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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and study start date to study end date, or death, whichever comes first, up to 24 months for reporting.

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 more

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: 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