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 have been diagnosed with cancer of the colon or rectum, confirmed by laboratory testing of tissue or cell samples, where the tumour has a specific genetic change called a RAS mutation (in KRAS, NRAS, or HRAS), is classified as "microsatellite stable," and has a tumour mutational burden score of 10 or more.
• People whose cancer can be measured on scans using standard imaging guidelines.
• People who have already completed at least one round of treatment for cancer that has spread (metastatic disease), or whose cancer got worse during that treatment, and for whom no other standard treatments are likely to help.
• People who have waited at least 4 weeks since their last chemotherapy (or at least 6 weeks if that chemotherapy included specific drugs called nitrosoureas or mitomycin C), immunotherapy, or radiation therapy before joining the trial.
• People who have mostly or fully recovered from significant side effects caused by previous treatments before starting the trial.
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health scoring system (ECOG performance status of 0 or 1).
• People whose kidneys, liver, and blood counts are within acceptable ranges, based on recent blood tests taken within 16 days of starting treatment.
• People whose blood oxygen level while resting and breathing normal air is above 90%.

Who may not be able to join:

• People who are pregnant or currently breastfeeding.
• People who are receiving other cancer treatments at the same time, with some specific exceptions noted by the trial.
• People who have another serious illness that, in the trial doctor's opinion, could make it unsafe for them to participate.
• People who have dementia, a significant change in mental status, or a psychiatric condition that would prevent them from fully understanding and agreeing to participate.
• People who have active autoimmune diseases that currently require treatment (though people with certain stable conditions such as vitiligo, hair loss, or a stable autoimmune hormone condition on steady replacement therapy may still be considered).
• People who are regularly taking steroid medications by mouth or injection at significant doses, though low-level replacement doses or local steroids (such as nasal sprays or inhalers) and short-term limited doses for specific medical reasons may be acceptable.
• People who have taken part in another clinical trial and received an experimental treatment within the 28 days before starting this trial.
• People who have untreated cancer that has spread to the brain, or who have had treatment to the brain for cancer spread within the last 2 months (people with stable brain metastases for at least 2 months after treatment may be considered).
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or similar medicines, or to any ingredients in those medicines.
• People with serious or uncontrolled ongoing illness, such as active infection, significant heart problems, or other conditions that, in the trial doctor's opinion, would make it difficult to follow the trial requirements.
• People who are HIV-positive, due to concerns about reduced immune function.
• People who are unwilling to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) starting before the trial and continuing for 3 months after completing treatment.

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