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PD-L1 Inhibitor
Radiotherapy + Durvalumab for Squamous Cell Carcinoma
Phase 1
Waitlist Available
Led By Sana Karam, MD, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years at time of study entry
Histologically or cytologically confirmed: stage II-IVB oral cavity, stage III-IVB larynx, stage III-IVB hypopharynx, or stage III-IVB HPV and/or p16 negative intermediate-high risk oropharynx head and neck cancer (AJCC 8th edition)
Must not have
History of another primary malignancy except for specified conditions
History of leptomeningeal carcinomatosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study start date to study end date, or death, whichever comes first, up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer treatment and studying its safety. Patients must have a certain type of head and neck cancer that has not spread and must be able to have surgery.
Who is the study for?
Adults over 18 with certain types of head and neck cancer (oral cavity, larynx, hypopharynx, or HPV-negative oropharynx) that can be surgically removed. They should not have had prior treatment with PD1/PD-L1 inhibitors and must be able to follow the study protocol.
What is being tested?
The trial is testing Durvalumab in combination with Stereotactic Body Radiation Therapy before surgery against the standard care for specific head and neck cancers. It's a single-arm phase I/Ib safety trial across multiple centers.
What are the potential side effects?
Durvalumab may cause immune-related side effects such as inflammation in various organs, fatigue, possible infusion reactions like fever or chills, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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My cancer is in the oral cavity, larynx, hypopharynx, or oropharynx and is stage II-IVB.
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My cancer is in the oral cavity, larynx, hypopharynx, or oropharynx and is stage II-IVB.
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I am willing and able to follow the study's treatment plan and attend all visits.
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My cancer can be measured and is larger than 10 mm.
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My body weight is over 30kg.
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I am fully active and can carry on all pre-disease activities without restriction.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had cancer before, but it meets the trial's exceptions.
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I have had cancer spread to the lining of my brain and spinal cord.
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I have not taken any drugs targeting immune checkpoints.
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I am not on any cancer treatments not recommended by NCCN for head and neck cancer.
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I do not have active infections like TB, hepatitis B, C, or HIV.
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I do not have any unmanaged ongoing illnesses.
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My cancer is p16-positive or in the throat, sinus, neck with unknown origin, or has spread from the start.
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I have or had an autoimmune or inflammatory disorder.
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I have or had lung inflammation that needed steroids.
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I have had an organ or bone marrow transplant from a donor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study start date to study end date, or death, whichever comes first, up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study start date to study end date, or death, whichever comes first, up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose and Dose Limiting Toxicities
Secondary study objectives
Clinical Response
Evaluate Biomarkers: Gene Expression
Evaluate Biomarkers: Immune Cell Infiltration
+4 moreAwards & 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: Dose Escalation and ExpansionExperimental Treatment3 Interventions
Part 1 of this trial will use a traditional 3+3 design will be used for this trial (i.e. cohort sizes of 3 patients for the first and second cohort at each dose level). Dose escalation will occur as long as there are minimal dose limiting toxicities.The expectation is that 9 patients will be enrolled to the trial during part 1.This is based on the expectation that all dose levels are safe (i.e. patients will not experience DLTs at all dose levels). The range of patients needed will be 6-12 patients.
Part 2 of this trial will be an expansion cohort. A total of 8 additional patients will be enrolled at the dose level determined to be the MTD in part 1 of the study. These 8 patients will be used to confirm that the MTD is a safe combination, as well as provide additional patients to investigate the efficacy for the treatment combination.
Note: Standard of care surgery will follow 3-6 weeks after medication and radiation treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care Therapy
2007
Completed Phase 2
~10
Durvalumab
2017
Completed Phase 2
~3750
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~950
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,397 Previous Clinical Trials
289,121,635 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,805 Previous Clinical Trials
2,822,325 Total Patients Enrolled
Sana Karam, MD, PhDPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I have had cancer before, but it meets the trial's exceptions.I have had cancer spread to the lining of my brain and spinal cord.You are allergic or hypersensitive to any of the study drugs or their ingredients.I am considered a good candidate for surgery by my ENT surgeon and I am willing to undergo surgery.Your hemoglobin level must be at least 9.0 grams per deciliter (g/dL).My cancer is in the oral cavity, larynx, hypopharynx, or oropharynx and is stage II-IVB.My cancer is in the oral cavity, larynx, hypopharynx, or oropharynx and is stage II-IVB.I have not taken any drugs targeting immune checkpoints.I received my last cancer treatment more than 30 days ago, or more than 6 weeks ago if it was nitrosourea or mitomycin C.I am not on any cancer treatments not recommended by NCCN for head and neck cancer.I do not have active infections like TB, hepatitis B, C, or HIV.I am not pregnant or breastfeeding and willing to use effective birth control.I am post-menopausal or not currently pregnant.I am willing and able to follow the study's treatment plan and attend all visits.You must give permission in writing and sign a form that says it's okay for doctors to perform tests and treatments related to the study.You have participated in another study testing a new medication within the past 3 months.I do not have any unmanaged ongoing illnesses.You are expected to live for at least 24 more weeks.You have a normal level of a certain type of white blood cell called neutrophils.My cancer can be measured and is larger than 10 mm.My body weight is over 30kg.My cancer is p16-positive or in the throat, sinus, neck with unknown origin, or has spread from the start.My organs and bone marrow are functioning well.I have or had an autoimmune or inflammatory disorder.I have not received a live vaccine in the last 30 days.I am fully active and can carry on all pre-disease activities without restriction.I haven't taken strong immune-weakening medicines in the last 14 days, except for common allergy or asthma treatments.I have or had lung inflammation that needed steroids.I have had an organ or bone marrow transplant from a donor.
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