Nivolumab in Eliminating Minimal Residual Disease and Preventing Relapse in Patients With Acute Myeloid Leukemia in Remission After Chemotherapy

Official Title

Randomized Phase II Study to Assess the Role of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Acute Myelogenous Leukemia (AML) Patients After Chemotherapy (Remain Trial)

Summary:

This randomized phase II trial studies how well nivolumab works in eliminating any remaining cancer cells and preventing cancer from returning in patients with acute myeloid leukemia that had a decrease in or disappearance of signs and symptoms of cancer after receiving chemotherapy. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.

Trial Description

Primary Outcome:

  • Progression free survival (PFS)
Secondary Outcome:
  • Incidence of adverse effects of nivolumab assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
  • Non-relapse mortality (NRM)
  • Overall survival (OS)
PRIMARY OBJECTIVES:
  • To evaluate and compare the progression free survival rate after randomization in the two treatment arms (nivolumab versus [vs.] observation).
SECONDARY OBJECTIVES:
  • To determine and compare the overall survival rates in the two arms.
  • To determine and compare the incidence of non-relapse mortality in the two arms.
  • To evaluate the toxicities of nivolumab as maintenance.
TERTIARY OBJECTIVES:
  • To analyze programmed cell death (PD)-ligand (L)1 expression on acute myeloid leukemia (AML) cells from peripheral blood and/or bone marrow samples at diagnosis if available and at the time of study enrollment.
  • To monitor AML minimal residual disease (MRD) by Wilms tumour 1 (WT1) polymerase chain reaction (PCR) at enrollment and at subsequent defined time points in the nivolumab-treated and control groups.
  • To perform an exploratory analysis on the frequencies, absolute numbers and subsets of T cells (including regulatory T cells) in the nivolumab-treated and control groups with an emphasis on activation markers.
  • To perform deep sequencing of T cell receptor (TCR)-alpha and TCR-beta chains on polyclonal T cells at baseline and at subsequent time points in the nivolumab and control groups.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive nivolumab intravenously (IV) over 60 minutes once every 2 weeks. Treatment repeats every 2 weeks for 46 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo standard of care clinical observation for up to 2 years. Upon disease relapse, patients may cross-over to Arm I. After completion of study treatment, patients are followed up for 2 years.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society