OncoMatch/Clinical Trials/NCT06295159
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
Is NCT06295159 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Nivolumab + Relatlimab for melanoma stage iii.
Treatment: Nivolumab · Nivolumab + Relatlimab · Ipilimumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage TX (AJCC 8th edition TNM)
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)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy for melanoma
Exception: Part 1 and Part 2 Cohort A: no prior systemic therapy for melanoma; Part 2 Cohort B: must be refractory to systemic adjuvant therapy (anti-PD1-based or BRAF-MEK inhibitors)
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 refractory to systemic adjuvant therapy (anti-PD1-based or BRAF-MEK inhibitors) (N=40). This excludes patients who previously received adjuvant or neoadjuvant anti-PD1 plus anti-LAG3 or anti-PD1 plus anti-CTLA4.
Cannot have received: anti-PD1 plus anti-LAG3 or anti-PD1 plus anti-CTLA4
This excludes patients who previously received adjuvant or neoadjuvant anti-PD1 plus anti-LAG3 or anti-PD1 plus anti-CTLA4.
Lab requirements
Blood counts
Adequate organ function within 28 days of Cycle 1 Day 1 (C1D1)
Kidney function
Adequate organ function within 28 days of Cycle 1 Day 1 (C1D1)
Liver function
Adequate organ function within 28 days of Cycle 1 Day 1 (C1D1)
Cardiac function
LVEF < 50% by TTE or MUGA within 6 months prior to start of study treatment excluded; Troponin T (TnT) or I (TnI) > 2× institutional ULN excluded
Adequate organ function within 28 days of Cycle 1 Day 1 (C1D1); LVEF < 50% by TTE or MUGA within 6 months prior to start of study treatment excluded; Troponin T (TnT) or I (TnI) > 2× institutional ULN excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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