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Chemotherapy

5-Azacytidine + Nivolumab for Squamous Cell Carcinoma

Phase < 1

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Increased response for combination therapy compared with either monotherapy

Secondary outcome measures

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

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 / 5Eligibility criteria met

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Who is running the clinical trial?

Barbara BurtnessLead Sponsor

Barbara Burtness, MDPrincipal InvestigatorYale University

2 Previous Clinical Trials

27 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being granted admittance to this experiment?

"Affirmative. The information stored on clinicaltrials.gov suggests that at this time, the trial is searching for 50 participants from a single medical centre. This study was first posted on March 23rd 2023 and most recently updated on April 19th 2023."

Answered by AI

Are recruitment efforts still underway for this research project?

"As evidenced on clinicaltrials.gov, this medical trial is currently open for recruitment with the first posting beginning on March 23rd 2023 and most recent edits made April 19th of the same year."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer

Ang, K. Kian, Jonathan Harris, Richard Wheeler, Randal Weber, David I. Rosenthal, Phuc Felix Nguyen-Tân, William H. Westra, et al.. 2010. “Human Papillomavirus and Survival of Patients with Oropharyngeal Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0912217.

clinicaltrials.govStudy

5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC

Barbara Burtness 2023. "5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05317000.

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