NL-OMON48120CompletedPhase 2
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) - COWBOY
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •In order to participate in this study, a subject must meet all of the following
- •* 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:
- •o WBC * 2.0x109/L, Neutrophils * 1.0x109/L, Platelets * 100
- •x109/L, Hemoglobin * 5.0mmol/L
- •o Creatinine * 2x ULN
- •o AST, ALT * 2.5 x ULN (*5 x ULN for patients with liver
- •metastases)
- •o Bilirubin *2 X ULN
- •o LDH > 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
- •* 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
Exclusion Criteria
- •Not applicable
Investigators
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