A Phase 1 interventional study of AMG 330 and Pembrolizumab in Relapsed or Refractory Acute Myeloid Leukemia, sponsored by Amgen. Terminated at 2 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
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).
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 1 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion criteria
Key Exclusion criteria
Drug: AMG 330 · Drug: Pembrolizumab
Drug: AMG 330 · Drug: Pembrolizumab
Continuous intravenous (IV) infusion.
Intravenous (IV) infusion.
Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)
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.
Time frame: 28 days
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
A TEAE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment that occurred after first dose. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests that occurred after first dose were recorded as TEAEs.
Time frame: From first dose of study treatment until 30 days after last dose, or end of study, whichever was earlier; median (min, max) duration was 0.79 (0.79, 0.79) months.
Number of Participants Who Experienced Treatment-related Adverse Events (TRAEs)
A TRAE was defined as any untoward medical occurrence in a clinical study participant considered to have a possible causal relationship with the study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests that were considered to have a possible causal relationship with the study treatment were recorded as TRAEs.
Time frame: From first dose of study treatment until 30 days after last dose, or end of study, whichever was earlier; median (min, max) duration was 0.79 (0.79, 0.79) months.
Complete Remission Without Minimal Residual Disease (CRMRD-)
CRMRD- was measured according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017). CRMRD- was defined as complete remission (CR) with negativity for a genetic marker by quantitative reverse transcription polymerase chain reaction (RT-qPCR), or CR with negativity by multiparametric flow cytometry (MFC). CR was defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) ≥ 1.0 x 109/L (1000/μL); platelet count ≥ 100 x 109/L (100 000/μL).
Time frame: From first dose of study treatment until 30 days after last dose, or end of study, whichever was earlier; median (min, max) duration was 0.79 (0.79, 0.79) months.
Complete Remission (CR)
CR was measured according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017). CR was defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) ≥ 1.0 x 109/L (1000/μL); platelet count ≥ 100 x 109/L (100 000/μL).
Time frame: From first dose of study treatment until 30 days after last dose, or end of study, whichever was earlier; median (min, max) duration was 0.79 (0.79, 0.79) months.
CR With Incomplete Recovery (CRi)
CRi was measured according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017). CRi was defined as all CR criteria (bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) ≥ 1.0 x 109/L (1000/μL); platelet count ≥ 100 x 109/L \[100 000/μL\]), except for residual neutropenia (\< 1.0 x 109/L \[1000/μL\]) or thrombocytopenia (\< 100 x 109/L \[100 000/μL\]).
Time frame: From first dose of study treatment until 30 days after last dose, or end of study, whichever was earlier; median (min, max) duration was 0.79 (0.79, 0.79) months.
Morphological Leukemia-free State (MLFS)
MLFS was measured according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017). MLFS was defined as bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required.
Time frame: From first dose of study treatment until 30 days after last dose, or end of study, whichever was earlier; median (min, max) duration was 0.79 (0.79, 0.79) months.
Partial Remission (PR)
PR was measured according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017). PR was defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25%; and decrease of pre-treatment bone marrow blast percentage by at least 50%.
Time frame: From first dose of study treatment until 30 days after last dose, or end of study, whichever was earlier; median (min, max) duration was 0.79 (0.79, 0.79) months.
Duration of Response (DoR)
DoR was calculated for participants who achieved overall response (CRMRD-, CR, CRi, PR or MLFS). DoR was defined as time from the first observation indicating an objective response to the subsequent date of disease progression or death, whichever is earlier.
Time frame: From first dose of study treatment until 30 days after last dose, or end of study, whichever was earlier; median (min, max) duration was 0.79 (0.79, 0.79) months.
