Early Phase 1 Colorectal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with colon or rectal cancer confirmed by a tissue biopsy, with pathology records available for review.
• People whose cancer has been classified as stage III (meaning it has spread to nearby lymph nodes but not to distant parts of the body), based on standard cancer staging guidelines.
• People whose cancer was fully removed by surgery, with no cancer cells detected at the edges of the removed tissue, and no signs of cancer spread to other organs on recent scans.
• People who started planning for this trial within a set timeframe after their surgery (roughly 4 to 12 weeks), to allow time to recover.
• People whose tumour has been tested and confirmed to be a specific type called MSS or pMMR (meaning the cancer's DNA repair system is working normally), confirmed through standard laboratory testing.
• People whose cancer has at least one feature that puts them at higher risk of the cancer returning, such as a tumour that grew into surrounding structures (T4), four or more positive lymph nodes (N2), a positive ctDNA blood test after surgery (a sign of possible remaining cancer cells), or other high-risk features such as cancer found in blood or nerve vessels, or poorly differentiated tumour cells (confirm with trial site).
• People who are considered suitable by their doctor to receive a standard chemotherapy combination containing oxaliplatin, given as either mFOLFOX6 or CAPOX over several months.
• People who have no known medical reasons that would prevent them from receiving the chemotherapy drugs oxaliplatin, 5-fluorouracil, leucovorin, or capecitabine (for example, no severe enzyme deficiency affecting how the body processes these drugs).
• People whose doctor judges them suitable to receive an immunotherapy drug called nivolumab, with no history of serious immune-related side effects from previous immunotherapy and no active immune system condition requiring ongoing suppressive treatment.
• People who are in generally good physical condition and able to carry out daily activities, rated 0 or 1 on a standard medical fitness scale (ECOG scale).
• People whose blood, liver, and kidney results fall within acceptable ranges on tests taken within 14 days before joining the trial.
• People who have a stored tumour tissue sample available from their surgery (either fresh frozen tissue, a preserved tissue block, or at least 15 prepared tissue slides), as well as a blood sample for genetic testing.
• People who are willing to provide additional blood samples during the trial for research testing.
• People whose tumour analysis through the trial's specialised pipeline (called COLONYVAQ) has identified at least one suitable target for the personalised vaccine, or for whom pre-made vaccine materials are already available that have met safety and effectiveness standards.
• People whose doctor estimates they are likely to live at least 3 years if the cancer does not return.
• Women who could become pregnant must have a negative pregnancy test within 7 days before joining, and must agree to use reliable contraception during treatment and for a set period afterward.
• Men with partners who could become pregnant must agree to use effective contraception and not donate sperm during treatment and for a set period afterward.
• People who are able to understand and sign a written consent form and are willing and able to attend all required visits, scans, and follow-up appointments.

Who may not be able to join:

• People whose surgery did not fully remove the cancer, where cancer cells were found at or near the edges of the removed tissue, or where distant spread was detected on scans or biopsy.
• People whose tumour has been identified as the dMMR, MSI-H, or POLE ultramutated type, as these tumour types have different standard treatment options.
• People who have previously received systemic treatment for advanced or metastatic bowel cancer.
• People who received pre-surgery chemotherapy or chemoradiotherapy that was not completed within the required timeframe, or that caused side effects of grade 2 or higher that have not resolved (with some exceptions such as hair loss).
• People who have previously received any type of cancer vaccine (including peptide, RNA, DNA, or cell-based vaccines targeting tumour-specific proteins or mutations).
• People who have previously received immune checkpoint inhibitor drugs (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies).
• People with an active or poorly controlled infection requiring ongoing antibiotic treatment, or uncontrolled HIV, active hepatitis B or C infections.
• People with a severe or uncontrolled autoimmune condition requiring strong immune-suppressing treatment (such as high-dose steroids or biologic medications), including conditions such as lupus, active inflammatory bowel disease, rheumatoid arthritis requiring biologics, multiple sclerosis, or myasthenia gravis. Some stable autoimmune conditions may be acceptable (confirm with trial site).
• People taking corticosteroid medicines at a dose above 10 mg prednisone equivalent per day (or similar immune-suppressing drugs) within a set period before starting the trial, unless taken for a specific medical reason such as hormone replacement.
• People who have had a bone marrow or stem cell transplant from a donor, or a solid organ transplant such as a kidney, liver, or heart.
• People with a known severe allergic reaction (such as anaphylaxis) to any of the trial drugs or their ingredients, including the vaccine components, nivolumab, or any of the chemotherapy drugs.
• People with another active cancer that requires or is expected to require systemic treatment during the trial period. Certain past or minor cancers may be acceptable (confirm with trial site).
• People with significant heart conditions diagnosed within the past six months, including heart attack, unstable chest pain, uncontrolled abnormal heart rhythms, or severe heart failure, or uncontrolled high blood pressure.
• People who have had a stroke or mini-stroke within the past six months where the treating doctor considers the risk to be too high.
• People with severe lung disease, including significant chronic obstructive lung disease or a history of lung inflammation requiring steroid treatment.
• People with other serious uncontrolled medical conditions that the trial team believes could affect safety or the ability to participate reliably.
• People who are pregnant at the time of screening.
• People who are breastfeeding (breastfeeding would need to stop before starting the trial).
• People currently participating in another interventional clinical trial involving experimental treatments, unless specifically approved by the trial sponsor.
• People who have received a live vaccine within approximately 30 days before starting the trial or who would need one during the trial.
• People with a psychiatric illness, cognitive difficulties, substance use issues, or personal circumstances that could make it difficult to follow the trial requirements.
• People whom the trial investigator believes, for any reason, would not be suitable or safe to participate.

Important: Always verify eligibility with the trial site directly before applying.