Cemiplimab + Chemotherapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byKrzysztof Misiukiewicz, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Krzysztof Misiukiewicz

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this research study is to determine the safety and tolerability of two dosing schedules of cemiplimab given in combination with cisplatin and docetaxel induction chemotherapy (TPI) in patients with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). Cemiplimab is FDA approved for treatment of basal cell and squamous cell carcinoma of the skin as well as non-small cell lung cancer but not for squamous cell carcinoma of head and neck.

Eligibility Criteria

This trial is for adults over 18 with stage III or IV, previously untreated non-metastatic head and neck squamous cell carcinoma. Eligible patients may have had surgery but not chemotherapy or radiotherapy. They must be HPV negative or high-risk HPV positive, have a good performance status (ECOG PS 0-1), adequate organ function, and agree to use effective contraception. Exclusions include significant cardiac disease, psychiatric conditions affecting study compliance, severe allergies to docetaxel, active infections that could interfere with the study, history of certain diseases like colitis or autoimmune disorders (except vitiligo and Hashimoto's thyroiditis), prior immunotherapy treatment, and unstable brain metastases.

Inclusion Criteria

My cancer is in the mouth or throat and is either not caused by HPV or caused by a high-risk HPV type.

Predicted life expectancy >/= 12 weeks

Patients must provide verbal and written informed consent to participate in the study

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Exclusion Criteria

I experience moderate numbness, pain, or tingling in my hands or feet.

I have not had a stroke or my stroke condition has been stable for the last 12 months.

Patients with history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

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Participant Groups

The trial tests two dosing schedules of cemiplimab in combination with cisplatin and docetaxel chemotherapy in patients with locally advanced head and neck cancer. Cemiplimab is approved for skin cancers but its safety for head and neck cancer is being studied here.

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment3 Interventions

* In cohort B first dose of Cemiplimab will be given 7 days prior to TP followed by TP given on days 1,22,43 (+/- 2 days) and Cemiplimab given on days 14, 35, 56 (+/- 2 days). * Patient in cohort B will get 4 doses of Cemiplimab during induction therapy.

Group II: Cohort AExperimental Treatment3 Interventions

* 3 cycles of Cemiplimab-TP induction chemotherapy will be delivered in cohort A. * Cemiplimab-TP chemotherapy will be given every 21 days starting on days 1, 22 and 43, etc. (+ 2 days) with TP given on days 1, 22, and 43 (+/- 2 days) and Cemiplimab given on days 14, 35, 56 (+/- 2 days). * Patients in cohort A will get 3 doses of Cemiplimab during induction therapy.

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

🇪🇺 Approved in European Union as Libtayo for: