At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) not amenable to curative surgery or radiation therapy.
- ✓Tumor progression or recurrence during or after treatment with anti-PD-1, anti-PDL-1, anti-PDL-2, anti-CTLA-4, or other immune checkpoint inhibitor; most recent dose within 3 months prior to study registration.
- ✓ECOG performance status 0 or 1 at enrollment.
- ✓Age ≥18 years.
- ✕Non-squamous cell carcinoma or squamous cell carcinoma from other head and neck primary sites (e.g., paranasal cavity, nasopharynx, salivary gland).
- ✕Receipt of last anti-cancer therapy ≤21 days prior to first dose of study drug.
- ✕History of another primary malignancy unless treated with curative intent with no active disease ≥5 years before first study dose, or adequately treated non-melanoma skin cancer/lentigo maligna/carcinoma in situ.
- ✕Prior Grade ≥3 immune-related adverse event (irAE) during prior immunotherapy, or any unresolved irAE >Grade 1.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IB Rescue Study With Oral Decitabine (AStX727) and Durvalumab (MEDI4736) Combination Therapy in Recurrent and/or Metastatic Head and Neck Cancer Patients Who Have Progressed on Anti-PD-1, Anti-PD-L1, or Anti-CTLA-4 Monotherapy
In Brief
A Phase 1 clinical trial evaluating Oral Decitabine, Durvalumab, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 13 participants across 1 site.
Detailed Summary
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
Study Details
Timeline
Interventions
DNA methyltransferase inhibitor
anti-PD-L1
DNA methyltransferase inhibitor
anti-CTLA4