Metastatic Renal Cell Carcinoma Clinical Trial
Official title:
Pilot Study of Nivolumab and Procaspase Activating Compound-1 (PAC-1) for
The primary objective of the pilot study is to determine activity of PAC-1 and nivolumab combination in subjects with metastatic renal cell carcinoma previously treated with immune checkpoint inhibitor therapy as assessed by objective response rate (ORR) using RECIST 1.1 criteria.
PAC-1 in combination with nivolumab: The MTD will be determined using a modified-Fibonacci
dose-escalation 3+3 design.
This pilot study will evaluate nivolumab in combination with PAC-1 in subjects with
metastatic RCC. Nivolumab will be delivered by IV infusion on Day 1 and PAC-1 will be taken
orally on Days 1-28 of each 28-day cycle, and response will be evaluated after every 2
cycles. Treatment will continue until disease progression (based on RECIST 1.1 criteria),
unacceptable toxicity, subject refusal, or subject death either from progression of disease,
the therapy itself, or from other causes. Subjects who voluntarily stop the study, have
progressive disease, or unacceptable toxicities will be followed for survival every 3 months
for 12 months from start of study medication
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