Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. In Part 2, Part 2 Cohort A and Part 2 Cohort B will enroll simultaneously. Inclusion criteria apply to Part 1 and Part 2 unless otherwise specified. * Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures. * 18 years of age or older * Histologic diagnosis of melanoma (cutaneous, acral, mucosal or unknown primary) belonging to the following American Joint Committee on Cancer (AJCC) 8th edition TNM stages (Tx or T1-4) and (N1b, N1c, N2b, N2c, N3b or N3c) and/or (M1a). * Requirements for prior systemic therapy for melanoma are as follows: 1. Sub-study Part 1: No prior systemic therapy for melanoma (N=30). 2. Sub-study Part 2 Cohort A: No prior systemic therapy for melanoma (N=20) 3. Sub-study Part 2 Cohort B: Locoregionally advanced melanoma that is ref