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PD-1 Inhibitor

Pembrolizumab + Radiotherapy for Recurrent Head and Neck Cancer (QUADSHOT Trial)

Phase 2

Recruiting

Led By Christina Henson, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

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

Must have

Age 18 years and older

Pathologically proven diagnosis of squamous cell carcinoma of the head and neck (nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknown primary)

Must not have

Active or prior documented autoimmune disease within the past 2 years

Histologically confirmed other types (Non-SCC) of salivary gland cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a new radiotherapy treatment is safe for patients with recurrent head and neck cancer, and if it is effective in combination with pembrolizumab.

Who is the study for?

Adults with recurrent head and neck squamous cell carcinoma, who have evaluable lesions and whose cancer is not suitable for curative treatment. Participants must be at least six months past any prior radiation therapy, have adequate organ function, agree to use contraception if of reproductive potential, and not have used immunosuppressive medication recently.

What is being tested?

'QUAD SHOT' radiotherapy combined with pembrolizumab is being tested for safety and effectiveness in treating patients with recurrent head and neck cancer. The study aims to see how well these treatments work together.

What are the potential side effects?

Possible side effects include immune system reactions that can affect organs, infusion-related reactions like fever or chills, fatigue, kidney problems from the contrast agent used during scans, skin reactions from radiotherapy, and potential complications related to existing health issues.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have been diagnosed with squamous cell carcinoma in my head or neck.

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I can take care of myself and perform daily activities.

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My head or neck cancer has returned or spread and cannot be cured with surgery or more radiation, and it's been over 6 months since my last radiation treatment.

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My blood tests show enough neutrophils, platelets, and hemoglobin.

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My kidney function is good based on tests.

Exclusion Criteria

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

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I have had an autoimmune disease in the last 2 years.

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My cancer is a non-squamous cell type of salivary gland cancer.

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I had skin cancer (not melanoma) treated and currently show no signs of it.

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I have had severe side effects from previous immunotherapy.

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I do not have any severe illnesses or conditions that are not under control.

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My early-stage cancer was treated and shows no signs of disease.

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I have never been treated with PD-1 or PD-L1 inhibitors.

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I don't have severe side effects from past cancer treatments.

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My prostate cancer is low to intermediate risk and I am on active surveillance.

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I cannot have radiotherapy due to a genetic condition.

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I cannot have IV contrast due to poor kidney function or other reasons.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab + QUADSHOT RadiotherapyExperimental Treatment1 Intervention

Combination Treatment * Pembrolizumab by IV once on day 1 of 21 day cycle, begin 7 days before the first round of QUAD SHOT radiotherapy. * QUAD SHOT radiotherapy twice a day for two days, begin 7 days after the first dose of pembrolizumab; repeat every 28 days for up to 3 rounds. Maintenance Treatment * Pembrolizumab by IV once on day 1 of 21 day cycle * On day 21, if the medical oncologist feels that the patient may safely continue treatment, patient will receive a new 21 days cycle of treatment with pebrolizumab.

0 / 18Eligibility criteria met