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Protocol No. S1320

Principal Investigator Albertini, Mark

Phase II

Age Group Adult

Scope National

Sponsor Type National

Title A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma

Objective The purpose of this study is to compare any good and bad effects of receiving the drugs dabrafenib and trametinib continuously to receiving dabrafenib and trametinib with a break in treatment.

Treatment Dabrafenib and trametinib are similar to vemurafenib and have been tested together and found to be safe and effective for patients with advanced melanoma. The combination has been approved by the FDA for the treatment of advanced melanoma. This study is testing whether receiving dabrafenib and trametinib with a break in treatment could extend the time before your cancer gets worse.

Description All patients on this study will receive a lead-in of continuous treatment for 56 days of dabrafenib (twice daily) and trametinib (once daily). If after receiving this continuous lead-in period of dabrafenib and trametinib your disease has not gotten worse you will be put into one of two treatment groups. A computer will by chance assign you to one of two treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other. Group 1 will receive dabrafenib (twice daily) and trametinib (once daily) for a 56-day cycle. This repeats until your disease gets worse or you come off study for some other reason. Group 2 will receive dabrafenib (twice daily) and trametinib (once daily) with a break in treatment during the 56-day cycle. You will take the drugs for days 1-7, skip days 8-28, and then take the drugs again days 29-56. This 56-day cycle repeats until your disease gets worse or you come off study for some other reason. Both dabrafenib and trametinib are taken by mouth on an empty stomach. The once daily dose of trametinib may be taken at the same time as one of the doses of dabrafenib.

Key Eligibility
  • Patients must have histologically or cytologically confirmed Stage IV or unresectable Stage III BRAFV600E or BRAFV600K mutant melanoma
  • Patients must not have brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction
  • Patients must not have received a prior BRAF or MEK inhibitor
  • Patients must have measurable disease
  • Patients must not have received any anti-cancer drug within 28 days prior to registration, and must not have received any nitrosureas or mitomycin C within 42 days prior to registration
  • Patients must not have received any major surgery or immunotherapy within 28 days prior to registration
  • Patients receiving anticoagulation treatment are allowed to participate with INR established within the therapeutic range
  • Patients must not have a history of pneumonitis or interstitial lung disease
  • Patients with known Hepatitis B or Hepatitis C are not eligible
  • Patients with known HIV may be eligible providing they meet the following additional criteria: CD4 cells ≥ 500/uL, serum HIV viral load of < 25,000 IU/ml, and no current antiretroviral therapy
  • Patients must have Zubrod Performance Status of 0, 1, or 2
  • Patients must not be pregnant or nursing because of the risk of fetal harm

Applicable Disease Sites Melanoma/Skin cancer

Therapies Involved Other

Drugs Involved Mekinist (Trametinib); Tafinlor (dabrafenib); Trametinib; dabrafenib

Status Open

Participating Institutions Johnson Creek, UW Cancer Center; Swedish American Hospital, Rockford ; UW Hospital and Clinics