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

NCT ID: NCT04478695

Last Updated: 2024-03-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2020-10-23

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.

Conditions

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Relapsed or Refractory Acute Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

AMG 330

Intervention Type DRUG

Continuous intravenous (IV) infusion.

Pembrolizumab

Intervention Type DRUG

Intravenous (IV) infusion.

Cohort 2

Group Type EXPERIMENTAL

AMG 330

Intervention Type DRUG

Continuous intravenous (IV) infusion.

Pembrolizumab

Intervention Type DRUG

Intravenous (IV) infusion.

Interventions

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AMG 330

Continuous intravenous (IV) infusion.

Intervention Type DRUG

Pembrolizumab

Intravenous (IV) infusion.

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

* Active extramedullary AML in the central nervous system.
* Known hypersensitivity to immunoglobulins.
* Non-manageable graft versus host disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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City of Hope National Medical Center

Duarte, California, United States

Site Status

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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KEYNOTE-613

Identifier Type: OTHER

Identifier Source: secondary_id

20170646

Identifier Type: -

Identifier Source: org_study_id

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