Study Comparing Amivantamab and FOLFIRI with Cetuximab/Bevacizumab and FOLFIRI in Colorectal Cancer Patients Without KRAS/NRAS and BRAF Mutations

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

ClinicalTrials ID:NCT06750094

This clinical trial is comparing two treatment options for patients with colorectal cancer that has returned, cannot be removed by surgery, or has spread to other parts of the body. The study focuses on patients whose cancer does not have certain genetic mutations (KRAS, NRAS, BRAF) and who have already received chemotherapy.

Patient Parameters

Program Overview

The aim of this study is to compare two treatment combinations to see which one is more effective in keeping the cancer from getting worse and in extending the lives of patients with colorectal cancer. The treatments being compared are: 1) Amivantamab combined with chemotherapy drugs 5-fluorouracil, leucovorin, and irinotecan (known as FOLFIRI), and 2) Either cetuximab or bevacizumab combined with FOLFIRI. This study is for patients whose cancer does not have KRAS, NRAS, or BRAF mutations and who have already been treated with chemotherapy.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of colon or rectal cancer that has come back, cannot be removed by surgery, or has spread to other parts of the body.
  • The cancer must not have KRAS, NRAS, or BRAF mutations, as determined by local testing.
  • Agree to provide a new or previous tumor sample after the most recent treatment, if possible.
  • Have cancer that can be measured by scans or tests.
  • Be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have received one previous treatment for metastatic colorectal cancer that included specific chemotherapy drugs, and the cancer must have shown signs of getting worse after this treatment.

Exclusion Criteria

  • Have a history of certain lung diseases like interstitial lung disease, pneumonitis, or pulmonary fibrosis, or currently have these conditions.
  • Have known allergies or intolerances to any of the study drugs or their components.
  • Have another type of cancer that could interfere with the study.
  • Have a specific genetic condition (mismatch repair deficiency or high microsatellite instability) and have not received immunotherapy.
  • Have a tumor that is positive for HER2.
  • Have previously been treated with irinotecan or drugs targeting EGFR or MET.

Locations

FACILITYZIPCITYSTATE
Cancer and Blood Specialty Clinic90720Los AlamitosCalifornia
Providence Medical Foundation95403Santa RosaCalifornia
AdventHealth Cancer Institute32804OrlandoFlorida
MedStar Franklin Square Medical Center21237BaltimoreMaryland
Cancer And Hematology Centers of Western Michigan PC49503Grand RapidsMichigan
Hattiesburg Clinic39401HattiesburgMississippi
Nebraska Cancer Specialists68130OmahaNebraska
MD Anderson Cancer Center77030HoustonTexas
Providence Regional Cancer System98503LaceyWashington

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