Trials / Terminated
TerminatedNCT04478695
Study of AMG 330 in Combination With Pembrolizumab in Adult With Relapsed or Refractory Acute Myeloid Leukemia
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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).
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 330 | Continuous intravenous (IV) infusion. |
| DRUG | Pembrolizumab | Intravenous (IV) infusion. |
Timeline
- Start date
- 2020-09-29
- Primary completion
- 2020-10-23
- Completion
- 2020-10-23
- First posted
- 2020-07-21
- Last updated
- 2024-03-08
- Results posted
- 2024-03-08
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04478695. Inclusion in this directory is not an endorsement.