Preoperative Immunotherapy (Pembrolizumab) for Colorectal Cancer with Liver Metastases That Can Be Surgically Removed
Sponsor: Chloe Atreya, MD, PhD
ClinicalTrials ID:NCT03844750
This study is testing how well the immunotherapy drug pembrolizumab, combined with vactosertib, works after standard chemotherapy in patients with colorectal cancer that has spread to the liver and can be surgically removed. The goal is to see if this combination can shrink the cancer before surgery and reduce the risk of it coming back after surgery.
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Program Overview
This phase II study is exploring the effectiveness of pembrolizumab and vactosertib after standard chemotherapy in patients with colorectal cancer that has spread to the liver and can be surgically removed. Pembrolizumab is an immunotherapy drug that may help the immune system attack cancer cells, while vactosertib may block enzymes needed for cancer cell growth. The study aims to see if this combination can shrink tumors before surgery and lower the chance of cancer returning after surgery.
Description
The main goal of this study is to understand how pembrolizumab and vactosertib affect immune cells within tumors in patients with colorectal cancer that has spread to the liver. Researchers also want to ensure the treatment is safe and effective in this setting.
Participants will receive pembrolizumab through an IV and take vactosertib pills. This treatment is given after standard chemotherapy but before surgery to remove liver tumors. After surgery, some patients may continue receiving pembrolizumab and vactosertib every six weeks for up to a year if they are eligible.
The study will monitor changes in immune cells and tumor characteristics to understand how the treatment works. Participants will be followed up regularly to check their health and the treatment's impact.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with colorectal cancer that has spread to the liver, with or without other metastases.
- Previously received oxaliplatin-based chemotherapy.
- Suitable for liver biopsy and surgery to remove liver metastases.
- Able to provide written consent for the trial.
- Aged 18 years or older.
- Have measurable disease based on specific criteria.
- Willing to provide a new tumor sample for analysis.
- Have a performance status indicating good overall health.
- Have adequate organ function based on blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Men must agree to use contraception during the study.
- Have microsatellite stable or mismatch repair proficient colorectal cancer.
- No evidence of cancer on scans for the adjuvant phase.
Exclusion Criteria
- Currently participating in another study or received an investigational treatment recently.
- Have an immune deficiency or are on high-dose steroids or immunosuppressive therapy.
- Have a history of HIV infection.
- Have an active autoimmune disease requiring treatment in the past two years.
- Have active hepatitis B or C infection.
- Received certain cancer treatments recently.
- Have not recovered from previous treatments or surgeries.
- Have had liver-directed therapy recently.
- Have another progressing cancer or required treatment for another cancer recently.
- Have active brain metastases or meningitis.
- Have a history of lung inflammation requiring steroids.
- Have an active infection needing treatment.
- Have a condition that could interfere with the study.
- Have psychiatric or substance abuse issues affecting participation.
- Have received prior immunotherapy targeting specific immune checkpoints.
- Have severe allergies to pembrolizumab.
- Have received a live vaccine recently.
- Have certain heart or liver conditions.
- Have had a transplant or have uncontrolled health issues.
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