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NCT03981146: ANICCA
A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer
Phase 2 trial testing Nivolumab in Colorectal Cancer in 35 participants. Participants enrolled and being followed up; not accepting new ones.
1 October 2024
Quick facts
| Lead sponsor | University of Birmingham |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 28 August 2019 |
| Primary completion | 1 October 2024 |
| Estimated completion | 1 October 2024 |
| Sites | 14 locations across United Kingdom |
Drugs / interventions tested
- Nivolumab (nivolumab) — full drug profile →
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
University of Birmingham
Who can join
18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An open-label, single-arm, phase II, multicentre clinical trial to determine the rate of durable clinical benefit of nivolumab in patients with class II expressing microsatellite stable colorectal cancer.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Efficacy of Immune Checkpoint Inhibitors in Microsatellite Stable Colorectal Cancer: A Systematic Review.
Guven DC, Kavgaci G, Erul E, Syed MP, et al · · 2024 · cited 35× · PMID 38309719 · DOI 10.1093/oncolo/oyae013 -
Redefining the battle against colorectal cancer: a comprehensive review of emerging immunotherapies and their clinical efficacy.
Shebbo S, Binothman N, Darwaish M, Niaz HA, et al · · 2024 · cited 12× · PMID 38533510 · DOI 10.3389/fimmu.2024.1350208 -
Associating resistance to immune checkpoint inhibitors with immunological escape in colorectal cancer.
Ding Y, Wang Z, Zhou F, Chen C, et al · · 2022 · cited 6× · PMID 36248998 · DOI 10.3389/fonc.2022.987302 -
Final results of ANICCA-Class II, a single arm, open-label phase II trial assessing nivolumab in tissue-specific class II expressing metastatic microsatellite stable colorectal cancer, with a parallel assessment of the immunoscore-immune checkpoint as a predictive biomarker for s
Middleton G, Gaskell C, Savage J, Bridgewater J, et al · · 2025 · PMID 41407398 · DOI 10.1136/jitc-2025-012749
Verify or expand the search:
- PubMed search for NCT03981146
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other University of Birmingham trials
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 NCT03981146 (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 University of Birmingham
- Last refreshed: 13 August 2024
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/NCT03981146.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing