Melanoma Clinical Trial
Official title:
Dose-seeking and Efficacy Study of the Combination of the BRAF Inhibitor Vemurafenib and High-dose Interferon Alfa-2b for Therapy of Advanced Melanoma
This is a dose-seeking and efficacy study of combined BRAF Inhibitor Vemurafenib and High-dose Interferon alfa-2b for therapy of advanced melanoma.
- Dose-selection and dose-expansion study of combination therapy with high-dose interferon
alfa-2b and vemurafenib.
- Vemurafenib at standard dosing with a 2 week lead-in period to exploit potential
immunomodulatory effects. Concurrent HDI following this (week 2 onwards) at standard
induction (4 weeks) and maintenance (48 weeks) doses.
- Modified Storer's "up and down" dose escalation schema using 3 fixed dose levels for HDI
and a fixed sample size that allows efficient identification of recommended phase II
dose.
- 36-63 patients will be enrolled depending on toxicity parameters. oIn the dose-selection
portion, 3 patients will be enrolled per dose level, starting from the lowest dose
level. Enrollment will occur serially allowing for the observation of toxicity during
the observation period.
oIterative enrollment of up to 3 subjects per cohort will be continued until a total of 30
evaluable subjects have been enrolled.
oThe dose level at which the RLT rate is the closest to 1/3 will be considered as RP2D.
oDuring the dose-expansion portion of the trial, depending on the number of patients treated
at RP2D during the dose-selection portion, additional patients may be enrolled - the accrual
target is 36 patients treated at RP2D.
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