NCT04315155View on ClinicalTrials.gov

Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2020

Primary Completion Date

September 30, 2023

Study Completion Date

September 30, 2025

Conditions
Metastatic Adenocarcinoma
Interventions
DRUG

Belinostat

"Doublet Regimen Dose levels for Part 1:~Belinostat Dose Level 1 (starting dose) 500 mg/m2 Dose Level 2 750 mg/m2 Dose Level 3 1000 mg/m2"

DRUG

nivolumab

Doublet Regimen Dose levels for Part 1 Nivolumab Dose Level 1 (starting dose) 360 mg Dose Level 2 360 mg Dose Level 3 360 mg

DRUG

ipilimumab

Triplet and Doublet Regimen Dose Levels for Phase 2 Ipilimumab Doublet Dose n/a Triplet Dose 1 mg/kg

DRUG

nivolumab

Triplet and Doublet Regimen Dose Levels for Phase 2 Nivolumab Doublet Dose 360 mg IV Triplet Dose 3 mg/kg

DRUG

Belinostat

Triplet and Doublet Regimen Dose Levels for Phase 2 Belinostat Doublet Dose RP2D Triplet Dose RP2D

Sponsors
All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Acrotech Biopharma Inc.

INDUSTRY

lead

University of Utah

OTHER

NCT04315155 - Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation | Biotech Hunter | Biotech Hunter