Ignite Creation Date:
2024-05-06 @ 2:26 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04315155
Status:
WITHDRAWN
Last Update Posted:
2020-10-28
First Post:
2020-03-17
Brief Title:
Evaluating Safety Efficacy Belinostat Combo w Nivo Alone w Ipi in Patients w Treated MetastaticAdvanced Carcinomas w ARID1A Lof Mutation
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Ph I Study to Evaluate the Safety and Efficacy of Belinostat in Combination With Nivolumab Alone and With Ipilimumab in Patients With Previously Treated Metastatic or Advanced Carcinomas Enriched for ARID1A Loss of Function Lof Mutation
Status:
WITHDRAWN
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study abandoned for funding issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BENEFIT
Brief Summary:
This is an open-label Phase I trial designed to determine the phase 2 recommended dose RP2D of belinostat in combination with nivolumab with or without ipilimumab
Detailed Description:
Overall the trial will assess dosing and safety of two regimens in the study population
The double regimen belinostat in combination with nivolumab
The triplet regimen belinostat in combination with nivolumab and ipilimumab The trial will consist of two parts Part 1 will establish the RP2D of belinostat in combination with nivolumab doublet regimen and Part 2 will assess the safety of the RP2D of belinostat in combination with nivolumab doublet regimen and ipilimumab triplet regimen In Part 1 the recommended phase 2 dose of belinostat will be determined by using an single-patient accelerated titration design confirmed by a modified 33 design
Once the RP2D of belinostat is confirmed in Part 1 Part 2 will open to the expansion of the doublet regimen and begin assessing the triplet regimen The assessment of safety for the triplicate regimen will follow a Bayesian approach as described in the Statistical Analysis section and Appendix 2
Due to the expected contrast in toxicity profiles between immediate toxicity from belinostat at various dose levels and immune mediated toxicity from the doublet and the triplet regimens the definition of dose-limiting toxicities and the DLT evaluation periods will differ for each regimen doublet vs triplicate Patients will be managed according to the regimen administered
Statistical Hypotheses Belinostat in combination with nivolumab alone and with ipilimumab is safe and effective in patients with previously treated metastatic or advanced carcinomas with or without ARID1A loss of function lof mutations
The double regimen belinostat in combination with nivolumab
The triplet regimen belinostat in combination with nivolumab and ipilimumab The trial will consist of two parts Part 1 will establish the RP2D of belinostat in combination with nivolumab doublet regimen and Part 2 will assess the safety of the RP2D of belinostat in combination with nivolumab doublet regimen and ipilimumab triplet regimen In Part 1 the recommended phase 2 dose of belinostat will be determined by using an single-patient accelerated titration design confirmed by a modified 33 design
Once the RP2D of belinostat is confirmed in Part 1 Part 2 will open to the expansion of the doublet regimen and begin assessing the triplet regimen The assessment of safety for the triplicate regimen will follow a Bayesian approach as described in the Statistical Analysis section and Appendix 2
Due to the expected contrast in toxicity profiles between immediate toxicity from belinostat at various dose levels and immune mediated toxicity from the doublet and the triplet regimens the definition of dose-limiting toxicities and the DLT evaluation periods will differ for each regimen doublet vs triplicate Patients will be managed according to the regimen administered
Statistical Hypotheses Belinostat in combination with nivolumab alone and with ipilimumab is safe and effective in patients with previously treated metastatic or advanced carcinomas with or without ARID1A loss of function lof mutations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None