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

NCT04315155 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-10-28

No results posted yet for this study

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.

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 & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2023-09-30
Completion
2025-09-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04315155 on ClinicalTrials.gov