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NCT03590210: NiTraSarc

Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas

Completed Phase 2 Last updated 8 November 2022
What this trial tests

Phase 2 trial testing Trabectedin in Metastatic Adult Soft Tissue Sarcoma in 92 participants. Completed in 12 February 2022.

Timeline
8 June 2018
Primary endpoint
12 February 2022
12 February 2022

Quick facts

Lead sponsorUniversity Medicine Greifswald
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment92
Start date8 June 2018
Primary completion12 February 2022
Estimated completion12 February 2022
Sites9 locations across Germany

Drugs / interventions tested

Conditions studied

Sponsor

University Medicine Greifswald

Who can join

18 and older, any sex, with Metastatic Adult Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The "NiTraSarc" trial evaluates the efficacy and feasibility (as determined by the safety and tolerability) of combined treatment with trabectedin and nivolumab in patients with metastatic or inoperable soft tissue sarcomas

Publications & conference data

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

  1. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
    Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
  2. Improving Immunotherapy Efficacy in Soft-Tissue Sarcomas: A Biomarker Driven and Histotype Tailored Review.
    Roulleaux Dugage M, Nassif EF, Italiano A, Bahleda R. · · 2021 · cited 73× · PMID 34925348 · DOI 10.3389/fimmu.2021.775761
  3. Combination Strategies to Augment Immune Check Point Inhibitors Efficacy - Implications for Translational Research.
    Varayathu H, Sarathy V, Thomas BE, Mufti SS, et al · · 2021 · cited 62× · PMID 34123767 · DOI 10.3389/fonc.2021.559161
  4. Myeloid Cells as Clinical Biomarkers for Immune Checkpoint Blockade.
    Peranzoni E, Ingangi V, Masetto E, Pinton L, et al · · 2020 · cited 60× · PMID 32793228 · DOI 10.3389/fimmu.2020.01590
  5. Macrophages as a Therapeutic Target in Metastatic Prostate Cancer: A Way to Overcome Immunotherapy Resistance?
    Martori C, Sanchez-Moral L, Paul T, Pardo JC, et al · · 2022 · cited 43× · PMID 35053602 · DOI 10.3390/cancers14020440
  6. Targeting tumour-reprogrammed myeloid cells: the new battleground in cancer immunotherapy.
    De Sanctis F, Adamo A, Canè S, Ugel S. · · 2023 · cited 39× · PMID 36161514 · DOI 10.1007/s00281-022-00965-1
  7. Soft Tissue Sarcoma: An Insight on Biomarkers at Molecular, Metabolic and Cellular Level.
    Pillozzi S, Bernini A, Palchetti I, Crociani O, et al · · 2021 · cited 29× · PMID 34207243 · DOI 10.3390/cancers13123044
  8. Biomarkers for immune checkpoint inhibition in sarcomas - are we close to clinical implementation?
    Yiong CS, Lin TP, Lim VY, Toh TB, et al · · 2023 · cited 26× · PMID 37612756 · DOI 10.1186/s40364-023-00513-5

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Other trials of Trabectedin

Trials testing the same drug.

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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/NCT03590210.

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