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ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck

NCT06357858 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-07-03

No results posted yet for this study

Summary

The goal of this clinical trial is to see if the combination of experimental drug ASTX727 and Nivolumab enhances the antitumor immune response in participants will recurrent or metastatic squamous cell carcinoma of the head and neck.

Participants will take a pill called ASTX727 for 4 or 5 days every month followed by an injection of Nivolumab one week after the first dose of study medication.

Conditions

Interventions

DRUG

INQOVI (decitabine and cedazuridine)

Oral decitabine (ASTX727) will be administered during D1-5 (DL1) or D1-4 (DL1-1).

DRUG

Nivolumab

Nivolumab will be administered on D8 with every 4 week cycle.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Kyunghee Burkitt, DO, PhD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-02-28
Completion
2026-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357858 on ClinicalTrials.gov