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

NCT03019003 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-09-16

Study results available
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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

Conditions

Interventions

DRUG

Oral Decitabine

DNA methyltransferase inhibitor

DRUG

Durvalumab

anti-PD-L1

DRUG

5' Azacitidine

DNA methyltransferase inhibitor

DRUG

Tremelimumab

anti-CTLA4

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Astex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Sara Pai, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2024-09-24
Completion
2024-09-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03019003 on ClinicalTrials.gov