Terminated/Withdrawn
Sponsor ID
20170646
Study of AMG 330 in Combination With Pembrolizumab in Adult with Relapsed or Refractory Acute Myeloid Leukemia
Study Details
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).
Protocol Summary
Primary Outcome Measures
Number of Participants who Experience Dose-Limiting Toxicities (DLTs)
Timeframe: Up to 1 year
Number of Participants who Experience Treatment-Emergent Adverse Events (TEAE)
Timeframe: Up to 1 year
Number of Participants who Experience Treatment-Related Adverse Events (TRAE)
Timeframe: Up to 1 year
Number of Participants who Experience a Clinically Significant Change in Vital Sign Measurements
Timeframe: Up to 1 year
Number of Participants who Experience a Clinically Significant Change in Electrocardiograms (ECGs) Results
Timeframe: Up to 1 year
Number of Participants who Experience a Clinically Significant Change in Clinical Laboratory Tests
Timeframe: Up to 1 year
Secondary Outcome Measures
Number of Participants who Experience a Response to Treatment
Timeframe: Up to 1 year
Duration of Response
Timeframe: Up to 1 year
Serum Concentration of AMG 330
Timeframe: Up to 1 year
Number of Participants with Anti-AMG 330 Antibody Formation
Timeframe: Up to 1 year
Locations
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
University of Texas MD Anderson Cancer Center
Houston, TX, United States, 77030
Status
Recruiting