Melanoma Clinical Trial
Official title:
Phase Ib Study to Assess Safety and Tolerability of PDR001 in Combination With Panobinostat in Metastatic Melanoma and Non-small Cell Lung Cancer After Failure of Prior Anti PD1 or PD-L1 Therapy
The purpose of this research study is to find the dose of the study drug PDR001 that, when given in combination with the drug Panobinostat, results in the best outcomes for metastatic melanoma and non-small cell lung cancer (NSCLC)
This is an open label, non-randomized Phase Ib study combining PDR001 with HDAC inhibitor
Panobinostat in patients with metastatic melanoma and NSCLC who have failed prior Anti PD1 or
PD-L1 therapy.
The primary purpose of this study is to find the recommended Phase II dose (RP2D) of
Panobinostat in combination with PDR001. Standard 3+3 design will be used for dose escalation
or de-escalation. Depending upon tolerability and dosing, the total number of participants
may vary from 9-24. Initially patients will start from dose level '0' and there will be 1
dose escalation level '1' and two de-escalation levels ('-1' and '-2'). The maximum number in
each dose level will be 6.
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