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Chemotherapy

5-Azacytidine + Nivolumab for Squamous Cell Carcinoma

Phase 2

Recruiting

Led By Barbara Burtness, MD

Research Sponsored by Barbara Burtness

Eligibility Criteria Checklist

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

Must have

Patients with resectable histologically or cytologically confirmed squamous cell carcinoma of the oropharynx

Age > 18 years

Must not have

Medical contraindication to transoral surgery

Full dose anticoagulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; 14-30 days prior to surgery, 30 and 90 days post resection surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate if 5-AZA will make HPV-associated head and neck cancer more sensitive to nivolumab immunotherapy.

Who is the study for?

This trial is for adults with resectable HPV-associated squamous cell carcinoma of the oropharynx, without prior systemic therapy or radiation. Participants must have certain blood counts and organ function levels within normal ranges, not be on full dose anticoagulation, and women must not be pregnant or breastfeeding.

What is being tested?

The study tests if 5-Azacytidine (a chemotherapy drug) can make head and neck cancer more responsive to Nivolumab (an immunotherapy). Patients will receive either one of these drugs alone or in combination to assess their effectiveness against this type of cancer.

What are the potential side effects?

Potential side effects include immune system reactions that could affect various organs, typical chemotherapy-related issues like nausea and fatigue, as well as possible skin reactions at injection sites.

Eligibility Criteria

Inclusion Criteria

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

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I have a type of throat cancer that can be surgically removed.

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I am older than 18 years.

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My cancer is HPV-related, confirmed by a specific p16 test.

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I am fully active or can carry out light work.

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My throat cancer is in the early to mid stages and has not spread widely.

Exclusion Criteria

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

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I cannot have surgery through the mouth due to health reasons.

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I am on a full dose of blood thinner medication.

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I am unable to understand and agree to the study's details.

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I do not have an active autoimmune disease, haven't used high-dose steroids recently, and am not allergic to study drugs.

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I have had previous treatments like surgery, radiation, or medication for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; 14-30 days prior to surgery, 30 and 90 days post resection surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; 14-30 days prior to surgery, 30 and 90 days post resection surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 14-30 days prior to surgery, 30 and 90 days post resection surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Increased response for combination therapy compared with either monotherapy

Secondary study objectives

Increased activated T cell infiltration in 5-Aza containing arms compared to Nivolumab monotherapy arm

Occurrence of toxicity

Secondary correlative evidence of anti-tumor response

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C: Combination 5-azacytidine and NivolumabExperimental Treatment1 Intervention

Patients will receive 5-azacytidine 75mg/m2 IV daily x 5. Treatment must begin on a Monday. 5-azacytidine will be given prior to nivolumab on day 2. Patients will receive anti-emetic premedication with prochlorperazine 10 mg IV, a 5HT3 antagonist per institutional guidelines, aprepitant or fos-aprepitant, and prn lorazepam on day 1. Day 2-5 patients will receive prochlorperazine 10 mg IV. Subsequent day 5HT3 antagonist therapy will be determined per institutional guidelines, as recommendations vary based on the half-life of the agent chosen. PRN lorazepam can be used days 2-5. Nivolumab will be administered at a dose of 240 mg IV day 2 and day 16. No additional premedication will be given on day 16. Dexamethasone will be reserved for patients whose nausea and/or emesis is not controlled by the initial regimen. Surgery will be scheduled in the period of day 17 through day 18.

Group II: Arm A: 5-azacytidineActive Control1 Intervention

Patients will receive 5-azacytidine 75mg/m2 IV daily x 5. Treatment must begin on a Monday. Patients will receive anti-emetic premedication with prochlorperazine 10 mg IV, a 5HT3 antagonist per institutional guidelines, aprepitant or fos-aprepitant, and prn lorazepam on day 1. Day 2-5 patients will receive prochlorperazine 10 mg IV. Subsequent day 5HT3 antagonist therapy will be determined per institutional guidelines, as recommendations vary based on the half-life of the agent chosen. PRN lorazepam can be used days 2-5. Dexamethasone will be reserved for patients who are not controlled by the initial regimen. A single cycle of 5-azacytidine will be administered and the patient scheduled for surgery in the period of day 16 through day 18.

Group III: Arm B: NivolumabActive Control1 Intervention

Nivolumab will be administered at a dose of 240 mg IV day 1 and day 15. Treatment must be given on a Monday or Tuesday. No premedication will be given. Patients will be observed following the initial dose of nivolumab per institutional Surgery will be scheduled in the period of day 16 through day 18.

0 / 10Eligibility criteria met