SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03982134

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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)

NCT03982134 Melanoma Non Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung Melanoma
HPO:Cutaneous melanoma Melanoma Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: PDR001

Description: PDR001 is a humanized IgG4 antibody
Type: Drug
Group Labels: 1

PDR001 with Panobinostat

Name: Panobinostat

Description: Panobinostat is a Histone deacetylase inhibitor (HDACi).
Type: Drug
Group Labels: 1

PDR001 with Panobinostat


Primary Outcomes

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 years

Secondary Outcomes

Description: 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 years

Description: 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 years

Description: 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 years

Description: 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 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

- 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 ---



HPO Nodes


HPO: