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Monoclonal Antibodies

Cemiplimab + Chemotherapy for Head and Neck Cancer

Phase 1

Recruiting

Led By Krzysztof Misiukiewicz, MD

Research Sponsored by Krzysztof Misiukiewicz

Eligibility Criteria Checklist

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

Must have

A pretreatment biopsy of the primary site sufficient for immune studies is required

Patients with stage III or IV, previously untreated, non-metastatic, locally advanced HNSCC (patients may have had previous surgery, but not chemotherapy or radiotherapy)

Must not have

Grade 2 peripheral neuropathy

History of cerebrovascular accident (CVA) within 12 months prior to registration or that is not stable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of cycle 3 (each cycle is 21 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combo on patients with a specific type of head and neck cancer to see how safe and tolerable it is.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in organs; infusion-related reactions; fatigue; digestive issues like nausea; blood disorders including low counts of red cells, white cells or platelets which can increase infection risk; allergic responses especially if there's a known allergy to similar drugs.

Eligibility Criteria

Inclusion Criteria

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

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I have had a biopsy of my cancer that can be used for immune studies.

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I have stage III or IV head and neck cancer that hasn't been treated with chemo or radiotherapy.

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I am 18 years old or older.

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I can provide a biopsy sample from my tumor or lymph node for testing.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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

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

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I have a history of Hepatitis C, HIV, certain autoimmune diseases, or have had a major organ transplant.

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I have an active seizure disorder.

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I have a history of chronic diarrhea or colitis.

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My heart condition is under control.

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I have lost more than 20% of my weight in the last 3 months due to a serious illness.

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I have no GI issues that prevent me from taking pills or affect food absorption.

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I have not had chemotherapy, radiotherapy, or biologic treatments for cancer, except for certain skin cancers or cervical pre-cancer.

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I have previously received immunotherapy.

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I have been treated with PI3K inhibitors before.

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I have had pneumonitis before.

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My brain cancer is causing symptoms, needs steroids, or was treated with radiation recently.

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I am taking 1.5mg or more of dexamethasone daily.

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I do not have any serious illnesses that could stop me from participating in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of cycle 3 (each cycle is 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of cycle 3 (each cycle is 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 3 (each cycle is 21 days) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose-limiting toxicity (DLT)

Secondary study objectives

Adverse events during induction therapy

Alkaline phosphatase (ALP)

Bicarbonate (CO2)

+13 more

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Subcutaneous abscess

13%

Diarrhoea

13%

Hyperthyroidism

13%

Nausea

13%

Constipation

13%

Infusion related reaction

13%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy to Cemiplimab*

Cemiplimab

Chemotherapy*

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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Docetaxel

1995

Completed Phase 4

~6550