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
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
| Parameter | Options |
|---|
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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cancer and Blood Specialty Clinic | 90720 | Los Alamitos | California |
| Providence Medical Foundation | 95403 | Santa Rosa | California |
| AdventHealth Cancer Institute | 32804 | Orlando | Florida |
| MedStar Franklin Square Medical Center | 21237 | Baltimore | Maryland |
| Cancer And Hematology Centers of Western Michigan PC | 49503 | Grand Rapids | Michigan |
| Hattiesburg Clinic | 39401 | Hattiesburg | Mississippi |
| Nebraska Cancer Specialists | 68130 | Omaha | Nebraska |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
| Providence Regional Cancer System | 98503 | Lacey | Washington |
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