Clinical Trials /

Study of AMG 330 in Combination With Pembrolizumab in Adult With Relapsed or Refractory Acute Myeloid Leukemia

NCT04478695

Description:

The primary objective of this study is to evaluate the safety and tolerability of AMG 330, administered in combination with pembrolizumab, in participants with relapsed or refractory acute myeloid leukemia (R/R AML).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of AMG 330 in Combination With Pembrolizumab in Adult With Relapsed or Refractory Acute Myeloid Leukemia
  • Official Title: A Phase 1b Study Assessing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 330 cIV in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: 20170646
  • SECONDARY ID: KEYNOTE-613
  • NCT ID: NCT04478695

Conditions

  • Relapsed or Refractory Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
AMG 330Cohort 1
PembrolizumabCohort 1

Purpose

The primary objective of this study is to evaluate the safety and tolerability of AMG 330, administered in combination with pembrolizumab, in participants with relapsed or refractory acute myeloid leukemia (R/R AML).

Detailed Description

      This study will assess the safety and tolerability of AMG 330 in combination with
      pembrolizumab and whether pembrolizumab will enhance the anti-AML activity of AMG 330. Both
      cohort 1 and 2 will include AMG 330 and pembrolizumab with the difference being the
      initiation date for pembrolizumab treatment.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1Experimental
  • AMG 330
  • Pembrolizumab
Cohort 2Experimental
  • AMG 330
  • Pembrolizumab

Eligibility Criteria

        Key Inclusion criteria

          -  AML as defined by the WHO Classification persisting or recurring following one or more
             treatment courses. Except APL

          -  Eastern Cooperative Oncology Group (ECOG) ≤1

        Key Exclusion criteria

          -  Active extramedullary AML in the central nervous system.

          -  Known hypersensitivity to immunoglobulins.

          -  Non-manageable graft versus host disease.
      
Maximum Eligible Age:120 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants who Experience Dose-Limiting Toxicities (DLTs)
Time Frame:Up to 1 year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of Participants who Experience a Response to Treatment
Time Frame:Up to 1 year
Safety Issue:
Description:
Measure:Duration of Response
Time Frame:Up to 1 year
Safety Issue:
Description:
Measure:Serum Concentration of AMG 330
Time Frame:Up to 1 year
Safety Issue:
Description:
Measure:Number of Participants with Anti-AMG 330 Antibody Formation
Time Frame:Up to 1 year
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amgen

Last Updated

October 8, 2020