Decitabine and Nivolumab in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Kyunghee Burkitt, DO, PhD
Study ID
NCT07216833
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Decitabine — DRUG
    Participants will receive dose level 1 (DL1). If 2 of 3 participants experience dose limiting toxicity (DLT) on DL1, then the dose will be de-escalated to DL1-1. If 2 of 3 participants experience DLT on DL1-1, then no further de-escalation will occur and no additional participants will be enrolled. DL1: Intravenous (IV) administration of decitabine 20 mg/m2 from Days 1-5 DL1-1: Intravenous (IV) administration of decitabine 20 mg/m2 from Days 1-4
  • Nivolumab — DRUG
    Nivolumab will be used as a fixed dose in combination with de-escalating dose levels (DL1, DL1-1) of decitabine. Participants will receive 480 mg of nivolumab on Day 8 every 4-week cycle.

Study Details

This research study is for people who have recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has been confirmed by tissue or cell analysis and is considered incurable with local treatments. People who are eligible to receive anti-PD-L1 therapy as a first line treatment and whose primary tumor is located in the oral cavity, oropharynx, hypopharynx, or larynx, may be eligible to participate. The purpose of this study is to evaluate the immunogenicity of decitabine in combination with nivolumab, and to evaluate the safety and tolerability of decitabine in combination with nivolumab and to determine the maximum tolerated dose. Decitabine is a drug that is currently approved by the Food and Drug Administration (FDA) for the treatment of myelodysplastic syndrome (MDS). Decitabine is considered an investigational (experimental) drug in this study because it is not approved by the FDA for the treatment of HNSCC. Decitabine is a chemotherapy drug that works by targeting DNA methylation, a process that can restore normal function to genes that are involved in cell growth and differentiation. This can help reduce the growth of cancer cells. Nivolumab is a drug that is approved by the FDA for the treatment of HNSCC, as well as other types of cancer. Nivolumab is an immunotherapy drug that works by helping the body's immune system recognize and attack cancer cells.

Key Dates

Start date
Jan 31, 2026
Status verified
Oct 2025
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Decitabine + Nivolumab
    Participants will receive 28-day cycles of decitabine followed by nivolumab for up to 35 cycles (up to 2 years) or until disease progression or other adverse event(s).

Primary Outcome Measure

Pharmacodynamics data on the effects of decitabine, as measured by change in global DNA methylation status [ Time Frame: Day 1, Day 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer InstituteClevelandOhio44195
Kyunghee Burkitt, DO, PhD, MS
Kyunghee Burkitt, DO, PhD, MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute· Cleveland, OH

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