Phase 2 Oesophageal 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 (confirmed by lab testing of tissue or cells) with advanced melanoma, kidney cancer (renal cell carcinoma), non-small cell lung cancer, liver cancer (hepatocellular carcinoma, classified as Child-Pugh Class A only), certain bowel/solid cancers with a specific genetic marker (MSI-High), bladder/urinary tract cancer, stomach or gastro-esophageal junction cancer, or head and neck cancer — where standard treatment for their stage of disease would normally involve pembrolizumab or nivolumab alone
• People whose tumour is in a location where a tissue sample (biopsy) can be safely taken before and after treatment — a fine needle sample (FNA) is not sufficient; a core or surgical biopsy is required
• People aged 18 or older
• People who have at least one area of measurable disease based on standard imaging criteria (RECIST 1.1)
• People with a general health and activity level rated 0, 1, or 2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People whose blood test results show normal organ and bone marrow function, including: white blood cell count (neutrophils) of at least 1,500/mcL, platelets of at least 100,000/mcL, bilirubin within the normal range for the testing lab, liver enzyme levels (AST/ALT) no more than 2.5 times the normal range, and kidney function (creatinine clearance) of at least 40 mL/min/1.73m²
• Women who could become pregnant must have a negative pregnancy test (urine or blood) within 7 days before the first dose of the study medication
• Women who could become pregnant must be willing to use at least one form of birth control, or abstain from heterosexual activity, during the study and for 120 days after the last dose
• Men must be willing to use adequate contraception from the first dose through to 120 days after the last dose
• People who are able to understand the study and are willing to sign a written consent form
• People who have had brain metastases in the past may be eligible, provided there is no sign of active (growing or causing symptoms) brain disease on a current MRI or CT scan
• People with type 2 diabetes who do not currently require prescription medication for diabetes, and who have not taken metformin, insulin, sulfonylureas, or thiazolidinediones in the 60 days before starting the study

Who may not be able to join:

• People who have previously been treated with anti-PD-1 or anti-PD-L1 immunotherapy drugs (such as pembrolizumab or nivolumab)
• People with type 1 diabetes, or anyone who has taken metformin, insulin, sulfonylureas, or thiazolidinediones for any reason within 60 days before starting the study
• Women who are pregnant or breastfeeding
• People with an active autoimmune disease that has required systemic (whole-body) treatment within the past 3 months, or a history of a severe autoimmune condition, or a condition requiring ongoing use of steroids or immune-suppressing medications — although some autoimmune conditions may be exceptions (confirm with trial site)
• People with a history of uncontrolled heart disease, including uncontrolled high blood pressure, unstable angina, or a heart attack within the past 6 months
• People with significant heart failure symptoms, or heart failure classified as New York Heart Association Class III or IV (confirm with trial site)
• People with a psychiatric illness or other personal or social circumstances that may make it difficult to follow the study requirements
• People with a history of lung inflammation (non-infectious pneumonitis) that required steroid treatment, evidence of chronic lung scarring (interstitial lung disease), or currently active non-infectious lung inflammation
• People who have taken an unapproved or experimental drug within 14 days before the first day of study treatment
• People who have had another cancer within the past 2 years, with the exception of certain treated skin cancers (basal cell or squamous cell), treated cervical cancer, or treated prostate cancer
• People with any other medical condition, treatment, or lab result that the treating doctor believes could affect the study results or make participation unsafe
• People with a known history of HIV infection
• People with a known allergy or sensitivity to metformin, rosiglitazone, pembrolizumab, or nivolumab
• People who are unable to swallow pills or take them through a feeding tube
• People with a history of acidosis of any type, or who regularly drink five or more alcoholic drinks per day
• People who are currently being treated with rifampin or gemfibrozil for another medical condition

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