Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants
Public ClinicalTrials.gov record NCT04495010. 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 Phase 2, Randomized Study of Neoadjuvant Nivolumab Plus Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab Plus Ipilimumab Followed by Either Adjuvant Nivolumab or Postsurgical Observation Depending on Pathologic Response Compared With Adjuvant Nivolumab in Treatment-Naive Patients With Resectable Clinically Detectable Stage III Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.
Study identification
- NCT ID
- NCT04495010
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 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
- Mar 31, 2021 (Estimated)
- Primary completion
- Feb 28, 2024 (Estimated)
- Completion
- Oct 23, 2027 (Estimated)
- Last update posted
- Mar 19, 2021
2021 – 2027
United States locations
- U.S. sites
- 23
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution | Gilbert | Arizona | 85234 | — |
| Local Institution | Tucson | Arizona | 85724 | — |
| Local Institution | San Francisco | California | 94158 | — |
| Local Institution | Aurora | Colorado | 80045 | — |
| Local Institution | Tampa | Florida | 33612 | — |
| Local Institution | Atlanta | Georgia | 30322 | — |
| Local Institution | Atlanta | Georgia | 30342 | — |
| Local Institution | Marietta | Georgia | 30060 | — |
| Local Institution | Annapolis | Maryland | 21401 | — |
| Local Institution | Boston | Massachusetts | 02114 | — |
| Local Institution | Boston | Massachusetts | 02215 | — |
| Local Institution | Minneapolis | Minnesota | 55407 | — |
| Local Institution | Minneapolis | Minnesota | 55455 | — |
| Local Institution | Hattiesburg | Mississippi | 39401 | — |
| Local Institution | St Louis | Missouri | 63110 | — |
| Local Institution | Morristown | New Jersey | 07960 | — |
| Local Institution | New Brunswick | New Jersey | 08901 | — |
| Local Institution | Cleveland | Ohio | 44195 | — |
| Local Institution | Portland | Oregon | 97239 | — |
| Local Institution | Houston | Texas | 77030 | — |
| Local Institution | Salt Lake City | Utah | 84112 | — |
| Local Institution | Charlottesville | Virginia | 22908 | — |
| Local Institution | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 95 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04495010, 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 Mar 19, 2021 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04495010 live on ClinicalTrials.gov.