Phase 2 Liver 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 are 18 years of age or older.
• People who are generally well enough to carry out light activity or desk work (a doctor would assess this using a standard scale).
• People who are willing to allow the trial team to access stored tumour tissue, past scan results, and tumour marker data if these exist.
• People who are able to swallow tablets and are willing to keep a daily record of whether they took the study drug.
• People with an estimated life expectancy of at least 3 months, based on the treating doctor's assessment.
• People who are willing and able to attend all scheduled visits, follow all treatment plans, and complete all required tests and procedures.
• People whose cancer can be measured on scans using standard methods.
• People who have a confirmed advanced or metastatic solid tumour cancer for which no further standard treatment is available, no standard treatment exists, who have been offered and declined standard treatment, or who cannot tolerate standard treatment.
• Women who are not able to become pregnant, or — if they could become pregnant — those who have a negative pregnancy test, use a highly effective method of contraception combined with a condom, and agree not to donate eggs for the period specified in the trial protocol.
• Men who agree to use a condom, and whose female partner also uses a highly effective method of contraception for the period specified in the trial protocol (if their partner could become pregnant), and who agree not to donate sperm.

For certain parts of the trial (Module 1 Part B and Module 2 Part B):

• People who have at least one tumour that can be safely biopsied multiple times, and who consent to those biopsies, with additional measurable tumours separate from the biopsy site.

For the cervical cancer group (Module 2, Cohort 1):

• People with confirmed persistent, returning, or metastatic cervical cancer that cannot be cured.
• People who have received at least 3 months of a first-line immunotherapy treatment (with or without other medicines), and whose cancer did not progress for at least 10 weeks during that treatment.
• People who are enrolling immediately after their cancer progressed on that immunotherapy, or who have had one additional line of cancer treatment since then.

For the liver cancer group (Module 2, Cohort 2):

• People with confirmed hepatocellular carcinoma (a type of liver cancer) that cannot be cured and is not suitable for local treatments targeting the liver.
• People who have received at least 3 months of a first-line immunotherapy-containing treatment, with at least 10 weeks without cancer progression during that time.
• People who are enrolling immediately after progression on immunotherapy, or who have had one additional line of cancer treatment since then.
• People whose liver is functioning at a level rated as Child-Pugh class A (a measure of liver health — confirm with trial site).

For the moderate-to-high tumour mutation group (Module 2, Cohort 3):

• People with confirmed advanced, returning, or metastatic disease in one of up to five specific cancer types known to have moderate-to-high tumour mutation levels (these include certain lung, bladder, head and neck, stomach, and oesophageal cancers — confirm specific cancer type eligibility with trial site).
• People who have received at least 3 months of first-line immunotherapy (with or without other medicines), with at least 10 weeks without progression.
• People enrolling immediately after progression on immunotherapy, or who have had one additional line of treatment since then.

For the colorectal cancer group (Module 2, Part D):

• People with confirmed colorectal cancer of a specific molecular type (called pMMR/MSS — confirm with trial site) that cannot be surgically removed, and who have no current or past spread to the liver.
• People who have received at least one prior treatment for advanced or metastatic disease, in line with local standard practice, unless ineligible or unable to tolerate it.
• People who have received no more than two prior chemotherapy treatments.

Who may not be able to join:

• People who have previously been treated with a type of drug called an ERAP1 inhibitor.
• People who have had another cancer within the past 3 years, with the exception of certain types of early cervical cell changes or non-melanoma skin cancers.
• People with unresolved side effects from previous treatment (above a mild level), except for certain stable or permanent effects such as hair loss or nerve tingling, which may be permitted (confirm with trial site).
• People with an active or recent history (within 2 years) of an autoimmune disease requiring immune-suppressing medication, or those whose immune system is weakened for any other reason.
• People with spinal cord compression or cancer that has spread to the brain, unless it is stable, causing no symptoms, and has not required steroid treatment for at least 4 weeks.
• People with uncontrolled seizures.
• People with an active infection requiring treatment within 14 days before starting the study drug.
• People with severe or uncontrolled medical conditions (such as severe lung disease, severe Parkinson's disease, or active inflammatory bowel disease) or severe psychiatric conditions.
• People with active bleeding disorders.
• People who have had an organ transplant.
• People with a known active hepatitis B, hepatitis C, or HIV infection.
• People who are pregnant or breastfeeding.
• People who have received cancer treatments (certain types) within 28 days or within 5 half-lives of the drug, whichever is shorter, before starting the study drug.
• People who have taken oral corticosteroid medication (such as prednisone) at doses above 10 mg per day within the past 14 days, unless taken for adrenal insufficiency.
• People who have taken St John's Wort or certain other herbal supplements or foods that strongly affect a liver enzyme called CYP3A4 within the past 14 days.
• People who have received a blood transfusion within the past 7 days.
• People with poor liver or kidney function.
• People whose liver function is getting worse in a way that may make them ineligible under the trial's requirements.
• People with other signs of poor liver function.
• People with inadequate bone marrow function or poor organ function.
• People with a prior history of long-lasting severe reduction in all blood cell types (lasting more than 4 weeks) caused by a previous treatment rather than by the cancer itself.
• People with heart problems or other significant heart conditions likely to affect their ability to participate.
• People with certain heart rhythm measurements outside specified limits on a resting heart tracing (ECG) — specific values differ for males and females (confirm with trial site).
• People with significant abnormalities in heart rhythm or electrical conduction on a resting ECG (controlled atrial fibrillation is permitted).
• People who, in the treating doctor's opinion, have factors that increase the risk of a certain type of heart rhythm problem.
• People who, in the treating doctor's opinion, are unlikely to follow the study's procedures and requirements.
• People with a history of a condition where red blood cells are destroyed or bone marrow stops working (haemolytic anaemia or marrow aplasia).
• People who have received a live-virus vaccine within the past 28 days (standard flu or COVID vaccines without live virus are permitted).
• People with a history of severe lung inflammation (grade 3 or 4 pneumonitis or interstitial lung disease) within the past 5 years, or other significant lung conditions likely to affect participation.

For parts involving immunotherapy combination (Module 2 all parts and certain Module 1 crossover participants):

• People who stopped a prior immunotherapy checkpoint inhibitor treatment because of side effects from that treatment.
• People who have a known allergy or sensitivity to cemiplimab (an immunotherapy drug used in the trial) or who cannot take it based on approved local medical guidelines.
• People who have experienced certain immune-related side effects of grade 2 or above during this study (applies to crossover participants only).

For the colorectal cancer group (Module 2, Part D):

• People with colorectal cancer of the specified molecular type whose disease is limited only to the lining of the abdomen (peritoneal disease only).
• People with colorectal cancer of the specified molecular type who have previously received immunotherapy treatment.

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