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).
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
Drug | Synonyms | Arms |
---|
AMG 330 | | Cohort 1 |
Pembrolizumab | | Cohort 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
Name | Type | Description | Interventions |
---|
Cohort 1 | Experimental | | |
Cohort 2 | Experimental | | |
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: | Terminated |
Lead Sponsor: | Amgen |
Last Updated
February 21, 2021