Radiotherapy + Durvalumab for Squamous Cell Carcinoma

Palo Alto (17 mi)

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.

My cancer is in the oral cavity, larynx, hypopharynx, or oropharynx and is stage II-IVB.

I am willing and able to follow the study's treatment plan and attend all visits.

My cancer can be measured and is larger than 10 mm.

My body weight is over 30kg.

I am fully active and can carry on all pre-disease activities without restriction.

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.

I have not taken any drugs targeting immune checkpoints.

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 do not have any unmanaged ongoing illnesses.

My cancer is p16-positive or in the throat, sinus, neck with unknown origin, or has spread from the start.

I have or had an autoimmune or inflammatory disorder.

I have or had lung inflammation that needed steroids.

I have had an organ or bone marrow transplant from a donor.

Treatment Details

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: