A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

Contact:

NCT Number:

Protocol:

AAAV6419

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

The purpose of this study is to compare the effects of two anticancer drugs (amivantamab and cetuximab) when each is given in combination with standard colorectal cancer (CRC) chemotherapies to participants with metastatic (cancerous) CRC that lack mutations in genes called KRAS/NRAS and BRAF. Amivantamab is an investigational drug in this study, meaning it is currently being tested and has not been approved by the United States Food and Drug Administration (FDA) for your disease. This is why amivantamab is being compared with cetuximab, an FDA-approved treatment, to evaluate its efficacy and safety in this clinical trial. Cetuximab, FOLFIRI and mFOLFOX6 (standard chemotherapy) is already used to treat participants with your type of cancer.

Are you Eligible? (Inclusion Criteria)

  • Be ≥18 years of age - Must have unresectable or metastatic disease - Must agree to the submission of fresh tumor tissue

Specialty Area(s)

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032