tremelimumab (n=328) vs. Standard of Care (SoC) (n=327)
randomized controlled trial
tremelimumab
tremelimumab at 15 mg/kg once every 90 days for up to four cycles.
physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine)
either single-agent DTIC (1,000 mg/m2) IV on day 1 of a 21-day cycle or single-agent temozolomide (200 mg/m2) orally on days 1 to 5 of a 28-day cycle, up to 12 cycles. (64.5% dacarbazine and 33.0% temolozomide)
No dose reductions were permitted
mML - L1 - all population
Eligible patients had an Eastern Cooperative Oncology Group performance status of 0 or 1
open label
114 sites in 24 countries
P3/ two sided test procedure with two interim analysis. Repartition alpha with interim analysis (no IC for HR => CALCUL p value)
This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma