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Treatment Study For Patients With Advanced BRAFV600 Mutant Melanoma

Clinical Trial Title: 
Dabrafenib + trametinib followed by ipilimumab + nivolumab at progression or ipilimumab + nivolumab followed by dabrrafenib + trametinib at progression in patients with advanced BRAFV600 mutant melanoma.
Clinical Trial Protocol ID: 
16062405
Clinical Trial Investigator Name: 
Timothy Kuzel, MD
Clinical Trial Protocol Description: 

To provide combination treatment involving dabrafenib, trametinib, ipilimumab, and nivolumab for patients with advanced BRAFV600 mutant melanoma and to collect additional data on treatment safety.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are at least 18 years of age.
  • Have an ECOG performance status of 0 or 1.
  • Have unresectable stage III or stage IV disease.
  • Have measurable disease; all sites of disease must be evaluated within 4 weeks prior to randomization.
  • Have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive.
  • Have BRAFV600 E or K mutant melanoma (whether cutaneous, acral or mucosal primary).
  • Have BRAFV600E or BRAFV600K mutations.
  • Have had prior systemic therapy in the adjuvant setting; however this adjuvant treatment must not have included a cytotoxic T-lymphocyte-associated protein 4 (CTLA4) or programmed cell death 1 (PD1) pathway blocking antibody or a BRAF/MEK inhibitor.
  • Have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting ≥ 4 weeks prior to entering the study.

You will be excluded from the study if any of the following criteria apply to you:

  • Have uveal melanoma.
  • Have had any prior systemic treatment for advanced (measurable metastatic) disease.
  • Have currently active central nervous system (CNS) metastases; patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery [SRS]) that have been stable on head magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan for at least 4 weeks following treatment and within 4 weeks of randomization could be eligible; patients must not have taken any steroids =< 14 days prior to randomization for the purpose of managing their brain metastases; patients with only whole brain irradiation for treatment of CNS metastases will be ineligible.
  • Have no history of or evidence of cardiovascular risks/disease, history of retinal vein occlusion (RVO), evidence of interstitial lung disease or pneumonitis.
  • Have malabsorption or swallowing difficulty.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Melanoma and Soft Tissue
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka, BS, MT(ASCP), BSN, RN, CCRC