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Chemotherapy

Cemiplimab + Chemotherapy/Immunotherapy for Head and Neck Cancer

Phase 1

Recruiting

Led By Lara Dunn, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Adequate hepatic function: Total bilirubin <1.5 x upper limit of normal ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both < 3 x ULN, Alkaline phosphatase (ALP) <2.5 x ULN Note: For patients with Gilbert syndrome, total bilirubin <3x ULN. Upper central must be documented appropriately as past medical history

Serum creatinine <1.5 upper limit of normal (ULN) or estimated creatinine clearance (CrCl) >30 mL/min

Must not have

Prior radiation and systemic therapy for a head and neck cancer

Receipt of live attenuated vaccine within 30 days prior initiating treatment on study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new immunotherapy drug combo can replace radiation for head and neck cancer patients.

Who is the study for?

This trial is for adults over 18 with certain types of head and neck cancer that can be surgically removed. They must have good blood counts, organ function, no distant metastasis, and not have had prior radiation or systemic therapy for the cancer. Excluded are those with recent serious infections, autoimmune disorders treated in the last 5 years (with some exceptions), live vaccines taken within a month, HIV/HBV/HCV unless controlled, history of immune-related pneumonitis or solid organ transplant.

What is being tested?

The study tests if combining standard chemotherapy with immunotherapy drugs cetuximab and cemiplimab before surgery is safe and effective enough to potentially skip post-surgery radiation. Participants will receive this combination treatment to see how well it works against head and neck cancers.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in various organs, infusion reactions from receiving drugs through a vein, fatigue, skin rashes like acne or dry skin due to cetuximab; cemiplimab may cause similar issues along with potential impacts on liver enzymes.

Eligibility Criteria

Inclusion Criteria

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

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My liver tests are within normal limits, or slightly above if I have Gilbert syndrome.

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My kidney function is within the normal range.

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My cancer is at a stage where surgery followed by radiation or chemotherapy is recommended, without spread to distant parts of the body.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My cancer is a type of squamous cell carcinoma located in the head or neck area.

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I am eligible for surgery.

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I have head and neck cancer that can be removed by surgery and I haven't had radiation or systemic therapy before.

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My condition can be treated with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation and medication treatment for head or neck cancer.

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I have not received a live vaccine in the last 30 days.

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My oral cancer cannot be removed with surgery or I am not fit for surgery.

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I have had a stem cell transplant from a donor or from myself.

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I have a lung condition that needed strong medication to manage.

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I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.

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I haven't been hospitalized for an infection needing IV antibiotics in the last 2 weeks.

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I am allergic to ingredients in the cemiplimab medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of toxicities graded according to NCI CTCAE

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Secondary CohortExperimental Treatment3 Interventions

Participants with locally advanced, resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible.

Group II: Head and Neck Squamous Cell Cancer/HNSCCExperimental Treatment8 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5370

Post-operative radiation therapy

2003

Completed Phase 2