Decitabine + Durvalumab for Head and Neck Cancer

Overseen By Sara I Pai, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Massachusetts General Hospital

Must not be taking: Immunosuppressants

Disqualifiers: Autoimmune disease, Organ transplant, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 cycles

13 Participants Needed

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 a man committed to not having children during the trial.

I am fully active or restricted in physically strenuous activity but can do light work.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Oral decitabine is administered alone in Cycle 1, followed by combination therapy with durvalumab in Cycles 2-12

12 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• Durvalumab
• Oral Decitabine (ASTX727)

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 European Union, United States, Japan for the following indications:

Approved in European Union as Imfinzi for:

• Locally advanced, unresectable non-small cell lung cancer (NSCLC)

Approved in United States as Imfinzi for:

• Extensive-stage small cell lung cancer (ES-SCLC)
• Limited-stage small cell lung cancer (LS-SCLC)
• Locally advanced or metastatic urothelial carcinoma

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+

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