Study on MK-1084 with Targeted Therapy and Chemotherapy for Colorectal Cancer
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06997497
This clinical trial is exploring a new treatment combination for people with advanced colorectal cancer that cannot be removed by surgery and has a specific gene mutation called KRAS G12C. The study aims to find out if adding MK-1084 and cetuximab to standard chemotherapy can improve outcomes for these patients.
Patient Parameters
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Program Overview
Researchers are testing a new treatment approach for people with advanced colorectal cancer that cannot be surgically removed and has a KRAS G12C gene mutation. The standard treatment for this type of cancer usually includes chemotherapy drugs mFOLFOX6, sometimes with bevacizumab. This study is investigating whether adding two targeted therapies, MK-1084 and cetuximab, to the standard chemotherapy can help control the cancer better. The main goals are to see if this combination is safe, if patients can tolerate it, and if it helps them live longer without the cancer growing or spreading.
Description
This study will be conducted in two parts. The first part will focus on evaluating the safety and tolerability of the new treatment combination, while the second part will assess its effectiveness in controlling the cancer. Participants will receive the study medications and undergo regular health checks to monitor their response to the treatment. The study aims to provide insights into whether this new combination can offer better outcomes for patients with advanced colorectal cancer that has the KRAS G12C mutation.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced colorectal cancer that cannot be removed by surgery.
- For Part 2: Have not received any previous treatment for advanced colorectal cancer.
- Have a tumor with the KRAS G12C mutation.
- If living with HIV, must have well-controlled HIV on antiretroviral therapy.
- If positive for Hepatitis B, must be on antiviral therapy with undetectable viral load.
- If previously infected with Hepatitis C, must have an undetectable viral load.
Exclusion Criteria
- Have active inflammatory bowel disease requiring medication or a history of such conditions.
- Have uncontrolled heart or blood vessel diseases.
- Have a known deficiency in dihydropyrimidine dehydrogenase (DPD).
- If living with HIV, must not have a history of Kaposi's sarcoma or Multicentric Castleman's Disease.
- Have received any cancer treatment or investigational drugs within 4 weeks before starting the study.
- Have conditions that make treatment with bevacizumab unsuitable.
- Have another active cancer that is progressing or needed treatment in the last 3 years.
- Have cancer that has spread to the brain or spinal cord.
- Have an active infection needing treatment.
- Have not fully recovered from major surgery or have ongoing surgical issues.
- Have a history of lung inflammation that required steroids or currently have lung disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Orlando Health Cancer Institute ( Site 0065) | 32806 | Orlando | Florida |
| Norton Cancer Institute, Audubon Hospital Campus ( Site 0054) | 40217 | Louisville | Kentucky |
| Renown Regional Medical Center ( Site 0056) | 89502 | Reno | Nevada |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060) | 07601 | Hackensack | New Jersey |
| Miami Valley Hospital South ( Site 0075) | 45459 | Centerville | Ohio |
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