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Table 2 Schedule of assessments and procedures

From: Vemurafenib plus cobimetinib in unresectable stage IIIc or stage IV melanoma: response monitoring and resistance prediction with positron emission tomography and tumor characteristics (REPOSIT): study protocol of a phase II, open-label, multicenter study

Period Screening Baseline study procedures   Vemurafenib/ Cobimetinib Treatment Period Follow-up after treatment
Cycle Within 28 days before start therapy Within 14 days before start therapy Cycle1 Cycle2 Cycle3 Cycle4 Cycle5 Cycle6 Cycle7+ At progression (EoS) Every 12 weeks
Day 1 14 15 1 21 1 (± 3) 1 (± 3) 1 (± 3) 1 (± 3) 1 (± 3) Within 7 days (on therapy)
In- and exclusion criteria X              
Medical history and demographics X              
Interval medical history   X    X X X X X X X X X X
Physical examination X X    X X X X X X X X X X
Vital signs (Temp, HR, RR)   X    X   X X X X X X X  
Pregnancy test (if indicated) X              
Dermatologic examination X      X     X   X   X
Ophthalmologic examination if indicated              
MUGA scan X      X     X   X X  
12-lead electrocardiography (ECG) X X    X X X X   X   X   
Contrast Enhanced CT (CECT) X X    X   X   X   X X X  
ECOG performance status X X    X X X X X X X X X X
Blood samples X X    X X X X X X X X X  
Informed consent X              
PK blood sample   X    X         X  
DNA blood sample (Substudy 1 and 2)   X            X  
18F-FLT PET (Substudy 1)   X   X          X  
18F-FDG PET   X    X   X       X  
Tumor biopsy (Substudy 1 and 2)   X    X         X  
Adverse events   X    X X X X X X X X X X
Start vemurafenib cobimetinib    X            
  1. X = Assessment/procedure performed to meet the objectives of the study, X = Assessment/procedure performed to monitor vemurafenib/cobimetinib treatment