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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Decitabine

Phase II: Progression free survival (PFS)

Secondary outcome measures

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

Phase II: Best overall objective response rate (ORR)

Phase II: Overall survival (OS)

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

~3870

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Astex Pharmaceuticals, Inc.Industry Sponsor

95 Previous Clinical Trials

7,948 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,342 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,257 Previous Clinical Trials

288,593,773 Total Patients Enrolled

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03019003 — Phase 1 & 2

Head and Neck Cancers Research Study Groups: Oral Decitabine and Durvalumab

Head and Neck Cancers Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03019003 — Phase 1 & 2

Durvalumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03019003 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please tell me what other research has been conducted on Durvalumab?

"As of now, there are 442 active studies and 67 clinical trials in Phase 3 testing Durvalumab. Most of the trials taking place in Hat Yai, Texas; however, there are a total of 14425 locations running trials for Durvalumab."

Answered by AI

Out of how many people who expressed interest in this trial were accepted?

"Unfortunately, this study is not currently recruiting patients. The clinical trial was first posted on March 20th, 2017 and was last updated on October 30th, 2022. However, if you are looking for other studies, there are currently 499 trials actively enrolling participants with head and neck cancer and 442 studies for Durvalumab actively admitting patients."

Answered by AI

What are the common conditions that doctors attempt to treat with Durvalumab?

"Durvalumab is frequently used to manage refractory anemias. Additionally, this medication can help patients with disease, muscular dystrophy, and advance directives."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients

Sara Pai, MD, PhD 2017. "Oral Decitabine (ASTX727) and Durvalumab in Recurrent and/or Metastatic Head and Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03019003.

All > Head And Neck Cancer