Early Phase 1 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 or older who have been diagnosed with kidney cancer (renal cell carcinoma), confirmed through a tissue sample taken during the study's screening process.
• People whose kidney cancer is at a certain stage (cT2 to cT4), based on CT or MRI scans taken during screening, and whose cancer can be surgically removed — including some people with nearby lymph node involvement, if the surgeon considers the disease removable.
• People whose general health and ability to carry out daily activities meets a certain standard, assessed within 7 days before the first treatment dose (confirm with trial site).
• People whose blood pressure is adequately controlled (at or below 150/90 mmHg), with no changes to blood pressure medications in the week before joining the trial.
• People whose heart, liver, kidney, and blood functions meet the required levels (confirm with trial site for specific values).
• Male participants who agree to either abstain from heterosexual intercourse or use appropriate contraception during treatment and for at least 7 days after the last dose of one of the study drugs (lenvatinib). Males whose partner is pregnant or breastfeeding must abstain from penile-vaginal intercourse or use a condom throughout.
• Female participants who are not pregnant or breastfeeding, and who are either not capable of becoming pregnant, or who agree to use a highly effective form of contraception or remain abstinent during treatment and for at least 120 days after the last dose of one study drug (pembrolizumab) or 30 days after the last dose of the other (lenvatinib), whichever is later.
• People (or their legal representative) who are willing and able to provide written consent to participate.

Who may not be able to join:

• Women capable of becoming pregnant who have a positive pregnancy test shortly before the first treatment dose.
• People who have previously received certain types of immunotherapy drugs that work on specific immune system pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or similar agents targeting CTLA-4, OX-40, or CD137).
• People who have had any systemic cancer treatment, including experimental treatments, within 4 weeks before joining the trial.
• People who have had major surgery within 3 weeks before the first treatment dose.
• People whose scans show that the cancer has spread to distant parts of the body (distant metastases), with the exception of certain nearby lymph node or adrenal gland involvement that a surgeon considers removable.
• People whose treating doctor considers urgent surgery necessary.
• People with a pre-existing severe abnormal connection or opening between organs or body surfaces (a fistula rated Grade 3 or higher) in the digestive system or elsewhere.
• People whose heart pumping function is at or below 40%, as measured by specific heart tests.
• People with high levels of protein in their urine, unless a more detailed urine test confirms the level is within an acceptable range.
• People with a significantly prolonged electrical interval in the heart (QTcF greater than 480 milliseconds), as measured by an ECG.
• People who have had serious heart or blood vessel problems within the past 12 months, such as severe heart failure, unstable chest pain, heart attack, stroke, or certain abnormal heart rhythms. Medically controlled heart rhythm problems may be acceptable (confirm with trial site).
• People who have a digestive condition that could affect how the body absorbs one of the study drugs (lenvatinib), as determined by the investigator.
• People who have coughed up significant amounts of bright red blood within 3 weeks before the first treatment dose.
• People who have received a live or live-weakened vaccine within 30 days before the first treatment dose. Non-live (killed) vaccines are permitted.
• People currently participating in, or who have recently participated in, another study involving an experimental drug or device within 4 weeks before the first treatment dose.
• People with an immune system deficiency, or who are currently taking high-dose steroid medications or other immune-suppressing treatments within 7 days before the first treatment dose.
• People who have another cancer that is currently active or has required treatment within the past 3 years. Some exceptions apply for certain skin cancers, non-invasive cancers, low- or intermediate-risk prostate cancer, or cancers treated with curative intent (confirm with trial site).
• People who have had a severe allergic reaction (Grade 3 or higher) to either of the study drugs or their ingredients.
• People with an active autoimmune disease that has needed systemic medical treatment within the past 2 years. Hormone or replacement therapies (such as thyroid hormone or insulin) are generally not considered a reason for exclusion (confirm with trial site).
• People with a history of, or current, non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment.
• People with an active infection currently requiring treatment with systemic medications.
• People with a known history of HIV infection.
• People with known active Hepatitis B or Hepatitis C infection.
• People with any other condition, treatment history, or lab result that the investigating doctor believes could interfere with the study or would not be in the person's best interest.
• People with known psychiatric conditions or substance use problems that would make it difficult to follow the study requirements.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period (from screening through 120 days after the last treatment dose).
• People who have previously received an organ or tissue transplant from another person.

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