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

Sponsor
University of Utah
Study ID
NCT04315155
Phase
PHASE1
Status
Withdrawn

Conditions

  • Metastatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belinostat — DRUG
    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
  • nivolumab — DRUG
    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
  • ipilimumab — DRUG
    Triplet and Doublet Regimen Dose Levels for Phase 2 Ipilimumab Doublet Dose n/a Triplet Dose 1 mg/kg
  • nivolumab — DRUG
    Triplet and Doublet Regimen Dose Levels for Phase 2 Nivolumab Doublet Dose 360 mg IV Triplet Dose 3 mg/kg
  • Belinostat — DRUG
    Triplet and Doublet Regimen Dose Levels for Phase 2 Belinostat Doublet Dose RP2D Triplet Dose RP2D

Study Details

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.

Key Dates

Start date
Oct 31, 2020
Status verified
Oct 2020
Primary completion
Sep 30, 2023
Completion
Sep 30, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Double Regimen
    belinostat in combination with nivolumab
  • Experimental: Triplet Regimen
    belinostat in combination with nivolumab and ipilimumab

Primary Outcome Measure

rate of dose limiting toxicities (DLTs) during defined DLT period [ Time Frame: 9-12 months ]

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