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Association details:
Biomarker:BRAF wild-type
Cancer:Melanoma
Drug:Koselugo (selumetinib) (MEK inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Docetaxel With or Without AZD6244 in Melanoma

Excerpt:
...To assess the efficacy of AZD6244 in combination with docetaxel, compared with docetaxel alone, in first line patients with wild type BRAF advanced malignant melanoma`Progression Free Survival...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Go to data
Title:

A double blind randomised phase 2 trial of docetaxel with or without AZD6244 in wt BRAF advanced melanoma

Excerpt:
...BRAF Mutation Screening• In the opinion of the investigator the patient is likely to fulfil the eligibility criteria of the main studyMain Study• ≥ 16 years of age, written informed consent• Histologically confirmed, wild type BRAF, metastatic melanoma.• Unresectable Stage III or Stage IV metastatic melanoma.• Measurable disease as defined by modified RECIST criteria. ...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

DOC-MEK: a double-blind randomized phase II trial of docetaxel with or without selumetinib in wild-type BRAF advanced melanoma

Excerpt:
In this double-blind multicentre phase II trial patients with wild-type BRAF melanoma were randomized (1:1) to docetaxel with selumetinib or placebo….The PFS hazard ratio (HR) (selumetinib:placebo) was 0.75 [90% confidence interval (CI) 0.50–1.14; P = 0.130], with a median PFS of 4.23 months (90% CI 3.63–6.90) for docetaxel plus selumetinib and 3.93 months (90% CI 2.07–4.16) for docetaxel alone. There was no significant difference in overall survival. The objective response rate was 32% with selumetinib versus 14% with placebo (P = 0.059).
Secondary therapy:
docetaxel
DOI:
https://doi.org/10.1093/annonc/mdu054