Trial Profile
A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 01 Jul 2022
Price :
$35
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At a glance
- Drugs Dabrafenib (Primary) ; Trametinib (Primary)
- Indications Malignant melanoma
- Focus Registrational; Therapeutic Use
- Acronyms COMBI-d
- Sponsors GlaxoSmithKline; GSK; Novartis Pharma; Novartis Pharma A.G.
- 22 Jun 2022 According to a Food and Drug Administration media release, the Food and Drug Administration granted accelerated approval to dabrafenib in combination with trametinib for the treatment of adult and pediatric patients greater than equal to 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
- 02 Jul 2021 Results (n=1076) of pooled analysis charactering the incidence, patterns and management of pyrexia in patients receiving dabrafenib plus trametinib in clinical trials (NCT01336634, NCT01682083, NCT01584648, NCT01597908) published in the European Journal of Cancer
- 12 Feb 2021 Results of a clinical validation study assessing Circulating tumour DNA in patients with advanced melanoma from trials COMBI-d and COMBI-MB published in the Lancet Oncology