Last reviewed · How we verify
NCT04123925: NICOLE
Preoperative Nivolumab in Patients With Locally Advanced Colon Cancer (T3 or T4): a Window-of-opportunity Study
Completed
Phase 2
Last updated 12 June 2020
What this trial tests
Phase 2 trial testing Nivolumab in Colon Cancer Stage II/III in 22 participants. Completed in 2 September 2019.
Timeline
12 June 2018
Primary endpoint
17 June 2019
17 June 2019
2 September 2019
Quick facts
| Lead sponsor | National Cancer Institute, Naples |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 12 June 2018 |
| Primary completion | 17 June 2019 |
| Estimated completion | 2 September 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Nivolumab (nivolumab) — full drug profile →
Conditions studied
- Colon Cancer Stage II/III — all drugs for Colon Cancer Stage II/III →
Sponsor
National Cancer Institute, Naples
Who can join
18 and older, any sex, with Colon Cancer Stage II/III. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A monocentric window of opportunity study preceded by a safety run-in phase. The study population will include locally advanced colon patients (T3 or T4).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neoadjuvant Immunotherapy for MSI-H/dMMR Locally Advanced Colorectal Cancer: New Strategies and Unveiled Opportunities.
Zhang X, Wu T, Cai X, Dong J, et al · · 2022 · cited 99× · PMID 35371084 · DOI 10.3389/fimmu.2022.795972 -
Neoadjuvant immunotherapy for colorectal cancer: Right regimens, right patients, right directions?
Zhu J, Lian J, Xu B, Pang X, et al · · 2023 · cited 38× · PMID 36949951 · DOI 10.3389/fimmu.2023.1120684 -
PD-1 blockade in neoadjuvant setting of DNA mismatch repair-deficient/microsatellite instability-high colorectal cancer.
Liu DX, Li DD, He W, Ke CF, et al · · 2020 · cited 37× · PMID 32042474 · DOI 10.1080/2162402x.2020.1711650 -
PD‑1/PD‑L1 immune checkpoint inhibitors in neoadjuvant therapy for solid tumors (Review).
Tang Q, Zhao S, Zhou N, He J, et al · · 2023 · cited 19× · PMID 36866750 · DOI 10.3892/ijo.2023.5497 -
Immunotherapy in the neoadjuvant treatment of gastrointestinal tumors: is the time ripe?
Gervaso L, Ciardiello D, Oliveira RA, Borghesani M, et al · · 2024 · cited 12× · PMID 38782539 · DOI 10.1136/jitc-2023-008027 -
Immunotherapy for Early Stage Colorectal Cancer: A Glance into the Future.
Cohen R, Shi Q, André T. · · 2020 · cited 9× · PMID 32708216 · DOI 10.3390/cancers12071990 -
Neoadjuvant envafolimab in a patient with MSI-H/dMMR colon cancer: a case report and literature review.
Chen Z, Zhou J, Chen W, Wu T, et al · · 2024 · cited 2× · PMID 39259508 · DOI 10.1080/1750743x.2024.2350355 -
Immunotherapy Bridge 2020 and Melanoma Bridge 2020: meeting abstracts.
· 2021 · PMID 33757523 · DOI 10.1186/s12967-020-02685-2
Verify or expand the search:
- PubMed search for NCT04123925
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04123925 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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 National Cancer Institute, Naples
- Last refreshed: 12 June 2020
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/NCT04123925.
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