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:

• People aged 18 years or older
• For the Phase Ib part: People who have been diagnosed (by tissue or cell sample) with a locally advanced or metastatic solid tumour (not liver cancer or thyroid cancer) that has progressed after standard treatment, or where standard treatment is not tolerated or not available
• For Phase II Group 1: People diagnosed with non-small cell lung cancer, kidney cancer, or liver cancer whose cancer stopped responding to a previous PD-(L)1 inhibitor treatment, and who have had no more than 2 prior lines of systemic treatment
• For Phase II Group 2: People with kidney cancer that cannot be surgically removed, is locally advanced, has spread to other parts of the body, or has come back after prior treatment
• Tumour tissue must be provided — either from archived stored samples or a fresh biopsy; if a biopsy is not available, samples taken before any prior chemotherapy may be accepted
• For Phase Ib and Phase II Group 1: People with a functional ability score rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work); for Phase II Group 2: people scoring 70 or above on a separate standard physical ability scale (confirm with trial site)
• People expected to live for at least 12 weeks
• People who have at least one tumour that can be measured using standard imaging criteria
• People with adequate organ function as assessed by the trial team
• People who are willing and able to give signed informed consent

Who may not be able to join:

• People who have received any anti-cancer treatment within 4 weeks before starting the study drug
• People who still have significant side effects (above a mild level) from previous cancer treatment at the time of starting the study drug
• People whose high blood pressure has not been adequately controlled with blood pressure medication
• People who have previously been treated with a drug called Lenvatinib, or who have taken part in a clinical trial of a similar drug (applies to all parts of the trial)
• For Phase II Group 1: People who could not tolerate a PD-(L)1 inhibitor treatment previously, or who have a history of serious digestive conditions that could affect how the body absorbs oral medication
• People with serious heart or blood vessel conditions that are not under control
• People with an active autoimmune disease, or a known or suspected history of autoimmune disease
• People who have taken more than 10 mg per day of prednisone (or an equivalent steroid medication) within the 14 days before starting the study drug, or who require ongoing steroid treatment at that level
• People who have received a live vaccine within 28 days before starting the study drug, or who are scheduled to receive one during the trial
• People with known or suspected lung inflammation (interstitial pneumonia)
• People with a serious active infection requiring antibiotic, antifungal, or antiviral treatment at the time of screening, including active tuberculosis; or people with a known history of HIV or AIDS
• People with active hepatitis B or hepatitis C infection
• People with a known history of severe gastrointestinal bleeding, active coughing up of blood, or other serious bleeding within the 6 months before starting the study drug
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires repeated drainage
• People with active or symptomatic cancer that has spread to the brain or the lining of the brain
• People who have had another primary cancer within the past 5 years
• People with a known allergy or serious reaction to any ingredient in the study drugs
• People who are pregnant or breastfeeding
• People with imaging showing cancer growing into or around major blood vessels may or may not be eligible depending on the treating doctor's assessment of risk (confirm with trial site)

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