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NCT03590210: NiTraSarc
Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas
Phase 2 trial testing Trabectedin in Metastatic Adult Soft Tissue Sarcoma in 92 participants. Completed in 12 February 2022.
12 February 2022
Quick facts
| Lead sponsor | University Medicine Greifswald |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 92 |
| Start date | 8 June 2018 |
| Primary completion | 12 February 2022 |
| Estimated completion | 12 February 2022 |
| Sites | 9 locations across Germany |
Drugs / interventions tested
- Trabectedin (TRABECTEDIN) — full drug profile →
- Nivolumab (nivolumab) — full drug profile →
Conditions studied
- Metastatic Adult Soft Tissue Sarcoma — all drugs for Metastatic Adult Soft Tissue Sarcoma →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03590210
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Trabectedin
Trials testing the same drug.
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- NCT04794127 — Study on Trabectedin in Combination With Pioglitazone in Patients Myxoid Liposarcomas With Stable Disease After T Alone. · Phase 2 · completed
- NCT04383119 — Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma · Phase 2 · recruiting
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03590210 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 University Medicine Greifswald
- Last refreshed: 8 November 2022
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing