Study of Proton SBRT and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT03539198
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Proton Stereotactic Body Radiation Therapy (SBRT) (5 fractions; 3500-4500 cGy) — RADIATION
    Patients will be receiving proton SBRT
  • Proton Stereotactic Body Radiation Therapy (SBRT) (3-5 fractions; various dose and fractionation regimens depending on treatment site). — RADIATION
    Patients will receive proton SBRT.
  • Nivolumab 3 mg/kg IV q2 weeks — DRUG
    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.
  • Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site). — RADIATION
    Patients with further oligoprogression (5 or fewer sites) will be eligible to receive additional SBRT to all sites of oligoprogression.

Study Details

This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.

Key Dates

Start date
Jul 3, 2018
Status verified
Nov 2024
Primary completion
Jan 6, 2020
Completion
Jan 6, 2020

Study Design

Enrollment
19 participants (actual)

Arms

  • Arm: Locoregional
    Patients with recurrent locoregional head and neck cancer
  • Arm: Metastatic
    Patients with recurrent metastatic head and neck cancer

Primary Outcome Measure

Objective response rate (ORR) using iRECIST 1.1 criteria for locoregional arm [ Time Frame: From start date of immunotherapy to disease progression; up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Scottsdale, AZ

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Rochester· Rochester, MN

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