Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-31 @ 5:19 AM
Study NCT ID:
NCT03019003
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2017-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
The study interventions involved in this study are:
* Oral Decitabine (ASTX 727) and 5' Azacytidine
* Durvalumab (MEDI4736) and Tremelimumab
Detailed Description:
This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drugs are still being studied.
The FDA (the U.S. Food and Drug Administration) has not approved durvalumab (MEDI4736) or tremelimumab as a treatment for head and neck cancer.
The FDA (the U.S. Food and Drug Administration) has not approved oral decitabine (ASTX 7272) or 5' Azacytidine for the participant's specific disease but it has been approved for other uses.
This is a first in human study evaluating the safety of combining these different drugs. Durvalumab (MEDI4736) and tremelimumab are part of a family of proteins that make up the immune system. The body generates these proteins, or antibodies, in response to foreign substances (particles not typically found in the body such as bacteria and viruses) and these antibodies can protect against infection. Durvalumab (MEDI4736) and tremelimumab are antibodies that are being studied in several other clinical trials to see if it has an effect in helping the immune system to recognize and eliminate abnormal cells in the body.
Investigators hope that DNA methyltransferase inhibitors may increase the chance of the immune system to recognize the cancer cells.
In this research study, the investigators are looking for the highest effective dose of DNA methyltransferase inhibitors in combination with durvalumab (MEDI4736) and/or tremelimumab to improve the natural ability of the immune system to recognize and target head and neck cancer cells.
The FDA (the U.S. Food and Drug Administration) has not approved durvalumab (MEDI4736) or tremelimumab as a treatment for head and neck cancer.
The FDA (the U.S. Food and Drug Administration) has not approved oral decitabine (ASTX 7272) or 5' Azacytidine for the participant's specific disease but it has been approved for other uses.
This is a first in human study evaluating the safety of combining these different drugs. Durvalumab (MEDI4736) and tremelimumab are part of a family of proteins that make up the immune system. The body generates these proteins, or antibodies, in response to foreign substances (particles not typically found in the body such as bacteria and viruses) and these antibodies can protect against infection. Durvalumab (MEDI4736) and tremelimumab are antibodies that are being studied in several other clinical trials to see if it has an effect in helping the immune system to recognize and eliminate abnormal cells in the body.
Investigators hope that DNA methyltransferase inhibitors may increase the chance of the immune system to recognize the cancer cells.
In this research study, the investigators are looking for the highest effective dose of DNA methyltransferase inhibitors in combination with durvalumab (MEDI4736) and/or tremelimumab to improve the natural ability of the immune system to recognize and target head and neck cancer cells.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: