Phase 2 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:

• You are between 18 and 75 years old
• You have been diagnosed with squamous cell carcinoma (a specific type of cancer) of the anal canal or the skin area around the anus, confirmed by a pathology test
• You are generally well enough to carry out daily activities with little or no help, and your doctors expect you to live at least 3 more months
• Your blood cell counts, liver, kidneys, thyroid, and clotting function are all within acceptable ranges based on blood tests (confirm with trial site)
• You do not have any serious other illnesses that would be expected to shorten your life to less than 5 years
• If you could become pregnant, you have had a negative pregnancy test; or you are not able to become pregnant
• If you are sexually active and could father or become pregnant, you agree to use effective contraception throughout the study and for 12 months after treatment ends
• You are willing and able to attend appointments, follow the treatment plan, and complete required tests and procedures
• You do not currently need to take hormone replacement therapy as a medical requirement
• You have read and signed a consent form showing you understand what the study involves

Additionally, each group (cohort) has its own extra requirements:

• Group 1: Your tumor is smaller than 5 cm and has not spread to nearby lymph nodes, and you have not had any cancer treatment before
• Group 2: After having the tumor surgically removed, no cancer can be detected on examination or scans, and you have not had any cancer treatment before (including radiation, chemotherapy, or immunotherapy)
• Group 3: Your tumor is 5 cm or larger, has grown into nearby organs, or has spread to nearby lymph nodes — and you have not had any cancer treatment before
• Group 4: Your cancer has spread to distant parts of the body (such as the liver, lungs, or bones), or it has come back in the pelvic area after previous treatment, with or without spread to other parts of the body

Who may not be able to join:

• Your anal tumor is a different type than squamous cell carcinoma (for example, lymphoma or melanoma)
• You have previously been treated with certain types of immunotherapy drugs that target PD-1, PD-L1, or CTLA-4
• You have or have had another type of cancer, unless it was a very limited skin cancer, early-stage cervical cancer, or a certain type of thyroid cancer that was fully treated
• You have an active autoimmune disease (where the immune system attacks the body), or have had one in the past — with some exceptions such as stable thyroid conditions, type 1 diabetes well controlled on insulin, vitiligo, or childhood allergies that cleared up on their own
• You have a weakened immune system, a history of HIV, or have had an organ or bone marrow transplant
• You have a history of a lung disease called interstitial lung disease, or have had lung inflammation that was not caused by infection (with some exceptions — confirm with trial site)
• You have active tuberculosis (TB) now or within the past year, or had TB more than a year ago that was never properly treated
• You have active hepatitis B or hepatitis C infection (based on specific blood test results — confirm with trial site)
• You have serious heart, lung, liver, or kidney problems
• You have a history of misusing alcohol, drugs, or other substances
• You have any other medical, mental health, or personal situation that the study doctor feels would put you at risk or make it difficult to safely take part in the trial

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