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NCT03792724: INTRUST

Phase I-II Study of Intratumoral Urelumab Combined With Nivolumab in Patients With Solid Tumors

Status unknown Phase 1, PHASE2 Last updated 3 January 2019
What this trial tests

Phase 1, PHASE2 trial testing Urelumab + Nivolumab in Neoplasms in 32 participants. Status unknown.

Timeline
30 January 2019
Primary endpoint
30 January 2023
30 January 2023

Quick facts

Lead sponsorClinica Universidad de Navarra, Universidad de Navarra
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment32
Start date30 January 2019
Primary completion30 January 2023
Estimated completion30 January 2023
Sites2 locations across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Who can join

18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Open label, phase I-II study to evaluate the safety and activity of intratumoral urelumab combined with systemic nivolumab in patients with advanced solid tumors. Serial tumor and blood samples will be obtained during the study to characterize the changes induced by treatment in the tumor microenvironment, as well as predictive biomarkers of response.

Publications & conference data

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

  1. Intratumoural administration and tumour tissue targeting of cancer immunotherapies.
    Melero I, Castanon E, Alvarez M, Champiat S, et al · · 2021 · cited 358× · PMID 34006998 · DOI 10.1038/s41571-021-00507-y
  2. New emerging targets in cancer immunotherapy: CD137/4-1BB costimulatory axis.
    Etxeberria I, Glez-Vaz J, Teijeira Á, Melero I. · · 2020 · cited 110× · PMID 32611557 · DOI 10.1136/esmoopen-2020-000733
  3. Maximizing response to intratumoral immunotherapy in mice by tuning local retention.
    Momin N, Palmeri JR, Lutz EA, Jailkhani N, et al · · 2022 · cited 66× · PMID 35013154 · DOI 10.1038/s41467-021-27390-6
  4. Targeting Cbl-b in cancer immunotherapy.
    Augustin RC, Bao R, Luke JJ. · · 2023 · cited 55× · PMID 36750253 · DOI 10.1136/jitc-2022-006007
  5. Beyond PD-1/PD-L1 Inhibition: What the Future Holds for Breast Cancer Immunotherapy.
    Chrétien S, Zerdes I, Bergh J, Matikas A, et al · · 2019 · cited 47× · PMID 31060337 · DOI 10.3390/cancers11050628
  6. The Landscape of Immunotherapy in Advanced NSCLC: Driving Beyond PD-1/PD-L1 Inhibitors (CTLA-4, LAG3, IDO, OX40, TIGIT, Vaccines).
    De Giglio A, Di Federico A, Nuvola G, Deiana C, et al · · 2021 · cited 46× · PMID 34453261 · DOI 10.1007/s11912-021-01124-9
  7. Alternative Routes of Administration for Therapeutic Antibodies-State of the Art.
    Pitiot A, Heuzé-Vourc'h N, Sécher T. · · 2022 · cited 45× · PMID 36134952 · DOI 10.3390/antib11030056
  8. Trial watch: intratumoral immunotherapy.
    Humeau J, Le Naour J, Galluzzi L, Kroemer G, et al · · 2021 · cited 45× · PMID 34676147 · DOI 10.1080/2162402x.2021.1984677

Verify or expand the search:

Other recruiting trials for Neoplasms

Currently open trials in the same condition.

Other Clinica Universidad de Navarra, Universidad de Navarra trials

Trials by the same sponsor.

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Data sources for this page

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