NCT07216833View on ClinicalTrials.gov

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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

July 31, 2027

Study Completion Date

December 31, 2027

Conditions
Head and Neck CancerHead and Neck NeoplasmsHead and Neck Squamous Cell Carcinoma
Interventions
DRUG

Decitabine

"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"

DRUG

Nivolumab

"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."

Trial Locations (1)

44195

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute, Cleveland

All Listed Sponsors
lead

Kyunghee Burkitt, DO, PhD

OTHER