Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma
Public ClinicalTrials.gov record NCT03220009. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase II Trial of Adjuvant Nivolumab or Expectant Observation Following Neoadjuvant Ipilimumab Plus Nivolumab and Surgical Resection of High-Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03220009
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
- Cervical Carcinoma
- Esophageal Carcinoma
- Mucosal Melanoma
- Mucosal Melanoma of the Head and Neck
- Oral Cavity Mucosal Melanoma
- Recurrent Melanoma
- Stage II Vulvar Cancer AJCC v7
- Stage III Vulvar Cancer AJCC v7
- Stage IIIA Vulvar Cancer AJCC v7
- Stage IIIB Vulvar Cancer AJCC v7
- Stage IIIC Vulvar Cancer AJCC v7
- Stage IV Oral Cavity Cancer AJCC v6 and v7
- Stage IV Vulvar Cancer AJCC v7
- Stage IVA Oral Cavity Cancer AJCC v6 and v7
- Stage IVB Oral Cavity Cancer AJCC v6 and v7
- Stage IVC Oral Cavity Cancer AJCC v6 and v7
- Vaginal Carcinoma
Interventions
- Conventional Surgery Procedure
- Ipilimumab Biological
- Laboratory Biomarker Analysis Other
- Nivolumab Biological
- Patient Observation Other
- Radiation Therapy Radiation
Procedure · Biological · Other + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2, 2017
- Primary completion
- Jun 30, 2021
- Completion
- Jun 30, 2021
- Last update posted
- Oct 2, 2018
2017 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alliance for Clinical Trials in Oncology | Boston | Massachusetts | 02115 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03220009, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2018 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03220009 live on ClinicalTrials.gov.