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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
ECOG performance status ≤ 1
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

Study 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.Check my eligibility
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.See study design
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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I am fully active and can carry on all pre-disease activities without restriction.
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I am considered a good candidate for surgery by my ENT surgeon and I am willing to undergo surgery.
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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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My body weight is over 30kg.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose and Dose Limiting Toxicities
Secondary outcome measures
Clinical Response
Evaluate Biomarkers: Gene Expression
Evaluate Biomarkers: Immune Cell Infiltration
+4 more

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
Durvalumab
2017
Completed Phase 2
~3870
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~740
Standard of Care Therapy
2007
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,726 Previous Clinical Trials
2,141,655 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,238 Previous Clinical Trials
288,471,400 Total Patients Enrolled
Sana Karam, MD, PhDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Durvalumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03635164 — Phase 1

Frequently Asked Questions

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

How many people are enrolled in this experiment?

"Unfortunately, this clinical trial has temporarily ceased recruiting. Originally posted on November 1st 2018 and last updated May 12th 2022, it is presently not accepting candidates. However, there are 2675 cancer trials involving squamous cells actively seeking participants along with 333 studies for Durvalumab that need volunteers."

Answered by AI

What earlier experiments have been done with Durvalumab in a clinical setting?

"Currently, 333 clinical trials are underway studying the effects of durvalumab with 52 being in Phase 3. Though primarily based in Cordoba, Texas, this research is taking place at 12952 different sites worldwide."

Answered by AI

Are there still opportunities for participation in this trial?

"This trial, which was initially posted on November 1st 2018 and last updated in May 12th 2022, is no longer recruiting patients. Nevertheless, other clinical trials are actively seeking participants; according to the records provided by clinicaltrials.gov there are 3008 such projects available at this time."

Answered by AI

Are there any adverse effects associated with the use of Durvalumab?

"The safety profile of Durvalumab was assessed to be a 1 as this is an early Phase 1 trial, which has limited clinical data on its effectiveness and potential risks."

Answered by AI

What ailments has Durvalumab been prescribed to treat?

"Durvalumab is routinely utilized to manage advanced, inoperable stage iii non-small cell lung cancer. Additionally, this medication can be prescribed for the treatment of metastatic urothelial carcinoma and other serious medical conditions."

Answered by AI
~3 spots leftby Mar 2025