Plasma Concentration of AMG 330
Time frame: Pre-dose, 6hrs post-dose Day 1 to 71 of Cycle 1 (Cycle 1=77 days), pre-dose, 6hrs post-dose Day 1 to 50 of Cycles 2+ (Cycle 2+=57 days); end of infusion,0.5,2,4 and 8hrs post-infusion on Days 78 and 57 of Cycle 1 and 2 infusion-free periods respectively
Half-life of AMG 330
Time frame: Pre-dose, 6hrs post-dose Day 1 to 71 of Cycle 1 (Cycle 1=77 days), pre-dose, 6hrs post-dose Day 1 to 50 of Cycles 2+ (Cycle 2+=57 days); end of infusion,0.5,2,4 and 8hrs post-infusion on Days 78 and 57 of Cycle 1 and 2 infusion-free periods respectively
Steady State Concentration of AMG 330
Time frame: Pre-dose, 6hrs post-dose Day 1 to 71 of Cycle 1 (Cycle 1=77 days), pre-dose, 6hrs post-dose Day 1 to 50 of Cycles 2+ (Cycle 2+=57 days); end of infusion,0.5,2,4 and 8hrs post-infusion on Days 78 and 57 of Cycle 1 and 2 infusion-free periods respectively
Volume of Distribution of AMG 330
Time frame: Pre-dose, 6hrs post-dose Day 1 to 71 of Cycle 1 (Cycle 1=77 days), pre-dose, 6hrs post-dose Day 1 to 50 of Cycles 2+ (Cycle 2+=57 days); end of infusion,0.5,2,4 and 8hrs post-infusion on Days 78 and 57 of Cycle 1 and 2 infusion-free periods respectively
Clearance of AMG 330
Time frame: Pre-dose, 6hrs post-dose Day 1 to 71 of Cycle 1 (Cycle 1=77 days), pre-dose, 6hrs post-dose Day 1 to 50 of Cycles 2+ (Cycle 2+=57 days); end of infusion,0.5,2,4 and 8hrs post-infusion on Days 78 and 57 of Cycle 1 and 2 infusion-free periods respectively
Number of Participants With Anti-AMG 330 Antibody Formation
Time frame: From first dose of study treatment until 30 days after last dose, or end of study, whichever was earlier; median (min, max) duration was 0.79 (0.79, 0.79) months.
1 participant was enrolled into this study at 1 center in the United States.
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 1 | 0 |
| Received amg 330 | 1 | 0 |
| Received pembrolizumab | 0 | 0 |
| Received dexamethasone | 1 | 0 |
| Completed | 0 | 0 |
| Not completed | 1 | 0 |
| Withdrew: Death | 1 | 0 |
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.
No measurements were reported for this outcome.
A TEAE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment that occurred after first dose. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests that occurred after first dose were recorded as TEAEs.
No measurements were reported for this outcome.
A TRAE was defined as any untoward medical occurrence in a clinical study participant considered to have a possible causal relationship with the study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests that were considered to have a possible causal relationship with the study treatment were recorded as TRAEs.
No measurements were reported for this outcome.
CRMRD- was measured according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017). CRMRD- was defined as complete remission (CR) with negativity for a genetic marker by quantitative reverse transcription polymerase chain reaction (RT-qPCR), or CR with negativity by multiparametric flow cytometry (MFC). CR was defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) ≥ 1.0 x 109/L (1000/μL); platelet count ≥ 100 x 109/L (100 000/μL).
No measurements were reported for this outcome.
CR was measured according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017). CR was defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) ≥ 1.0 x 109/L (1000/μL); platelet count ≥ 100 x 109/L (100 000/μL).
No measurements were reported for this outcome.
CRi was measured according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017). CRi was defined as all CR criteria (bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) ≥ 1.0 x 109/L (1000/μL); platelet count ≥ 100 x 109/L \[100 000/μL\]), except for residual neutropenia (\< 1.0 x 109/L \[1000/μL\]) or thrombocytopenia (\< 100 x 109/L \[100 000/μL\]).
No measurements were reported for this outcome.
MLFS was measured according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017). MLFS was defined as bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required.
No measurements were reported for this outcome.
PR was measured according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017). PR was defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25%; and decrease of pre-treatment bone marrow blast percentage by at least 50%.
No measurements were reported for this outcome.
DoR was calculated for participants who achieved overall response (CRMRD-, CR, CRi, PR or MLFS). DoR was defined as time from the first observation indicating an objective response to the subsequent date of disease progression or death, whichever is earlier.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Mortality reporting was from enrollment until end of study; median (min, max) duration was 0.82 (0.82, 0.82) months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 1/1 (100%) | — | — |
The study was terminated with only 1 participant enrolled into Cohort 1 (0 participants were enrolled into Cohort 2). No data are reported here to maintain participant confidentiality.
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Total |
|---|
| Sex: Female, Male(participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Ethnicity (NIH/OMB)(participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Hispanic or Latino | — | — | — |
| Not Hispanic or Latino | — | — | — |
| Unknown or Not Reported | — | — | — |
| Race (NIH/OMB)(participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | — | — | — |
| Asian | — | — | — |
| Native Hawaiian or Other Pacific Islander | — | — | — |
| Black or African American | — | — | — |
| White | — | — | — |
| More than one race | — | — | — |
| Unknown or Not Reported | — | — | — |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amgen