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 able to understand and voluntarily sign a consent form agreeing to take part in the study.
• People who are 18 years of age or older on the day they sign the consent form, of any gender.
• People who have been diagnosed with colorectal cancer (a type of bowel cancer called adenocarcinoma, including specific subtypes called signet ring cell carcinoma and mucinous adenocarcinoma), confirmed through a tissue test.
• People who have at least one tumour that can be measured or assessed on scans at the start of the study. If there is only one such tumour, it must not have previously been treated with radiation, or must show clear signs of having grown after radiation treatment ended.
• People whose general health and ability to carry out daily activities is rated as fully active or restricted in strenuous activity but able to do light work (rated 0 or 1 on a standard medical scale called ECOG).
• People who are expected to live for at least 3 months.
• People for whom stored tumour tissue samples, or freshly collected tumour tissue samples, are available.
• People who are able and willing to attend all required study visits, follow the treatment plan, and complete all study-related tests and procedures.
• People whose blood, kidney, and liver tests show that these organs are working well enough within 7 days before starting treatment (specific lab value thresholds apply — confirm with trial site).
• People whose cancer history and prior treatments match the requirements for one of three specific groups (called cohorts) in the trial:
  • Group A: People with a certain type of advanced bowel cancer (pMMR/MSS) without a specific gene change called BRAF V600E, whose cancer has stopped responding to standard chemotherapy drugs (fluoropyrimidine, oxaliplatin, and irinotecan), and who do not have active cancer spread to the liver at the time of joining.
  • Group B: People with the same type of advanced bowel cancer (pMMR/MSS) but with the BRAF V600E gene change, whose cancer has also stopped responding to those same standard chemotherapy drugs.
  • Group C: People with a certain type of advanced bowel cancer (MSS) who have not received, or are unable to receive, or have chosen not to receive standard first- or second-line chemotherapy.
• People who are able to use highly effective contraception from 7 days before the first dose until 120 days after the last dose (applies to women who could become pregnant and men whose partners could become pregnant). Women who could become pregnant must also have a negative blood pregnancy test within 7 days before the first dose.

Who may not be able to join:

• People with untreated brain or spinal fluid metastases (cancer that has spread to the brain or surrounding tissue). People whose brain metastases have been treated and have been stable for at least 4 weeks, with no new or worsening neurological symptoms, may still be considered.
• People who have had a hole (perforation) or abnormal channel (fistula) in their digestive tract within the 6 months before starting the study — unless it has been surgically repaired and the doctor considers it fully healed.
• People who have taken part in another clinical trial or received any other cancer treatment within 28 days (or within 5 half-lives of the drug, whichever is shorter) before starting the study. Radiation therapy used to relieve pain from bone metastases is allowed.
• People who have had major surgery within 28 days before starting the study (for example, major abdominal or chest surgery; minor procedures such as drainage or diagnostic biopsies are generally allowed).
• People who have needed ongoing high-dose steroid tablets or injections for immune suppression for 7 or more days within the 14 days before starting the study. Inhaled steroids, locally applied steroids, low-dose steroids for hormone replacement, or short-term steroids to prevent allergic reactions are generally allowed.
• People who have received a live vaccine (including weakened live vaccines) within 28 days before starting the study.
• People who have a lung disease called interstitial lung disease, or a history of non-infectious lung inflammation that required steroid treatment.
• People who have had an active autoimmune disease (a condition where the immune system attacks the body) requiring treatment within the past 2 years, or who are considered at risk of it returning. Some milder autoimmune-related conditions may be acceptable — confirm with trial site.
• People who have had another type of cancer in the past 5 years. Certain fully treated, low-risk cancers may be acceptable (such as some skin cancers, non-invasive bladder cancer, early-stage prostate cancer, cervical or breast cancer that has not spread, or Lynch syndrome) — confirm with trial site.
• People with uncontrolled serious health conditions, including but not limited to: active hepatitis B or C infection (with some exceptions based on test results), known HIV or AIDS, active tuberculosis, an active infection requiring more than one week of antibiotics or antiviral drugs in the past 28 days, unexplained fever in the past 2 weeks, very high blood pressure that cannot be controlled, serious heart conditions, or active bleeding that cannot be stopped with medical treatment.
• People who still have significant side effects from previous cancer treatments that have not returned to a mild level or to their pre-treatment state (with some exceptions such as hair loss and certain hormone-related side effects).
• People who have previously received a bone marrow or organ transplant from another person.
• People who have had serious allergic reactions or intolerances to antibody-based medications in the past.
• People who are pregnant or breastfeeding.
• People with other conditions that the trial doctor believes could affect their safety or ability to follow the study plan, such as significant fluid build-up around the lungs, heart, or abdomen, bowel obstruction, or serious mental health conditions.
• People who have previously been treated with immune checkpoint inhibitor drugs (such as PD-1, PD-L1, CTLA-4, LAG3 inhibitors, or therapeutic cancer vaccines).
• People who have previously been treated with a drug called regorafenib.

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