Radiotherapy + Durvalumab for Squamous Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Sana Karam, MD, PhD | Profiles | School ...

Overseen bySana D. Karam

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

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).

+11 more

Exclusion Criteria

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.

History of active primary immunodeficiency

+18 more

Participant Groups

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.

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.

Durvalumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Imfinzi for: