A Phase IB/II Study With Azacitidine, Durvalumab, and Tremelimumab in Recurrent and/or Metastatic Head and Neck Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03019003|
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : January 3, 2018
This is a non-randomized, open-label, Phase Ib/II study to assess the safety and efficacy of azacitidine, durvalumab (MEDI4736), and 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:
- Azacitidine (Vidaza)
- Durvalumab (MEDI4736)
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Azacitidine Drug: Durvalumab Drug: Tremelimumab||Phase 1 Phase 2|
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 any disease.
The FDA (the U.S. Food and Drug Administration) has not approved azacitidine 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 three 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 azacitidine may increase the chance of the immune system to recognize the cancer cells. Azacitidine has been tested in other research studies for similar reasons.
In this research study, the investigators are looking for the highest effective dose of azacitidine in combination with durvalumab (MEDI4736) and tremelimumab to improve the natural ability of the immune system to recognize and target head and neck cancer cells.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 20, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2024|
Experimental: Azacitidine, Durvalumab, and Tremelimumab
Azacitidine will be administered alone in Cycle 1 and the combination of azacitidine, durvalumab, and tremelimumab therapy will be given in Cycles 2-5. Azacitidine and durvalumab will be given in Cycles 6-12.
Other Name: VidazaDrug: Durvalumab
Other Name: MEDI4736Drug: Tremelimumab
- Phase I: Biologically Effective Dose (BED) of azacitidine [ Time Frame: 2 months ]Changes in HLA Class I and tumor antigen expression
- Phase II: Progression free survival (PFS) [ Time Frame: 2 years ]RECIST 1.1
- Phase I: Number of participants with treatment-related adverse events [ Time Frame: 2 years ]CTCAE v4.3.
- Phase II: Best overall objective response rate (ORR) [ Time Frame: 2 years ]RECIST 1.1.
- Phase II: Overall survival (OS) [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019003
|Contact: Sara Pai, MD, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Sara Pai, MD, PhD 617-726-5251 email@example.com|
|Principal Investigator: Sara Pai, MD, PhD|
|Principal Investigator: Lori Wirth, MD|
|Principal Investigator:||Sara Pai, MD, PhD||Massachusetts General Hospital|