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:

• People who are willing and able to sign a written consent form agreeing to take part in the study.
• People who have been diagnosed with a specific type of advanced (metastatic) colorectal cancer confirmed by laboratory testing — known as pMMR or MSS mCRC (confirm with trial site for what this means for a specific case).
• People aged 18 or older, of any gender.
• People whose doctors estimate they have a life expectancy of more than 12 weeks.
• People who are generally well enough to carry out light activities — scoring 0 or 1 on a standard health performance scale used by doctors (ECOG score less than 2).
• People whose cancer can be measured on a CT or MRI scan of the chest, abdomen, and pelvis using standard medical criteria.
• People who have previously received 1 or 2 chemotherapy treatment plans for advanced disease, which may have included certain standard medicines such as fluoropyrimidines, irinotecan, oxaliplatin, and/or targeted antibody treatments (where appropriate for their tumour type).
• People whose blood counts and organ function (including liver and kidneys) fall within acceptable ranges as determined by standard blood tests.
• People whose tumour tissue sample, removed during surgery, has already been collected, sent to the designated laboratory (IRCCS IRST), and meets the required quality standards for making the study vaccine.
• People who have recovered well from any side effects of previous surgery (side effects at grade 1 or lower on a standard medical scale).
• People who are suitable for a blood collection procedure called leukapheresis — meaning they have tested negative for certain infections (HIV, hepatitis B, hepatitis C, and syphilis), have acceptable heart test results, and have been assessed by a specialist to confirm there are no reasons to avoid this procedure.
• Women who are not pregnant and not breastfeeding. Women who could become pregnant, and all men, must agree to use a highly effective method of contraception during the study.

Who may not be able to join:

• People who have previously been treated with a medicine called FTD/TPI for advanced colorectal cancer.
• People who have had chemotherapy or radiotherapy within the 4 weeks before joining the study, or who have not yet recovered from side effects of earlier treatments.
• People who have taken part in another clinical trial involving an experimental treatment within the 30 days before screening for this study.
• People who have cancer that has spread to the brain.
• People with a history of serious allergic reactions to medicines that are chemically or biologically similar to Pembrolizumab, FTD/TPI, Bevacizumab, or the components of the study vaccine.
• People with a history of immune system deficiency — whether present from birth or developed later — including people who have had an organ transplant.
• People with an active inflammatory or autoimmune condition (where the immune system attacks the body) that requires ongoing treatment with steroids or other medicines that affect the immune system.
• People with other serious uncontrolled health conditions, such as an active infection, severe heart problems, uncontrolled heart rhythm issues, or mental health or personal circumstances that would make it difficult to follow the study requirements.
• People who have had another type of cancer within the last 5 years (with the exception of certain previously treated skin cancers or early-stage cervical cancer).

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