An observational study in Head and Neck Cancer, sponsored by Mayo Clinic. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Mayo Clinic · Observational
This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's enrollment of 19 is below the median of 100 across 453 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients with locoregional or metastatic head and neck cancers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
One lesion must be safely amenable to irradiation with stereotactic body radiation therapy per the treating radiation oncologist. Prior radiation to this lesion is allowed if given ≥ 6 months prior. One lesion must be measurable by CT or MRI per iRECIST 1.1 criteria and should be separate from the lesion to be irradiated. If this target lesion has been previously irradiated, there must be documented disease progression after radiation per RECIST 1.1.
Adequate bone marrow, hepatic, and renal function based on screening lab values within 35 days prior to beginning immunotherapy:
Exclusion Criteria:
Patients with recurrent locoregional head and neck cancer
Radiation: Proton Stereotactic Body Radiation Therapy (SBRT) (5 fractions; 3500-4500 cGy) · Drug: Nivolumab 3 mg/kg IV q2 weeks · Radiation: Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site).
Patients with recurrent metastatic head and neck cancer
Radiation: Proton Stereotactic Body Radiation Therapy (SBRT) (3-5 fractions; various dose and fractionation regimens depending on treatment site). · Drug: Nivolumab 3 mg/kg IV q2 weeks · Radiation: Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site).
Patients will be receiving proton SBRT
Patients will receive proton SBRT.
Drug page: Nivolumab
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.
Patients with further oligoprogression (5 or fewer sites) will be eligible to receive additional SBRT to all sites of oligoprogression.
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
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
Plan to share: No
Ran from Jul 2018 to primary completion in Jan 2020, 18 months.
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This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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