Testing Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma

August 08, 2017
EA6134
Melanoma
Samir Undevia, MD

Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

The purpose of this study is to compare the good and bad effects of the sequence of immunotherapy followed by BRAF inhibitor therapy if and when the disease becomes resistant, to the sequence of BRAF inhibitor therapy followed by immunotherapy if and when the disease becomes resistant. 

Sponsor: Eastern Cooperative Oncology Group (ECOG)

https://clinicaltrials.gov/ct2/show/NCT02224781

  • Over age of 18
  • Patients must have unresectable stage III or stage IV disease
  • Patients must have measurable disease; all sites of disease must be evaluated within 4 weeks prior to randomization
  • 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
  • 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
  • Patients must not receive any other investigational agents while on study or within four weeks prior to registration
  • Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive

    NOTE: Any patient with BRAF V600 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 eligible for this trial
  • Patients must have BRAF V600 mutation

5 years

Accepting Participants
Interventional
III
Kathy Seymour, BSN
630-646-6075
630-646-6110
630-646-6072