Clinical trial · Interventional
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
NCT04478695CI-TRIAL-00074847terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Amgen Decision
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Acute Myeloid Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 330 | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1
- interventionNames
- Drug: AMG 330
- Drug: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Cohort 2
- interventionNames
- Drug: AMG 330
- Drug: Pembrolizumab
Primary outcomes (3)
- measure
- Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)
- timeFrame
- 28 days
- description
- A DLT was defined as any of the events described below occurring in a participant during the DLT window, unless clearly attributable to causes other than investigational product: Any treatment-related death, Grade 4 neutropenia, Grade 3-4 non hematologic toxicity not clearly resulting from the underlying leukemia, with some exceptions, cytokine release syndrome, and any Grade 5 toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.