Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03019003
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Oral Decitabine — DRUG
    DNA methyltransferase inhibitor
  • Durvalumab — DRUG
    anti-PD-L1
  • 5' Azacitidine — DRUG
    DNA methyltransferase inhibitor
  • Tremelimumab — DRUG
    anti-CTLA4

Study Details

This is a non-randomized, open-label, Phase Ib study to assess the safety and efficacy of a DNA methyltransferase inhibitor and immune checkpoint inhibitor(s) (durvalumab and/or tremelimumab) combination therapy in the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have progressed during or after treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 monotherapy for recurrent and/or metastatic disease. The clinical trial is studying drugs that can boost the participant's immune system against the cancer cells as a possible treatment for head and neck cancer. The study interventions involved in this study are: * Oral Decitabine (ASTX 727) and 5' Azacytidine * Durvalumab (MEDI4736) and Tremelimumab

Key Dates

Start date
Mar 20, 2017
Status verified
Aug 2025
Primary completion
Sep 24, 2024
Completion
Sep 24, 2024

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Decitabine and Durvalumab
    Oral decitabine (ASTX 727) will be administered alone in Cycle 1 and the combination of oral decitabine and durvalumab therapy will be given in Cycles 2-12.
  • Experimental: 5' Azacitidine 40 mg/m2 on Days 1-5, Durvalumab, and Tremelimumab
    5' Azacitidine will be administered alone in Cycle 1 and the combination of 5' Azacitidine, durvalumab, and tremelimumab therapy will be given in Cycles 2-12.
  • Experimental: 5' Azacitidine 40 mg/m2 on Days 1-5 and 8-12, Durvalumab, and Tremelimumab
    5' Azacitidine will be administered alone in Cycle 1 and the combination of 5' Azacitidine, durvalumab, and tremelimumab therapy will be given in Cycles 2-12.

Primary Outcome Measure

Change in Immune-based Biomarker Expression at Baseline and 2 Months [ Time Frame: 2 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Massachusetts General Hospital· Boston, MA

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