Conditions: Melanoma
Keywords: BRAF mutation positive advanced melanoma Advanced cutaneous melanoma Unknown primary melanoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 385
Healthy volunteers: no

Brief summary:
To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

Detailed description:

Arms:
arm 1: AZD6244 in combination with dacarbazine arm 2: Placebo in combination with dacarbazine

Interventions: intervention 1: AZD6244 intervention 2: Dacarbazine intervention 3: Placebo
Intervention descriptions: intervention 1: oral capsules, 75mg twice daily intervention 2: 1000 mg/m2 iv infusion over at least 60 min. on day 1 of each 21 cycle intervention 3: Placebo

Protocol document: