A Study to Evaluate MM-151, Nal-IRI, 5-FU, and Leucovorin for RAS/RAF Wild-Type Metastatic Colorectal Cancer


NCT ID: NCT02785068
Sponsor Protocol Number: MM-151-06-12-04

About this study

The purpose of this study is to evaluate the safety, effectiveness and drug/body interactions of the combination of MM-151, nal-IRI, 5-FU, and leucovorin for the treatment of RAS/RAF wild-type (genetic mutations), metastatic, colorectal cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Must be greater than 18 years of age
  • Must be able to provide informed consent
  • Must have KRAS/NRAS/BRAF wild-type colorectal cancer
  • Is willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 120 days following the last dose of any study therapy
    • Applies to women of childbearing potential as well as fertile men and their partners

Exclusion Criteria

  • Has had previous pelvic radiation treatment
  • Pregnant or lactating
  • Untreated (primary) or uncontrolled Central Nervous System (CNS) (primary or metastatic) malignancies
    • CNS metastases that have undergone surgery or radiotherapy or have been on a stable dose of corticosteroids for at least 2 weeks, and with stable disease prior to the first scheduled day of dosing will be eligible for the trial
  • History of any second malignancy in the last 3 years 
    • Prior history of in-situ cancer or basal or squamous cell skin cancer are eligible
  • Has received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days or bevacizumab within 28 days, and has passed the time of any actual or anticipated toxicities prior to the first scheduled dose of the study treatment

More information


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