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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of toxicities graded according to NCI CTCAE

Trial Design

1Treatment groups
Experimental Treatment
Group I: Head and Neck Squamous Cell Cancer/HNSCCExperimental Treatment7 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Post-operative radiation therapy
2003
Completed Phase 2
~50
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Docetaxel
1995
Completed Phase 4
~5620
Cetuximab
2011
Completed Phase 3
~2480
Cemiplimab
2015
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,939 Previous Clinical Trials
588,826 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
628 Previous Clinical Trials
382,212 Total Patients Enrolled
Lara Dunn, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04722523 — Phase 1
Head and Neck Cancers Research Study Groups: Head and Neck Squamous Cell Cancer/HNSCC
Head and Neck Cancers Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04722523 — Phase 1
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04722523 — Phase 1
~11 spots leftby Jun 2026
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