Title: A Phase IB/II Study With Azacitidine, Durvalumab, and Tremelimumab in Recurrent and/or Metastatic Head and Neck Cancer Patients1
Principal Investigators: Sara Pai, MD, PhD, and Lori Wirth, MD, Massachusetts General Hospital, Boston
Description: For this non-randomized, open label, phase 1b/2 study (ClinicalTrials.gov Identifier: NCT03019003), researchers are evaluating the dose, safety, and efficacy of a combination therapy containing azacitidine, durvalumab (MEDI4736), and tremelimumab for patients with metastatic/recurrent squamous cell carcinoma of the head and neck who progress on anti-PD-1, anti-PD-L1, or anti-CTLA-4 monotherapy.
For the study’s phase 1b part, the primary outcome is the biologically effective dose of azacitidine; the secondary outcome is treatment-related adverse events.
For the phase 2 part, the primary outcome is progression-free survival; the secondary outcomes are best overall response rate and overall survival.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT03019003.
Status: Patient enrollment is not yet open.
This study is sponsored by Massachusetts General Hospital in collaboration with the AstraZeneca. No drug being evaluated in this study is yet approved by the U.S. Food and Drug Administration for the treatment of squamous cell carcinoma of the head and neck.
- Clinicaltrials.gov. A phase IB/II rescue study with azacitidine, durvalumab (MEDI4736), and tremelimumab 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. NCT03019003. https://clinicaltrials.gov/ct2/show/NCT03019003. Accessed March 16, 2017.