CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Anti-OX40 Agonist Monoclonal Antibody PF-04518600 +7 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03390296
NCT03390296Phase 2Completed

An Open-Label Phase Ib/II Multi-Arm Study of OX40 Agonist Monoclonal Antibody (mAb), Anti-PDL1 mAb, Smoothened Inhibitor, Anti-CD33 mAb, Bcl-2 Inhibitor and Azacitidine as Single-Agents and/or Combinations for the Treatment of Patients With Acute Myeloid Leukemia (AML)

M.D. Anderson Cancer Center·interventional·Posted Jan 4, 2018·Updated Sep 5, 2023

In Brief

A Phase 2 clinical trial evaluating Anti-OX40 Agonist Monoclonal Antibody PF-04518600, Avelumab, and 5 other interventions for Recurrent Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This phase Ib/II trial studies the side effects and best dose of anti-OX40 antibody PF-04518600 (OX40) and how well it works alone or in combination with venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine in treating patients with acute myeloid leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as OX40, avelumab, and gemtuzumab ozogamicin, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Glasdegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as venetoclax and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving OX40, venetoclax, avelumab, glasdegib, gemtuzumab ozogamicin, and azacitidine may work better in treating patients with acute myeloid leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 4, 2018
Enrollment StartDec 27, 2017
Primary CompletionFeb 4, 2022
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 8.5 years ago

Interventions

Anti-OX40 Agonist Monoclonal Antibody PF-04518600biological

Given IV

Avelumabdrug

Given IV

Azacitidinedrug

Given IV or SC

Gemtuzumab Ozogamicindrug

Given IV

Glasdegibdrug

Given PO

Glasdegib Maleatedrug

Given PO

Venetoclaxdrug

Given PO

Azacitidinedrug

Given IV or SC