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Phase III, Randomized Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients with Advanced BRAFV600 Mutant Melanoma.

Research & Trial Information

SCHEMA EA6134 1

Protocol#: ECOG – EA6134

Cancer Type: Melanoma

Eligibility Criteria Step 1

  1. Age ≥ 18 years.
  2. ECOG Performance status: 0 or 1.
  3. Women must not be pregnant or breast-feeding.
  4. Patients must have unresectable stage III or stage IV disease.
  5. Patients must have measurable disease as defined in Section 6.1. All sites of disease must be evaluated within 4 weeks prior to randomization.
  6. Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive.NOTE: Any patient with BRAFV600 mutant melanoma (whether cutaneous, acral or mucosal primary) who meets the eligibility criteria is eligible for participation in this trial. Patients with uveal melanoma are not eligibile for this trial.
  7. Patients must have BRAFV600 mutation, identified by an FDA-approved test at a CLIA-certified lab. If test at CLIA-certified lab used a non-FDA approved method, information about the assay must be provided. (FDA approved tests for BRAF V600 mutations in melanoma include: THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test).
  8. Patients may have had prior systemic therapy in the adjuvant setting; however, this adjuvant treatment must not have included a CTLA4 or PD1 pathway blocking antibody or a BRAF/MEK inhibitor. Also, patients may not have had any prior systemic treatment for advanced (measurable metastatic) disease.
  9. Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting ≥ 4 weeks prior to entering the study and recovered from adverse events due to those agents. Mitomycin and nitrosoureas must have been discontinued at least 6 weeks prior to entering the study. Patients must have discontinued radiation therapy ≥ 2 weeks prior to entering the study and recovered from any adverse events associated with treatment. Prior surgery must be ≥ 4 weeks from registration and patients must be fully recovered from post-surgical complications.
  10. Patients must not receive any other investigational agents while on study or within four weeks prior to registration.
  11. Patients are ineligible if they have any currently active CNS metastases. Patients who have treated brain metastases (with either surgical resection or stereotactic radiosurgery (SRS)) that have been stable on head MRI or contrast CT scan for at least 4 weeks following treatment and within 4 weeks prior to 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 are ineligible.
  12. Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast. Patients with other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of registration. Patients with a history of RAS mutation-positive tumors are not eligible regardless of interval from the current study. Note: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility.
  13. Patients must not have any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above.
  14. Patients must not have a history of or evidence of cardiovascular risks.
  15. Individuals who are known to be HIV infected are ineligible (Note: HIV testing is not required for entry into the study).
  16. Patients with evidence of active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection are not eligible. Patients with cleared HBV and HCV infection will be allowed.
  17. Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded.
  18. The following medications or non-drug therapies are also prohibited while on treatment in this study:
    • Other anti-cancer therapies.
    • Other investigational drugs.
  19. Patients must not have history of retinal vein occlusion (RVO).
  20. Patients must not have evidence of interstitial lung disease or pneumonitis.
  21. Patients must not have malabsorption, swallowing difficulty, or other conditions that would interfere with the ingestion or absorption of dabrafenib or trametinib.

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