NCT04478695 is a Phase 1 clinical trial of AMG 330 in Relapsed or Refractory Acute Myeloid Leukemia, sponsored by Amgen.

Who is sponsoring NCT04478695?

NCT04478695 is sponsored by Amgen.

What drugs are being tested in NCT04478695?

Interventions in NCT04478695: AMG 330, Pembrolizumab.

What condition does NCT04478695 study?

NCT04478695 studies Relapsed or Refractory Acute Myeloid Leukemia.

Is NCT04478695 still recruiting?

NCT04478695 is currently terminated. Last updated 8 March 2024.

Are results published for NCT04478695?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-08 · How we verify

NCT04478695

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Results posted Last updated 8 March 2024

What this trial tests

Phase 1 trial testing AMG 330 in Relapsed or Refractory Acute Myeloid Leukemia in 1 participant. Terminated before completion.

Timeline

29 September 2020

Primary endpoint
23 October 2020

23 October 2020

Quick facts

Lead sponsor	Amgen
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	29 September 2020
Primary completion	23 October 2020
Estimated completion	23 October 2020
Sites	2 locations across United States

Drugs / interventions tested

AMG 330 — full drug profile →
Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Relapsed or Refractory Acute Myeloid Leukemia — all drugs for Relapsed or Refractory Acute Myeloid Leukemia →

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 120, any sex, with Relapsed or Refractory Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Bispecific Antibodies: From Research to Clinical Application.
Ma J, Mo Y, Tang M, Shen J, et al · · 2021 · cited 199× · PMID 34025638 · DOI 10.3389/fimmu.2021.626616
T-cell-based immunotherapy of acute myeloid leukemia: current concepts and future developments.
Daver N, Alotaibi AS, Bücklein V, Subklewe M. · · 2021 · cited 178× · PMID 33953290 · DOI 10.1038/s41375-021-01253-x
Natural killer cell-based immunotherapy for acute myeloid leukemia.
Xu J, Niu T. · · 2020 · cited 83× · PMID 33287858 · DOI 10.1186/s13045-020-00996-x
Immunotherapy in Acute Myeloid Leukemia: Where We Stand.
Isidori A, Cerchione C, Daver N, DiNardo C, et al · · 2021 · cited 76× · PMID 34041025 · DOI 10.3389/fonc.2021.656218
Bispecific Antibodies: A Smart Arsenal for Cancer Immunotherapies.
You G, Won J, Lee Y, Moon D, et al · · 2021 · cited 39× · PMID 34358141 · DOI 10.3390/vaccines9070724
Recent Advances in Immune-Based Therapies for Acute Myeloid Leukemia.
Restelli C, Ruella M, Paruzzo L, Tarella C, et al · · 2024 · cited 36× · PMID 38904305 · DOI 10.1158/2643-3230.bcd-23-0202
Translating recent advances in the pathogenesis of acute myeloid leukemia to the clinic.
Bewersdorf JP, Abdel-Wahab O. · · 2022 · cited 36× · PMID 35318270 · DOI 10.1101/gad.349368.122
BiTEs, DARTS, BiKEs and TriKEs-Are Antibody Based Therapies Changing the Future Treatment of AML?
Allen C, Zeidan AM, Bewersdorf JP. · · 2021 · cited 35× · PMID 34071099 · DOI 10.3390/life11060465

Verify or expand the search:

Other trials of AMG 330

Trials testing the same drug.

NCT02520427 — A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies · Phase 1 · terminated

Other recruiting trials for Relapsed or Refractory Acute Myeloid Leukemia

Currently open trials in the same condition.

NCT06879847 — A Single-arm, Prospective Study of TBI + BUMEL As a Conditioning Regimen for Salvage HSCT in Patients with R/R AML · NA · recruiting
NCT06812104 — Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
NCT05726110 — Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia · Phase 3 · recruiting

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04478695 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 8 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04478695.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing