Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

• Status: Completed
• Trial end date: 2019-04-25
• Target enrollment: 0
• Participant gender: All

Summary

This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline; Novartis Pharmaceuticals
• Treatments: Dabrafenib; Trametinib; Vemurafenib

Criteria

Key Inclusion Criteria:

• >= 18 years of age

• Stage IIIc or Stage IV BRAF V600E/K cutaneous melanoma

• Measurable disease according to RECIST 1.1

• Women of childbearing potential with negative serum pregnancy test prior to randomisation

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Adequate baseline organ function

Key Exclusion Criteria:

• Any prior use of a BRAF or MEK inhibitor

• Prior systemic anti-cancer treatment in the advanced or metastatic setting; prior systemic treatment in the adjuvant setting is allowed

• History of another malignancy (except subjects who have been disease free for 3 years or with a history of completely resected non-melanoma skin cancer)

• Known HIV, HBV, HCV infection (except chronic or cleared HBV and HCV infection which will be allowed)

• Brain metastases (except if all known lesions were previously treated with surgery or stereotactic radiosurgery and lesions, if still present, are confirmed stable for >= 12 weeks prior to randomisation or if no longer present are confirmed no evidence of disease for >= 12 weeks, and are asymptomatic with no corticosteroid requirements for >= 4 weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= 4 weeks prior to randomisation

• History or evidence of cardiovascular risk (LVEF < LLN; QTcB >= 480 msec; blood pressure or systolic >=140 mmHg or diastolic >= 90 mmHg which cannot be controlled by anti-hypertensive therapy)

• History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)