The purpose of this study is to determine whether Nivolumab is effective in the treatment of radiation-induced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Sidney Kimmel Cancer Center @ Johns Hopkins
Baltimore, Maryland, United States
Best Objective Response Rate
Number of participants with response. Response will be assessed at baseline (within 4 weeks prior to starting nivolumab) and then every 8 weeks while on Nivolumab, up to 24 weeks. The best objective response will be assessed at 24 weeks. Response will be defined based on RECIST 1.1 criteria where complete response (CR)= disappearance of all target lesions, partial response (PR) is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Time frame: Up to 24 weeks
Percentage of Patients Progression-free at 24 Weeks From the Time of Enrollment
Disease status at 24 weeks will be compared to disease status at the time of enrollment, and response coded based on RECIST 1.1 criteria.
Time frame: 24 weeks
Progression-free Survival
Number of participants alive without progression.
Time frame: Up to 22 months
Duration of Response
The duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, accessed up to 3 years.
Time frame: Up to 22 months
Number of Participants With Treatment-related Adverse Events
Number of participants with treatment-related adverse events as defined by CTCAE 4.0 criteria.
Time frame: up to 100 days post-intervention
Overall Survival
Overall survival was planned to be measured at 5 years post-intervention as the time from enrollment until death. Instead, due to early termination for low accrual, the number of participants alive at the time of study termination is reported.
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Time frame: Up to 22 months