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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04478695
Recruitment Status : Terminated (Business Decision)
First Posted : July 21, 2020
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Amgen

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Acute Myeloid Leukemia Drug: AMG 330 Drug: Pembrolizumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 29, 2020
Actual Primary Completion Date : October 17, 2020
Actual Study Completion Date : October 17, 2020


Arm Intervention/treatment
Experimental: Cohort 1 Drug: AMG 330
Continuous intravenous (IV) infusion.

Drug: Pembrolizumab
Intravenous (IV) infusion.

Experimental: Cohort 2 Drug: AMG 330
Continuous intravenous (IV) infusion.

Drug: Pembrolizumab
Intravenous (IV) infusion.




Primary Outcome Measures :
  1. Number of Participants who Experience Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 1 year ]
  2. Number of Participants who Experience Treatment-Emergent Adverse Events (TEAE) [ Time Frame: Up to 1 year ]
  3. Number of Participants who Experience Treatment-Related Adverse Events (TRAE) [ Time Frame: Up to 1 year ]
  4. Number of Participants who Experience a Clinically Significant Change in Vital Sign Measurements [ Time Frame: Up to 1 year ]
  5. Number of Participants who Experience a Clinically Significant Change in Electrocardiograms (ECGs) Results [ Time Frame: Up to 1 year ]
  6. Number of Participants who Experience a Clinically Significant Change in Clinical Laboratory Tests [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. Number of Participants who Experience a Response to Treatment [ Time Frame: Up to 1 year ]
  2. Duration of Response [ Time Frame: Up to 1 year ]
  3. Serum Concentration of AMG 330 [ Time Frame: Up to 1 year ]
  4. Number of Participants with Anti-AMG 330 Antibody Formation [ Time Frame: Up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04478695


Locations
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United States, California
Research Site
Duarte, California, United States, 91010
United States, Texas
Research Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Amgen
Merck Sharp & Dohme Corp.
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04478695    
Other Study ID Numbers: 20170646
KEYNOTE-613 ( Other Identifier: Merck Sharp & Dohme Corp. )
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents