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Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system. This study is divided into 2 sub-studies/parts designated Part 1 and Part 2 that will enroll in sequence starting with Part 1 followed by Part 2.
Details
| Lead sponsor | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 90 |
| Start date | 2024-05-17 |
| Completion | 2028-11 |
Conditions
- Melanoma Stage III
- Melanoma Stage IV
- Advanced Melanoma
- Melanoma
Interventions
- Nivolumab
- Nivolumab + Relatlimab
- Ipilimumab
Primary outcomes
- Pathologic Major Response (pMR) — Up to 36 Months
The pathologic response rate will be measured by evaluation of the residual viable tumor (RVT). Pathologic Major Response (pMR) is defined as near complete response (pCR) measured as ≤10% RVT + complete response (pCR) measured as 0% RVT.
Countries
United States