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Protocol No. UW17113

Principal Investigator Deming, Dustin

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Study of Nivolumab in Combination With Trametinib With or Without Ipilimumab in Participants With Previously Treated Metastatic Colorectal Cancers

Objective The purpose of the study is to find the best dose schedule of trametinib in combination with nivolumab and ipilimumab for the treatment of metastatic colorectal cancer. The study will also look at how effective and safe this combination of investigational drugs is. The combination of trametinib, nivolumab, and ipilimumab is considered experimental. This means that the US Food and Drug Administration (FDA) has not approved this combination for the treatment of metastatic colorectal cancers and can only be given in a research study.

Treatment Patient's will receive nivolumab, ipilimumab and trametinib. They will receive nivolumab by IV infusion every 4 weeks and ipilimumab by IV every 8 weeks. The period between each ipilimumab infusion is called a cycle (8 weeks). They will be assigned to either take trametinib tablets orally every day on a continuous basis or you will take trametinib tablets every day for 2 weeks and then 2 weeks off.

Description This study is being done to find the best dose schedule of trametinib in combination with nivolumab and ipilimumab for patients with metastatic colorectal cancer

Key Eligibility
  • Histologically or cytologically confirmed previously treated metastatic colorectal cancer with adenocarcinoma histology and in Stage IV
  • Patients with 3rd line mCRC must have progressed or been intolerant to two prior lines of chemotherapy in the metastatic disease setting which must include at least a fluoropyrimindine and oxaliplatin- and irinotecan- containing regimens
  • Patients with 2nd line mCRC must have progressed or been intolerant to one prior line of chemotherapy in the metastatic disease setting which must include at least a fluoropyrimindine and oxaliplatin- or irinotecan- containing regimens
  • systemic therapy in the adjuvant setting is ok if progression occurred at least 6 months after the last dose of the adjuvant therapy
  • Adjuvant therapy or maintenance therapy will NOT be considered as one line of prior therapy for study entry
  • Patients who received FOLFOXIRI (or equivalent) in the first-line setting may be considered for enrollment in the doublet regimen, but not the triplet regimen
  • Must have measurable disease
  • ECOG performance status of 0-1
  • Women must not be pregnant or breastfeeding
  • Male and Females of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of study treatment and 5 months after the last dose of study treatment
  • Adequate hematology, renal and liver function
  • Albumin >3 g/dL
  • No hepatitis B or C, HIV or AIDS
  • BRAF V600 mutant colorectal cancer are NOT eligible for this study
  • No Active brain metastases or leptomeningeal metastases
  • No prior secondary malignancy within the previous 3 years <
  • No prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
  • No prior treatment with any MEK inhibitor
  • No history of interstitial lung disease or pneumonitis
  • No history or evidence of cardiovascular risk

  • Applicable Disease Sites Colon and Rectum

    Status Open

    Participating Institutions UW Hospital and Clinics