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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT06357858
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INQOVI (decitabine and cedazuridine) — DRUG
    Oral decitabine (ASTX727) will be administered during D1-5 (DL1) or D1-4 (DL1-1).
  • Nivolumab — DRUG
    Nivolumab will be administered on D8 with every 4 week cycle.

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Jul 2024
Primary completion
Feb 28, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Decitabine + Nivolumab
    Oral decitabine (ASTX727) will be administered during D1-5 (DL1) or D1-4 (DL1-1) followed by Nivolumab on D8 with every 4 week cycle. The expected minimum treatment cycle is 2 and maximum treatment cycle of 6. However, treatment can be continued until disease progression.

Primary Outcome Measure

Pharmacodynamics Effect of ASTX727 on global DNA methylation status [ Time Frame: 12 months after completion of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106-

Find similar trials in Cleveland, OH

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

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