Study on Regorafenib and Lorigerlimab Before Surgery for Lung-Limited Metastatic Colorectal Cancer
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT07137390
This clinical trial is testing a combination of two drugs, Regorafenib and Lorigerlimab, given before surgery to see if they can help control colorectal cancer that has spread only to the lungs. The study aims to evaluate the safety and effectiveness of this treatment approach.
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Program Overview
The purpose of this study is to determine if using Regorafenib and Lorigerlimab before surgery can help manage colorectal cancer that has spread to the lungs but not to other parts of the body. Researchers want to see if this combination can safely reduce the amount of cancer present before surgery and improve surgical outcomes.
Description
This study is divided into two phases: Phase Ib and Phase II.
In Phase Ib, researchers will assess the safety and tolerability of using Regorafenib and Lorigerlimab together before surgery in patients with colorectal cancer that has spread only to the lungs. The goal is to ensure that this combination is safe for patients and to determine the best dose to use.
In Phase II, the effectiveness of the treatment will be evaluated by examining how much the cancer shrinks before surgery. Researchers will also look at the rate of major pathological response, which means the percentage of cancer cells that remain after treatment and surgery.
The study will also measure the overall response rate to the treatment and the success rate of complete surgical removal of the cancer. Additionally, researchers will summarize the percentage of tumor viability, or how much of the tumor is still alive, at the time of surgery.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a confirmed diagnosis of colorectal cancer that has spread only to the lungs.
- Have a specific genetic profile (MSS or pMMR) as determined by standard tests.
- Be willing to undergo a biopsy of a lung tumor before starting treatment.
- Be considered a suitable candidate for surgery to remove the lung tumors.
- Have had the primary colorectal tumor treated before joining the study, with no signs of recurrence.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Have at least one measurable lung tumor.
- Have adequate organ and bone marrow function as determined by specific blood tests.
- Have adequate heart function if there is a history of heart disease.
- Agree to use effective contraception during the study and for a specified period after treatment if of childbearing potential.
- Be able to understand and sign a written informed consent document.
- Be able to swallow and retain pills.
Exclusion Criteria
- Have cancer that has spread to other parts of the body outside the lungs.
- Have received certain cancer treatments within a specified time before starting the study.
- Have a history of treatment with specific immune therapies or drugs targeting T-cell pathways.
- Have received non-palliative radiotherapy within 12 weeks before starting the study.
- Have an active condition requiring systemic treatment with corticosteroids or other immunosuppressive medications.
- Have gastrointestinal issues that may affect the absorption of the study drugs.
- Have a history of certain autoimmune diseases or conditions requiring recent steroid treatment.
- Have a history of severe allergic reactions to similar therapies.
- Have had a major surgical procedure or significant injury within 28 days before starting the study.
- Have other active cancers or have had certain cancers within the last 3 years.
- Be pregnant or breastfeeding.
- Be taking certain medications that may interact with the study drugs.
- Have active infections like hepatitis B, hepatitis C, tuberculosis, or HIV unless well-controlled.
- Have a history of organ transplant or certain heart conditions.
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