NIVES study is an ongoing phase II, single arm, multicenter study. In this trial pts received SBRT to one non-brain measurable lesion and concomitant NIVOLUMAB, an anti-programmed cell death (PD-1). Combining SBRT with NIVO may enhance the antitumor immune responses and improve clinical outcomes, how it was demonstrated for other solid tumors with a phenomenon known as the abscopal effect . It was planned to enrolled a total of 68 pts within 12 months. The objective of the current analysis is to describe the first report of safety profile of NIVO in combination with SBRT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Hypofractionated radiation will be administered to a metastatic disease site at a dose and schedule of 30 Gy in 3 consecutive fractions. The day of first administration of Nivolumab will be designated as Time 1. Nivolumab will be given as flat dose of 240 mg in intravenous infusion beginning on day 1 every 14 days for 6 months, than switch to 480 mg q4-weekly in responding (CR, PR, SD) patients until PD or unacceptable toxicity . SRT will be administered between the first and second administration of Nivolumab (7 days after the first infusion of Nivolumab).
Struttura Complessa di OncologiaIRCCS- Istituto in Tecnologie Avanzate e Modelli Assistenziali in Oncologia Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
ORR Objective Response Rate
Objective Response Rate (ORR) , as determined by investigator assessment per RECIST 1.1 Secondary as determined by investigator assessment per RECIST 1.1
Time frame: 36 months from the first administration of nivolumab
PFS Progression Free Survival
the time between the date of registration and the first date of documented progression, based on invesigator assessment (as per RECIST 1.1 criteria), or death due to any cause, whichever occurs first
Time frame: 36 months from the first administration of nivolumab
OS Overall Survival
the time from registration to the date of death from any cause
Time frame: 36 months from the first administration of nivolumab
ORR (Objective Response Rate) of irradiated and non-irradiated metastases and duration of response
determined by investigator assessment per RECIST 1.1
Time frame: 36 months from the first administration of nivolumab
Incidence, nature and severity of Adverse Event (safety and tolerability)
All Adverse Events (AEs) and laboratory abnormalities will be collected and graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 4.03
Time frame: 36 months from the first administration of nivolumab
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