PDR001 + Panobinostat for Melanoma and NSCLC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03982134|
Recruitment Status : Withdrawn (Sponsor decision to withdraw)
First Posted : June 11, 2019
Last Update Posted : October 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Non Small Cell Lung Cancer||Drug: PDR001 Drug: Panobinostat||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2022|
Experimental: PDR001 with Panobinostat
All enrolled patients will be treated with a combination of PDR001 at 400mg every 4 weeks and panobinostat. Dose and frequency of Panobinostat will vary depending upon the dose-level cohort of the study participants. Each participant will be assigned to a particular dose-level cohort.
PDR001 is a humanized IgG4 antibody
Other Name: spartalizumab
Panobinostat is a Histone deacetylase inhibitor (HDACi).
Other Name: LBH589 lactate
- To assess the safety and tolerability of PDR001 in combination with panobinostat in determining a recommended Phase II dose [ Time Frame: Initiation of treatment up to 2 years ]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.
- Incidence of dose limiting toxicities (DLTs) using CTCAE, Version 5.0 [ Time Frame: Initiation of treatment up to 2 years ]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.
- Progression free survival (PFS) per RECIST 1.1 [ Time Frame: Initiation of treatment up to 2 years ]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).
- Overall survival (OS) [ Time Frame: Initiation of treatment up to 2 years ]OS is calculated from time when study therapy begins to death from any cause.
- Overall Response Rate (ORR) per RECIST 1.1 [ Time Frame: Initiation of treatment up to 2 years ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982134
|Principal Investigator:||Muhammad Furqan, MD||University of Iowa|