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Alkylating agents

Pembrolizumab + CRT for Head and Neck Cancer

Phase 1

Waitlist Available

Led By Steven F Powell, MD

Research Sponsored by Sanford Health

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically-confirmed head and neck squamous cell carcinoma of the oral cavity (excluding lip), oropharynx, hypopharynx, or larynx

Willing to provide tissue from a recently obtained core or excisional biopsy of a tumor lesion

Must not have

Known history of, or any evidence of active, non-infectious pneumonitis

Active autoimmune disease requiring systemic treatment in the past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through day 240 (this time frame allows capturing of aes that occurred up to 90 days after completion of treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination of drugs to treat head and neck cancer. The new combination consists of pembrolizumab, a standard chemotherapy drug, and cisplatin, a radiation therapy. Patients will not be randomized, and all will receive the new combination.

Who is the study for?

This trial is for adults with stage III-IVB head and neck squamous cell carcinoma, who can undergo chemoradiation therapy. They must have good performance status, no prior head and neck radiation, not be on immunosuppressives or have active infections, and agree to use contraception.

What is being tested?

The study tests pembrolizumab combined with standard cisplatin-based chemoradiotherapy (CRT) in patients. It's a single-arm trial where all participants receive the same treatment without randomization to evaluate safety and effectiveness.

What are the potential side effects?

Possible side effects include immune-related reactions due to pembrolizumab, such as inflammation of organs; infusion reactions; fatigue; nausea from cisplatin; skin changes from radiation; plus increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a type of throat or mouth cancer, not including the lip.

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I am willing to give a tissue sample from a recent biopsy.

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My cancer is at an advanced stage (stage III, IVA, or IVB).

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am at least 18 years old.

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I am a candidate for treatment aimed at curing my cancer using both chemotherapy and radiation at the same time.

Exclusion Criteria

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

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I have or had lung inflammation not caused by an infection.

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I have been treated for an autoimmune disease in the last 2 years.

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I have had radiation therapy to my head or neck.

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My cancer has spread to distant parts of my body.

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I have an active tuberculosis infection.

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I have previously received specific anti-cancer treatments.

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I have cancer that has spread to my brain or spinal cord.

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I have not taken steroids or immunosuppressants in the last 7 days.

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I am currently on medication for an infection.

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I have previously been treated with specific medications.

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I have a history of HIV or active Hepatitis B or C.

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

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I have another cancer that is getting worse or needs treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through day 240 (this time frame allows capturing of aes that occurred up to 90 days after completion of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through day 240 (this time frame allows capturing of aes that occurred up to 90 days after completion of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 240 (this time frame allows capturing of aes that occurred up to 90 days after completion of treatment) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse Events Will be Assessed and Graded Using CTCAE 4.0. Occurrences With Max Grade and Percentage/Number of Participants Affected by AEs Will be Provided.

Secondary study objectives

Evaluation of the Efficacy of Pembrolizumab Given in Combination With Definitive CRT by Determining the Number of Participants With Complete Response at Treatment End (Day 150)