Decitabine + Durvalumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Sara Pai, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a non-randomized, open-label, Phase IbI study to assess the safety and efficacy of oral decitabine (ASTX727) and durvalumab (MEDI4736) 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) * Durvalumab (MEDI4736)

Research Team

Sara Pai, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults with recurrent or metastatic squamous cell carcinoma of the head and neck, who have previously not responded to certain immune therapies. Participants must be in relatively good health with a life expectancy over 6 months, able to provide consent, and willing to use effective birth control methods.

Inclusion Criteria

My head or neck cancer has returned or spread and cannot be cured with treatment.

I am 18 years old or older.

I am a man committed to not having children during the trial.

Exclusion Criteria

I have had cancer spread to the lining of my brain and spinal cord.

I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.

I do not have any unmanaged ongoing illnesses.

Treatment Details

Interventions

• Durvalumab (PD-L1 Inhibitor)
• Oral Decitabine (ASTX727) (DNA Methyltransferase Inhibitor)

Trial Overview The trial is testing oral Decitabine (ASTX727) combined with Durvalumab (MEDI4736) for their effectiveness and safety in treating head and neck cancer that has returned or spread. It's an early-phase study where all participants receive both drugs.

Participant Groups

Group I: Oral Decitabine and Durvalumab Experimental Treatment 2 Interventions

Oral decitabine (ASTX 727) will be administered alone in Cycle 1 and the combination of oral decitabine and durvalumab therapy will be given in Cycles 2-12.

Durvalumab is already approved in Japan for the following indications:

Approved in Japan as Imfinzi for:

• Not specified in provided sources

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Astex Pharmaceuticals, Inc.

Industry Sponsor

Trials

97

Recruited

7,400+

Dr. Harren Jhoti

Astex Pharmaceuticals, Inc.

Chief Executive Officer since 2007

PhD in Biochemistry from Birkbeck College, London

Dr. Harold N. Keer

Astex Pharmaceuticals, Inc.

Chief Medical Officer since 2020

MD

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology