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 who have given written consent to participate
• People who have been diagnosed with kidney cancer (any subtype) confirmed by tissue testing, at a stage where the cancer has grown into nearby large blood vessels (specifically a large vein called the inferior vena cava) at certain levels of severity, with or without spread to a limited number of other areas
• People whose cancer and blood vessel involvement may or may not be removable by surgery at the time of joining the trial
• People whose cancer can be measured on scans according to standard criteria (called RECIST 1.1)
• People who are generally well enough to carry out light activity and care for themselves (as assessed by a standard health scale called ECOG, scored 0 or 1), tested within 14 days before starting treatment
• People with a history of Hepatitis B who have been on antiviral treatment for at least 4 weeks and have no detectable virus in their blood before joining
• People with a history of Hepatitis C who have completed curative antiviral treatment at least 4 weeks before joining and have no detectable virus in their blood
• People living with HIV, provided their HIV is well controlled on stable treatment (with a CD4+ immune cell count of 350 or above, undetectable HIV levels for at least 12 weeks, no serious HIV-related infections in the past 12 months, and no HIV medications that interact with the study drugs)
• People whose blood, liver, kidney, and other organ function test results fall within acceptable ranges, tested within 14 days before starting treatment
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use reliable contraception during treatment and for at least 30 days after the last dose
• Men who agree to use contraception during the treatment period and for at least 90 days after the last dose, and agree not to donate sperm during that time
• People with a heart pumping function (LVEF) of 50% or higher
• People with a heart pumping function (LVEF) between 40% and 49%, provided they do not have moderate to severe heart failure symptoms (confirm with trial site)

Who may not be able to join:

• Women of childbearing potential who test positive for pregnancy within 72 hours before being assigned to the trial
• People who have previously received certain types of immunotherapy treatments that work on the immune system's checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar drugs)
• People who have previously received any systemic anti-cancer treatment, including experimental therapies, before joining
• People who have had radiotherapy within 2 weeks before starting the study treatment, or who still have side effects from radiation, or who needed steroids because of radiation-related lung inflammation (a shorter 1-week gap may apply in certain limited cases — confirm with trial site)
• People who have received a live vaccine within 30 days before the first dose (examples include measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, and typhoid vaccines; certain flu vaccines given as a nasal spray are also not permitted; injected flu vaccines and approved non-live COVID-19 vaccines are generally allowed)
• People who have taken part in another experimental drug or device study within 4 weeks before the first dose (with one specific imaging study as an exception — confirm with trial site)
• People who have an immune system disorder, or who are currently taking high-dose steroid medication or other immune-suppressing drugs within 7 days before the first dose
• People who have another active cancer that has been growing or needed treatment within the past year (some skin cancers and certain early-stage cancers that have been successfully treated are exceptions — confirm with trial site)
• People with active cancer spread to the brain or the lining around the brain, unless previous brain metastases have been treated, are stable on scans for at least 4 weeks, and have not required steroid treatment for at least 14 days
• People whose kidney cancer has spread to more than three different areas of the body
• People with a severe allergic reaction (Grade 3 or higher) to the study drugs pembrolizumab or lenvatinib, or to their ingredients
• People with an active autoimmune disease that has needed systemic medical treatment in the past 2 years (hormone or gland replacement therapies are generally not considered a reason for exclusion — confirm with trial site)
• People who have had lung inflammation (pneumonitis) that required steroid treatment in the past, or who currently have pneumonitis
• People who have an active infection that requires treatment through the bloodstream or by mouth
• People whose overall health, other conditions, or circumstances mean that participation would not be safe or appropriate, based on the treating doctor's judgement
• People with known serious psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and up to 120 days after the last dose
• People who have previously received a donor tissue or solid organ transplant
• People with a specific type of abnormal heart rhythm reading on an ECG (QTcF interval greater than 480 milliseconds)
• People with a heart pumping function (LVEF) of 39% or below
• People with a heart pumping function (LVEF) between 40% and 49% who also have significant heart failure symptoms affecting daily activities
• People with serious heart or blood vessel problems in the 12 months before starting the trial, such as severe heart failure, unstable chest pain, heart attack, stroke, or dangerous heart rhythm problems (medically controlled heart rhythm problems may be permitted — confirm with trial site)
• People with high levels of protein in their urine (specifically 2,000 mg or more in a 24-hour urine collection, if further testing is required)
• People with consistently uncontrolled high blood pressure (systolic above 140 mmHg or diastolic above 90 mmHg) despite being on optimal blood pressure medication (borderline or occasional elevations may be assessed individually by the treating doctor)
• People living with HIV who have a history of Kaposi's sarcoma or a condition called Multicentric Castleman's Disease
• People with currently active Hepatitis B infection (detectable virus or positive surface antigen in the blood)
• People with currently active Hepatitis C infection (detectable virus in the blood)

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