Phase 2 Kidney 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:

• Adults aged 18 or older at the time of screening (or 19 or older, depending on local rules)
• People whose liver, kidneys, and other organs are functioning well enough, as defined by the trial protocol
• People whose cancer can be measured on scans, according to a standard set of measurement rules called RECIST v1.1
• People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard health scale used by doctors (called the ECOG scale)
• People whose side effects from any previous cancer treatments (such as chemotherapy, radiotherapy, immunotherapy, or surgery) have mostly cleared up, except for hair loss or mild nerve-related symptoms in the hands or feet
• People living with HIV, provided they are on HIV medication and their HIV is well controlled, as defined by the trial protocol

Who may not be able to join:

• People whose cancer has spread to the brain or the lining around the brain and spinal cord, if that spread is currently active
• People who currently have a second cancer that is active
• People with active or known Hepatitis B, or active Hepatitis C infection
• People with active tuberculosis (TB) or a known history of active TB
• People with an active or uncontrolled infection, or who had a serious infection within 4 weeks before starting the study treatment
• People with a history of chronic liver disease or liver scarring (cirrhosis), unless their cancer has spread to the liver
• People with an autoimmune disease that has needed systemic (whole-body) treatment at any point in the past 2 years
• People who have previously received certain immunotherapy treatments that work in a similar way to the study drug GI-101 (confirm with trial site)
• People with an immune system disorder, or who have been taking steroid tablets or other immune-suppressing medicines within 2 weeks before the first day of treatment
• People who have received any systemic cancer treatment, including experimental treatments, within 4 weeks before starting study treatment
• People who have had radiotherapy within 2 weeks before starting study treatment, with the exception of limited palliative radiotherapy aimed at relieving symptoms
• People who have received a live vaccine within 4 weeks before the first day of treatment
• People with a known allergy to any ingredient in the study drugs GI-101, GI-101A, pembrolizumab, or lenvatinib

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