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NCT03220009
Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma
Phase 2 trial testing Conventional Surgery in Cervical Carcinoma. Withdrawn.
1 July 2021
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 3 November 2017 |
| Primary completion | 1 July 2021 |
| Estimated completion | 1 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Conventional Surgery
- Ipilimumab — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Nivolumab (nivolumab) — full drug profile →
- Patient Observation
- Radiation Therapy
Conditions studied
- Cervical Carcinoma — all drugs for Cervical Carcinoma →
- Esophageal Carcinoma — all drugs for Esophageal Carcinoma →
- Mucosal Melanoma — all drugs for Mucosal Melanoma →
- Mucosal Melanoma of the Head and Neck — all drugs for Mucosal Melanoma of the Head and Neck →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, any sex, with Cervical Carcinoma or Esophageal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized phase II trial studies how well nivolumab or expectant observation following ipilimumab, nivolumab, and surgery work in treating patients with high-risk mucosal melanoma that is restricted to the site of origin without evidence of spread, has spread to a local and regional area of the body, or has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Sometimes the mucosal melanoma may not need more treatment until it progresses. In this case, observation may be sufficient. It is not known if nivolumab or expectant observation following ipilimumab, nivolumab, and surgery may be better in treating patients with mucosal melanoma.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
T-Cell Density at the Invasive Margin and Immune Phenotypes Predict Outcome in Vulvar Squamous Cell Cancer.
Burandt E, Blessin NC, Rolschewski AC, Lutz F, et al · · 2022 · cited 7× · PMID 36077784 · DOI 10.3390/cancers14174246
Verify or expand the search:
- PubMed search for NCT03220009
- 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)
- Trial protocol + status: ClinicalTrials.gov NCT03220009 (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 (NCI)
- Last refreshed: 3 October 2018
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/NCT03220009.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing