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The STARBOARD Study: Phase 3 Study of Encorafenib and Binimetinib Plus Pembrolizumab in BRAF V600E/K Mutation-Positive Metastatic or Unresectable Locally Advanced Melanoma
EU CTIS ID: 2024-512038-13-00
What this study is testing
Safety Lead-In: To determine the RP3D of encorafenib and binimetinib when given in combination with pembrolizumab. Randomized Phase 3: To compare the efficacy of encorafenib and binimetinib plus pembrolizumab (Triplet Arm) versus placebo plus pembrolizumab (Control Arm) with respect to OR by BICR assessment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female participants ≥18 years of age at the time of informed consent.
- 2. Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition.
- 3. Documented evidence of a BRAF V600E or V600K mutation
- 4. 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).
- 5. SLI Participants: Have not received more than 1 prior systemic therapy for metastatic or locally advanced melanoma.
- 6. Phase 3 Participants: Have not received prior first-line systemic therapy for metastatic or unresectable locally advanced melanoma.
You likely can't join if
- 1. Mucosal or ocular melanoma
- 10. Previous administration with an investigational drug ≤ 6 months prior to enrollment (SLI)/randomization (Phase 3)
- 2. Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment in the past 2 years.
- 3. Clinically significant cardiovascular disease.
- 4. History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to enrollment (SLI)/randomization (Phase 3).
- 5. History or current evidence of RVO or current risk factors for RVO.
See the full eligibility criteria
- 1. Male or female participants ≥18 years of age at the time of informed consent.
- 2. Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition.
- 3. Documented evidence of a BRAF V600E or V600K mutation
- 4. 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).
- 5. SLI Participants: Have not received more than 1 prior systemic therapy for metastatic or locally advanced melanoma.
- 6. Phase 3 Participants: Have not received prior first-line systemic therapy for metastatic or unresectable locally advanced melanoma.
- 7. Have at least 1 measurable lesion per RECIST v1.1.
- 8. ECOG PS of 0 or 1, and adequate organ and cardiac function, including LVEF ≥50% by cardiac imaging.
- 1. Mucosal or ocular melanoma
- 10. Previous administration with an investigational drug ≤ 6 months prior to enrollment (SLI)/randomization (Phase 3)
- 2. Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment in the past 2 years.
- 3. Clinically significant cardiovascular disease.
- 4. History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to enrollment (SLI)/randomization (Phase 3).
- 5. History or current evidence of RVO or current risk factors for RVO.
- 6. Concurrent neuromuscular disorder that is associated with the potential of elevated CK.
- 7. Any active infection requiring systemic therapeutic treatment within 2 weeks prior to enrollment (SLI)/ randomization (Phase 3).
- 8. Current noninfectious pneumonitis/interstitial lung disease or history of noninfectious pneumonitis/interstitial lung disease requiring steroids, or history of radiation pneumonitis.
- 9. Prior or current symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases.
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- Canada
- Argentina
- Ukraine
- Brazil
- Mexico
- New Zealand
- Turkey
- United Kingdom
- Switzerland
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa; Canada; Argentina; Ukraine; Brazil; Mexico and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.