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PD-L1 Inhibitor

Decitabine + Durvalumab for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Led By Sara Pai, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed recurrent or metastatic SCCHN not amenable to therapy with curative intent

Male subjects with a female partner of childbearing potential must commit to true abstinence or use of contraception

Must not have

Uncontrolled intercurrent illness

Uncontrolled systemic fungal, bacterial or viral infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety and efficacy of the combination of oral decitabine and durvalumab in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who have progressed during or after treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 monotherapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune-related reactions affecting different organs, infusion-related reactions, fatigue, blood count changes which could increase infection risk. Specific side effects will vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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My cancer grew or came back after treatment with specific immune drugs.

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I am not pregnant or cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unmanaged ongoing illnesses.

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I do not have any untreated infections.

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I have experienced severe side effects from previous immunotherapy.

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I have or had inflammatory bowel disease.

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

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

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I have had an autoimmune disease in the last 2 years.

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I have seizures that are not controlled by medication.

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I have been diagnosed with tuberculosis in the past.

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I have brain metastases that need treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decitabine

Phase II: Progression free survival (PFS)

Secondary study objectives

Phase I: Number of participants with treatment-related adverse events

Phase II: Best overall objective response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oral Decitabine and DurvalumabExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

0 / 15Eligibility criteria met