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

Amgen

Status and phase: Terminated; Phase 1

Conditions: Relapsed or Refractory Acute Myeloid Leukemia

Treatments: Drug: Pembrolizumab; Drug: AMG 330

Study type: Interventional

Funder types: Industry

Identifiers

NCT04478695

20170646

KEYNOTE-613 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Cohort 1

Experimental group

Treatment:

Drug: AMG 330

Drug: Pembrolizumab

Cohort 2

Experimental group

Treatment:

Drug: AMG 330

Drug: Pembrolizumab