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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Relapsed or Refractory Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: AMG 330
* Drug: Pembrolizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br> | Drug: AMG 330<br>* Continuous intravenous (IV) infusion.<br>Drug: Pembrolizumab<br>* Intravenous (IV) infusion.<br>|
| Experimental: Cohort 2<br> | Drug: AMG 330<br>* Continuous intravenous (IV) infusion.<br>Drug: Pembrolizumab<br>* Intravenous (IV) infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Experience Dose-Limiting Toxicities (DLTs) |  | Up to 1 year | 
| Number of Participants who Experience Treatment-Emergent Adverse Events (TEAE) |  | Up to 1 year | 
| Number of Participants who Experience Treatment-Related Adverse Events (TRAE) |  | Up to 1 year | 
| Number of Participants who Experience a Clinically Significant Change in Vital Sign Measurements |  | Up to 1 year | 
| Number of Participants who Experience a Clinically Significant Change in Electrocardiograms (ECGs) Results |  | Up to 1 year | 
| Number of Participants who Experience a Clinically Significant Change in Clinical Laboratory Tests |  | Up to 1 year | 

Secondary Outcome Measures

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