetuximab along with pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Magrolimab

2021

Completed Phase 2

~170

cetuximab

2000

Completed Phase 3

~7290

Docetaxel

1995

Completed Phase 4

~5620

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,724 Total Patients Enrolled

Gilead SciencesIndustry Sponsor

1,082 Previous Clinical Trials

842,784 Total Patients Enrolled

Renata Ferrarotto, M DPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

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

What risk is associated with Cohort A for participants?

"Power's team has rated Cohort A with a safety score of 2, as this Phase 2 trial does not yet have access to efficacy data."

Answered by AI

Is participation in this trial open to the public now?

"According to clinicaltrials.gov, the trial published on February 28th 2024 is no longer recruiting any further participants. Despite this setback, there are still 2774 other medical studies actively looking for candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma

2023. "Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046482.