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NCT02452268

A Phase I/Ib Study of NIZ985 in Combination With PDR001 in Adults With Metastatic Cancers

Terminated Phase 1 Last updated 3 March 2023
What this trial tests

Phase 1 trial testing NIZ985 in Metastatic and Advanced Solid Tumors in 83 participants. Terminated before completion.

Timeline
8 May 2017
Primary endpoint
7 March 2022
7 March 2022

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment83
Start date8 May 2017
Primary completion7 March 2022
Estimated completion7 March 2022
Sites7 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Metastatic and Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phase I/Ib multicenter clinical trial. Single agent dose escalation of NIZ985 followed by expansion. Second escalation of NIZ985 in combination with PDR001 followed by expansion

Publications & conference data

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

  1. Exploring the NK cell platform for cancer immunotherapy.
    Myers JA, Miller JS. · · 2021 · cited 977× · PMID 32934330 · DOI 10.1038/s41571-020-0426-7
  2. Cytokines in the Treatment of Cancer.
    Conlon KC, Miljkovic MD, Waldmann TA. · · 2019 · cited 360× · PMID 29889594 · DOI 10.1089/jir.2018.0019
  3. ALT-803, an IL-15 superagonist, in combination with nivolumab in patients with metastatic non-small cell lung cancer: a non-randomised, open-label, phase 1b trial.
    Wrangle JM, Velcheti V, Patel MR, Garrett-Mayer E, et al · · 2018 · cited 352× · PMID 29628312 · DOI 10.1016/s1470-2045(18)30148-7
  4. Harnessing natural killer cells for cancer immunotherapy: dispatching the first responders.
    Maskalenko NA, Zhigarev D, Campbell KS. · · 2022 · cited 174× · PMID 35314852 · DOI 10.1038/s41573-022-00413-7
  5. The potential and promise of IL-15 in immuno-oncogenic therapies.
    Robinson TO, Schluns KS. · · 2017 · cited 155× · PMID 28823521 · DOI 10.1016/j.imlet.2017.08.010
  6. Immunomodulatory Effects of IL-2 and IL-15; Implications for Cancer Immunotherapy.
    Yang Y, Lundqvist A. · · 2020 · cited 149× · PMID 33266177 · DOI 10.3390/cancers12123586
  7. Engineering cytokine therapeutics.
    Deckers J, Anbergen T, Hokke AM, de Dreu A, et al · · 2023 · cited 132× · PMID 37064653 · DOI 10.1038/s44222-023-00030-y
  8. Immunobiology of the IL-15/IL-15Rα complex as an antitumor and antiviral agent.
    Guo Y, Luan L, Patil NK, Sherwood ER. · · 2017 · cited 131× · PMID 28888485 · DOI 10.1016/j.cytogfr.2017.08.002

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