The STARBOARD Study: Phase 3 Study of Encorafenib and Binimetinib Plus Pembrolizumab in BRAF V600E/K Mutation-Positive Metastatic or Unresectable Locally Advanced Melanoma

Prior treatment

• Previous administration with an investigational drug ≤ 6 months prior to enrollment (SLI)/randomization (Phase 3)
• History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to enrollment (SLI)/randomization (Phase 3).
• Concurrent neuromuscular disorder that is associated with the potential of elevated CK.
• Any active infection requiring systemic therapeutic treatment within 2 weeks prior to enrollment (SLI)/ randomization (Phase 3).
• Prior or current symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases.

Other illness

• Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment in the past 2 years.
• Clinically significant cardiovascular disease.
• Current noninfectious pneumonitis/interstitial lung disease or history of noninfectious pneumonitis/interstitial lung disease requiring steroids, or history of radiation pneumonitis.

Other

• Mucosal or ocular melanoma
• History or current evidence of RVO or current risk factors for RVO.

• Male or female participants ≥18 years of age at the time of informed consent.
• Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition.
• Documented evidence of a BRAF V600E or V600K mutation
• Submission of adequate tumor tissue for central laboratory testing of BRAF V600E/K mutation is required for all participants during the screening period and prior to enrollment (SLI)/randomization (Phase 3).
• SLI Participants: Have not received more than 1 prior systemic therapy for metastatic or locally advanced melanoma.
• Phase 3 Participants: Have not received prior first-line systemic therapy for metastatic or unresectable locally advanced melanoma.
• Have at least 1 measurable lesion per RECIST v1.1.
• ECOG PS of 0 or 1, and adequate organ and cardiac function, including LVEF ≥50% by cardiac imaging.