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)
Name: PDR001
Description: PDR001 is a humanized IgG4 antibodyType: DrugPDR001 with Panobinostat
Name: Panobinostat
Description: Panobinostat is a Histone deacetylase inhibitor (HDACi).Type: DrugPDR001 with Panobinostat
Description: The recommended Phase 2 dose will be determined by using a 3 + 3 design with 1 dose escalation and 2 dose deescalation cohorts. Safety assessments will consist of monitoring and recording all adverse events, including serious adverse events, the monitoring of hematology, chemistry, ECG and the regular monitoring of vital signs, thyroid function, pregnancy and physical exam including weight and performance status.
Measure: To assess the safety and tolerability of PDR001 in combination with panobinostat in determining a recommended Phase II dose Time: Initiation of treatment up to 2 yearsDescription: All adverse events (AEs) will be considered in DLT assessment unless the event is clearly unrelated to trial treatment. The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 will be used.
Measure: Incidence of dose limiting toxicities (DLTs) using CTCAE, Version 5.0 Time: Initiation of treatment up to 2 yearsDescription: PFS is defined as the time between the first dose of study therapy and the earliest date of progression or death (participants who have neither progressed nor dies will be censored at the most recent last-known-alive date).
Measure: Progression free survival (PFS) per RECIST 1.1 Time: Initiation of treatment up to 2 yearsDescription: OS is calculated from time when study therapy begins to death from any cause.
Measure: Overall survival (OS) Time: Initiation of treatment up to 2 yearsDescription: OS is defined as the time between the first dose of study therapy and death (participants who have not died will be censored at the most recent last-known-alive date).
Measure: Overall Response Rate (ORR) per RECIST 1.1 Time: Initiation of treatment up to 2 yearsSingle Group Assignment
There is one SNP
- Patients with NSCLC who are known to have targetable genomic alterations (including EGFR exon 19 deletion or L858R substitution, ALK rearrangement, ROS1 fusion, NTRK 13 fusions, BRAF V600 mutation), must have progressed on or could not tolerate FDA approved targeted therapy for the alterations mentioned above, in addition to progressed on PD-1/L1 Checkpoint blockade to be eligible for the study. --- L858R ---