NCT03539198 - Study of Proton SBRT and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 3, 2018

Primary Completion Date

January 6, 2020

Study Completion Date

January 6, 2020

Conditions

Head and Neck Cancer

Interventions

RADIATION

Proton Stereotactic Body Radiation Therapy (SBRT) (5 fractions; 3500-4500 cGy)

Patients will be receiving proton SBRT

RADIATION

Proton Stereotactic Body Radiation Therapy (SBRT) (3-5 fractions; various dose and fractionation regimens depending on treatment site).

Patients will receive proton SBRT.

DRUG

Nivolumab 3 mg/kg IV q2 weeks

Patients will receive Nivolumab x2 cycles before SBRT q2 weeks, and continued q2 weeks after SBRT until progression or at the discretion of the treating physician.

RADIATION

Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site).

Patients with further oligoprogression (5 or fewer sites) will be eligible to receive additional SBRT to all sites of oligoprogression.

Trial Locations (2)

55905

Mayo Clinic in Rochester, Rochester

85259

Mayo Clinic in Arizona, Scottsdale