Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from the 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 newly diagnosed with locally advanced rectal cancer (confirmed by tissue testing), at a stage that their doctor has classified as Stage 2 or 3, or Stage 1 where surgery to preserve the sphincter muscle is not possible, and whose treatment plan includes a short course of radiation before surgery.
• People aged 18 or older.
• People whose general health and ability to carry out daily activities meets a certain minimum level, as assessed by their doctor (called ECOG performance status 0, 1, or 2 — confirm with trial site).
• People whose blood counts and organ function meet specific minimum levels, including healthy enough levels of white blood cells, platelets, haemoglobin, liver enzymes, bilirubin, and kidney function (confirm exact values with trial site).
• For people enrolling at Washington University or Dana Farber Cancer Institute only: people willing to have tumour biopsies taken during the study, provided it is safe and appropriate to do so as determined by the treating doctor.
• People who are willing to use reliable contraception methods throughout the study and for 120 days after the last dose of study treatment, as described in the study protocol.
• People who are able to understand and sign a written consent form approved by an ethics review board (or have a legally authorised representative do so on their behalf).

Who may not be able to join:

• People who have previously received any cancer treatment for rectal cancer.
• People who have previously been treated with any drug that targets the IDO pathway, including indoximod.
• People who have had radiation therapy to the pelvic area before, previous rectal surgery (such as TEM), or any experimental treatment for rectal cancer within the past month.
• People who have, or are suspected to have, another cancer that could be confused with their rectal cancer during assessments.
• People currently taking part in another clinical trial involving an experimental treatment.
• People whose cancer has grown extensively into the upper part of the sacrum (above a specific bone level) or into the nerve roots in that area, making surgery unlikely even if the tumour shrinks (confirm with trial site).
• People whose cancer has spread to other parts of the body (metastatic disease) or whose rectal cancer has returned after previous treatment.
• People diagnosed with certain inherited or inflammatory bowel conditions, including Familial Adenomatous Polyposis (FAP), Lynch syndrome (HNPCC), active Crohn's disease, or active ulcerative colitis.
• People who have had allergic reactions to any of the drugs used in this study, or to drugs with a similar chemical make-up.
• People who currently have an active infection that requires treatment with medication taken by mouth or through a drip.
• People currently taking warfarin (Coumadin). People who have stopped taking warfarin and whose blood clotting levels have returned to normal may still be considered (confirm with trial site).
• People who have ever experienced serotonin syndrome after taking certain medications, including MAOIs, meperidine, linezolid, or methylene blue. These medications are also not allowed during the study.
• People with serious uncontrolled health conditions, including active tuberculosis, lung inflammation requiring treatment, poorly controlled heart failure, unstable chest pain, or heart rhythm problems.
• People who have an active or inactive autoimmune or inflammatory condition (such as rheumatoid arthritis, moderate to severe psoriasis, multiple sclerosis, or inflammatory bowel disease) that has needed systemic treatment in the past two years, or who are currently receiving systemic treatment for such a condition. Some exceptions apply, including vitiligo, well-controlled thyroid conditions, controlled asthma, Type 1 diabetes, and certain other stable conditions (confirm with trial site).
• People whose heart tracing (ECG) shows an abnormality that the doctor considers clinically significant.
• People with a digestive condition that may affect how the body absorbs medication.
• People who have received a live vaccine within 30 days before starting the study treatment. This includes vaccines for measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and typhoid. Most standard flu injections are allowed, but nasal spray flu vaccines (such as FluMist) are not.
• People who are pregnant or breastfeeding. Women who could become pregnant must have a negative pregnancy test within 7 days of the planned start of treatment.
• People with a known active hepatitis B or hepatitis C infection, confirmed by blood testing required at screening.
• People whose rectal cancer has been found to have a specific genetic feature known as microsatellite instability-high (MSI-H) or mismatch repair deficiency.

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