Phase 2 Study testing the COmbination of Vemurafenib With Cobimetinib in BRAF V600 mutated Melanoma Patients to Normalize LDH and Optimize immunotherapY with Nivolumab and Ipilimumab (COWBOY)
- Conditions
- Stage IV or unresectable stage III, BRAFV600E/K mutation positive melanoma, naïve for BRAF/MEK, PD-1/PD-L1 or CTLA-4 targeting therapyTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003279-23-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
In order to participate in this study, a subject must meet all of the following criteria:
•Adults 18 years and older
•World Health Organization (WHO) Performance Status 0-2
•Histologically or cytologically confirmed Stage IV, or unresectable stage III, BRAF V600E/K mutated melanoma
•Measurable disease according to RECIST 1.1
•Signed and dated informed consent form
•No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1
•No prior BRAFi and/ or MEKi therapy
•No immunosuppressive medications
•Screening laboratory values must meet the following criteria and should be obtained within 10 days prior to randomization:
oWBC = 2.0x109/L, Neutrophils = 1.0x109/L, Platelets = 100 x109/L, Hemoglobin = 5.0mmol/L
oCreatinine = 2x ULN
oAST, ALT = 2.5 x ULN (=5 x ULN for patients with liver metastases)
oBilirubin =2 X ULN
oLDH > ULN, < 3xULN
•No symptomatic brain metastases (asysmptomatic brain metastases, accidentally found during screening can be included)
•No leptomeningeal metastases
•No active autoimmune disease requiring systemic treatment in the past 3 months or a documented history of autoimmune disease, or history of syndrome that required systemic steroids, at daily dose of =10mg prednisone or equivalent, or immunosuppressive medications. (Subjects with vitiligo or resolved childhood asthma/atopy are excluded from this rule (and will not be excluded from this study). Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study.)
•No evidence of interstitial lung disease or active, non-infectious pneumonitis
•No active infection requiring therapy
•No known additional malignancy that is progressing or requires active treatment
•Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days + the time required for nivolumab to undergo five half-lives) after the last dose of study medication
•WOBCP must have a negative serum or urine pregnancy test within 96 hours prior to the start of study treatment and must not be breast feeding
•Men must agree to the use of male contraception during the study treatment period and for at least 31 weeks after the last dose of study drug.
•Currently not participating in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
•No underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Not applicable
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method