Table 1.
CheckMate 238 cohort | Real-world cohort | |
---|---|---|
Inclusion criteria | ||
Stage III melanoma diagnosis | Stage IIIAa (only T1b/ulceration, N1–2a), stage IIIB (excluding T0), stage IIIC (excluding T0), or stage IIID melanoma based on AJCC-8 | |
Disease resection | Completely resected, histologically confirmed melanoma with no evidence of disease as per protocol |
Initial diagnosis of resectable melanoma SLNB or CLND on or after the initial diagnosis Wide local excision of primary melanoma at the time of or in the 12 weeks prior to SLNB or lymphadenectomy |
Adjuvant nivolumab administrationb |
Nivolumab 3 mg/kg Q2W Complete resection ≤ 12 weeks prior to randomization |
Nivolumab 240 mg Q2W, 480 mg Q4W, or 3 mg/kg Q2W within the 12 weeks following the latest SLNB or lymphadenectomy (on or after December 20, 2017) |
Other |
Aged ≥ 15 years at index datec ECOG PS 0–1 |
Aged ≥ 15 years at index datec ECOG PS 0–1 or missing (assessed closest to and on or prior to index date) |
Exclusion criteria | ||
Diagnosis of ocular/uveal melanoma prior to index date Nonmelanoma malignancies within 3 years prior to index date Autoimmune diseases prior to index date Conditions requiring systemic corticosteroids or other immunosuppressive medications within 14 days prior to index date Prior therapy for melanoma |
aPatients with AJCC-7 stage IIIA melanoma were not included in CheckMate 238; however, patients with T1b/ulceration, N1–2a, which is considered stage IIIA per AJCC-8, were allowed to enroll in the study
bUp to 12 months, per label (OPDIVO [package insert]. Princeton, NJ Bristol Myers Squibb Company; 2023)
cThe index date was defined as the date of randomization to adjuvant nivolumab treatment in the CheckMate 238 cohort and the initiation date of the adjuvant nivolumab treatment in the real-world cohort
AJCC-7 American Joint Committee on Cancer, Cancer Staging Manual, seventh edition, AJCC-8 American Joint Committee on Cancer, Cancer Staging Manual, eighth edition, CLND complete lymph node dissection, ECOG PS Eastern Cooperative Oncology Group performance status, N node, Q2W every 2 weeks, Q4W every 4 weeks, SLNB sentinel lymph node biopsy, T tumor