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NCT02117219

Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome

Completed Phase 1 Last updated 10 May 2019
What this trial tests

Phase 1 trial testing MEDI4736 Evaluate MEDI4736 in MDS in Myelodysplastic Syndrome in 67 participants. Completed in 30 April 2019.

Timeline
20 May 2014
Primary endpoint
30 April 2019
30 April 2019

Quick facts

Lead sponsorMedImmune LLC
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment67
Start date20 May 2014
Primary completion30 April 2019
Estimated completion30 April 2019
Sites21 locations across France, United Kingdom, United States, Germany

Drugs / interventions tested

Conditions studied

Sponsor

MedImmune LLC — full company profile →

Who can join

Adults 18 to 99, any sex, with Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents

Publications & conference data

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

  1. Immune checkpoint therapy in liver cancer.
    Xu F, Jin T, Zhu Y, Dai C. · · 2018 · cited 299× · PMID 29843754 · DOI 10.1186/s13046-018-0777-4
  2. Epigenetic regulation in the tumor microenvironment: molecular mechanisms and therapeutic targets.
    Yang J, Xu J, Wang W, Zhang B, et al · · 2023 · cited 251× · PMID 37217462 · DOI 10.1038/s41392-023-01480-x
  3. Combining epigenetic and immune therapy to overcome cancer resistance.
    Gomez S, Tabernacki T, Kobyra J, Roberts P, et al · · 2020 · cited 130× · PMID 31877341 · DOI 10.1016/j.semcancer.2019.12.019
  4. Targeting the Immune Microenvironment in Acute Myeloid Leukemia: A Focus on T Cell Immunity.
    Lamble AJ, Lind EF. · · 2018 · cited 95× · PMID 29951373 · DOI 10.3389/fonc.2018.00213
  5. Checkpoint inhibitors in hematological malignancies.
    Ok CY, Young KH. · · 2017 · cited 93× · PMID 28482851 · DOI 10.1186/s13045-017-0474-3
  6. The emerging role of immune checkpoint based approaches in AML and MDS.
    Boddu P, Kantarjian H, Garcia-Manero G, Allison J, et al · · 2018 · cited 82× · PMID 28679300 · DOI 10.1080/10428194.2017.1344905
  7. Trial Watch: Immunomodulatory monoclonal antibodies for oncological indications.
    Buqué A, Bloy N, Aranda F, Castoldi F, et al · · 2015 · cited 79× · PMID 26137403 · DOI 10.1080/2162402x.2015.1008814
  8. The double-edged sword of (re)expression of genes by hypomethylating agents: from viral mimicry to exploitation as priming agents for targeted immune checkpoint modulation.
    Wolff F, Leisch M, Greil R, Risch A, et al · · 2017 · cited 68× · PMID 28359286 · DOI 10.1186/s12964-017-0168-z

Verify or expand the search:

Other recruiting trials for Myelodysplastic Syndrome

Currently open trials in the same condition.

Other MedImmune LLC trials

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Data sources for this page

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/NCT02117219.

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