Radiotherapy With Durvalumab Prior to Surgical Resection for HPV Negative Squamous Cell Carcinoma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03635164
Phase
PHASE1
Status
Completed

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Patients will receive one dose of neoadjuvant durvalumab 1500 mg approximately 3-6 weeks prior to standard of care surgery. It will be given concurrently with the first dose of radiation (RT). Patients will receive up to six doses of durvalumab and radiation post-operatively.
  • Stereotactic Body Radiation Therapy (SBRT) — RADIATION
    The starting RT dose level will be given as 6 Gy for 2 fractions (12 Gy total) every other day over approximately one week to sites of gross disease only to minimize exposure to normal tissue. If toxicity develops and surgery is delayed by more than 8 weeks (qualifying as a DLT), the radiation dose will be dropped per protocol for the next set of patients. If this dose is tolerated, the dose will be increased to 6 Gy for 3 fractions (18 Gy total) for the next 3 patients.
  • Standard of Care Therapy — PROCEDURE
    Patients will proceed to surgical resection 3-6 weeks after radiation as recommended by the ENT surgeon.

Study Details

This is a multi-center, prospective, single-arm phase I/Ib safety trial. Patients eligible for treatment must be diagnosed with non-metastatic, biopsy-proven stage II-IVB oral cavity, stage III-IVB larynx and hypopharynx, or stage III-IVB HPV/p16 negative intermediate-high risk oropharynx head and neck cancer, and must be eligible and amenable to surgical resection.

Key Dates

Start date
Nov 12, 2018
Status verified
Jun 2025
Primary completion
Nov 9, 2021
Completion
May 2, 2023

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation and Expansion
    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.

Primary Outcome Measure

Maximum Tolerated Dose and Dose Limiting Toxicities [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 24 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045-
Memorial Hospital CentralColorado SpringsColorado80909-
Poudre Valley HospitalFort CollinsColorado80524-

Find similar trials in Aurora, CO

By research site
University of Colorado Hospital· Aurora, COMemorial Hospital Central· Colorado Springs, COPoudre Valley Hospital· Fort Collins, CO

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