Locally advanced unresectable or metastatic melanoma with BRAFV600 mutation and previously untreated
Conditions
Interventions
Encorafenib: [W00090 GE 2 01 Study] Encorafenib 300 mg (4 x 75 mg) QD, orally. [C4221004 Study] Encorafenib 300 mg or 450 mg QD, orally.
Binimetinib: [W00090 GE 2 01 Study] Binimetinib 45 mg (3 x 15
Sponsors
Oki Kosuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade 3 or more or intolerable Grade 2 AEs considered to be related to study treatment. 2. Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol. 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol. 4. Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
Exclusion criteria: 1. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. AEs leading to permanent discontinuation of study intervention 2. All SAEs | — |
Countries
Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Netherland, Portugal, Russia, Slovakia, South Korea, Spain, UK, US
Contacts
Public ContactKosuke Oki
PPD-SNBL K.K.
Outcome results
None listed