This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.
Study Type
OBSERVATIONAL
Enrollment
19
Patients will be receiving proton SBRT
Patients will receive proton SBRT.
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.
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Objective response rate (ORR) using iRECIST 1.1 criteria for locoregional arm
ORR is defined as the proportion of patients who achieved a best response of complete response (CR) or partial response (PR) using iRECIST 1.1 criteria, and will be evaluated for both the lesion(s) treated with SBRT, referred to as "Target lesion (+SBRT+Nivo), as well as the lesion(s) not treated with SBRT (if applicable), referred to as "Target lesion (+Nivo only)", per the prescribed treatment. The primary endpoint for the locoregional arm will be considered met if the assumption and desired outcome are achieved for ORR in the "Target lesion(s) (+SBRT+Nivo)". Best overall response (BOR) is defined as the best response designation, recorded between the start date of immunotherapy and the date of progression using iRECIST 1.1 criteria.
Time frame: From start date of immunotherapy to disease progression; up to 2 years
Objective response rate (ORR) using iRECIST 1.1 criteria for metastatic arm
ORR is defined as the proportion of patients who achieved a best response of complete response (CR) or partial response (PR) using iRECIST 1.1 criteria, and will be evaluated for both the lesion(s) treated with SBRT, referred to as "Target lesion (+SBRT+Nivo), as well as the lesion(s) not treated with SBRT, referred to as "Target lesion (+Nivo only)", per the prescribed treatment. The primary endpoint for the metastatic arm will be considered met if the assumption and desired outcome are achieved for ORR in the "Target lesion(s) (+Nivo only)" since these are the lesions we hypothesize will have an augmented response from proton SBRT through the abscopal effect. Best overall response (BOR) is defined as the best response designation, recorded between the start date of immunotherapy and the date of progression using iRECIST 1.1 criteria.
Time frame: From start date of immunotherapy to disease progression; up to 2 years
Local control rate for both arms
Time frame: From start date of immunotherapy to disease local progression; up to 1 year
Overall Survival Time for both arms
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Patients with further oligoprogression (5 or fewer sites) will be eligible to receive additional SBRT to all sites of oligoprogression.
Time frame: From start date of immunotherapy to date of death, up to 2 years
Overall Survival for both arms
Time frame: From start date of immunotherapy to 3, 6, 9, and 12 month
Progression-free survival for both arms
Time frame: From start date of immunotherapy to disease progression or death, whichever occurs first; assessed up to 2 years
Time to progression (TTP)
Time frame: From start date of immunotherapy to disease progression, but does not count patients who die from other causes; assessed up to 2 years
New development of distant metastasis for both arms
Time frame: From start date of immunotherapy to disease progression or death, whichever occurs first; assessed up to 2 years
Quality of Life for both arms
Quality of life will be assessed through questionaire EORTC QLQ-H\&N35
Time frame: From start date of immunotherapy (baseline evaluation) to approximately 6 months after enrollment at Day 45, 90, 130, and 170
Quality of Life for both arms
Quality of life will be assessed through questionaire Mayo PRO for Head and Neck
Time frame: From start date of immunotherapy (baseline evaluation) to approximately 6 months after enrollment at Day 45, 90, 130, and 170
Adverse Effects for both arms
Time frame: From start date of immunotherapy (baseline evaluation) to approximately 6 months after enrollment at Day 45, 90, 130 and 170
Predictive and prognostic biomarkers for both arms
a maximum of 5 blood draws will be used
Time frame: Baseline, Day 15-30, 45, 90 and 130