NCT03982134

PDR001 + Panobinostat for Melanoma and NSCLC

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Muhammad Furqan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Melanoma
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	PDR001	PDR001 is a humanized IgG4 antibody
DRUG	Panobinostat	Panobinostat is a Histone deacetylase inhibitor (HDACi).

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-05-01
• Completion: 2022-05-01
• First posted: 2019-06-11
• Last updated: 2019-10-04

Regulatory

• FDA-regulated drug study