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

Overseen by Renata Ferrarotto, M D

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

To learn if magrolimab, along with a combination of commercially-available drugs (cetuximab, pembrolizumab, and docetaxel) can help to control HNSCC in combination with other drugs. The safety of magrolimab will also be studied.

Research Team

Renata Ferrarotto, M D

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Patient is willing and able to comply with clinic visits and procedures outlined in the study protocol.

Platelets ≥ 100 x 109/mL

My blood clotting time is normal or managed with medication.

Exclusion Criteria

I still have mild side effects from my last treatment.

I may have mild neuropathy, hair loss, or certain lab results but can still qualify for the study.

I have fully recovered from any major surgery before starting treatment.

Treatment Details

Interventions

• Cetuximab (Monoclonal Antibodies)
• Docetaxel (Chemotherapy)
• Magrolimab (Monoclonal Antibodies)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Cohort B Experimental Treatment 3 Interventions

Participants will receive magrolimab and cetuximab along with docetaxel.

Group II: Cohort A Experimental Treatment 3 Interventions

Participants will receive magrolimab and cetuximab along with pembrolizumab.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine