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 who have been diagnosed with clear cell renal cell carcinoma (a specific type of kidney cancer) confirmed by a biopsy.
• People whose kidney cancer has been classified as intermediate-high risk, high risk, or stage M1 (spread to one isolated area that can be fully removed during surgery), based on how far the tumor has grown and its grade (aggressiveness rating).
• People who have been assessed by a urology specialist and approved as suitable for surgery to remove the kidney (nephrectomy).
• People aged 18 years or older who are willing to take part in the study.
• People who are in good general health, rated 0 or 1 on the ECOG performance scale (meaning fully active or able to carry out light activity).
• People who have had recent imaging of the chest, abdomen, and pelvis (within the past 42 days) showing no spread of cancer to distant parts of the body.
• People who have had or currently have another cancer, provided that cancer and its treatment are not expected to interfere with this study's results or safety.
• People whose blood test results meet the study's minimum requirements for blood cell counts, kidney function, liver function, and thyroid levels (confirm specific values with the trial site).
• People with a history of heart problems who have been assessed and rated Class 2B or better on the New York Heart Association scale, meaning their heart condition is considered stable enough to participate.
• Women who could become pregnant must agree to use highly effective contraception during the study and for at least 120 days after the last dose of pembrolizumab and 30 days after the last dose of belzutifan, and must have a negative pregnancy test before starting treatment.
• Men must agree to use contraception during the study and for at least 4 months after the last dose of pembrolizumab and 30 days after the last dose of belzutifan.
• People who are able to understand the study information and are willing to sign a written consent form.

Who may not be able to join:

• People whose blood oxygen level is below 92% at rest, or who need supplemental oxygen sometimes or all the time.
• People who have already received chemotherapy or radiotherapy for their kidney cancer.
• People who are currently taking part in another clinical trial with an investigational treatment.
• People who have had a previous allergic reaction to medications similar to belzutifan or pembrolizumab, or other agents used in this study.
• People who have previously been treated with certain immunotherapy drugs (anti-PD-1, PD-L1, PD-L2, or CTLA-4 therapies) or who have received certain blood-stimulating drugs within 28 days before the first dose.
• People with an immune system disorder, an active autoimmune disease, a history of lung inflammation (pneumonitis), an active infection, or a known additional cancer other than kidney cancer.
• People with a known history of HIV infection.
• People with a known history of hepatitis B or active hepatitis C infection.
• People who are pregnant or breastfeeding, as the study medications carry risks of harm to an unborn baby or infant.
• People who have another cancer that is currently active or has required treatment within the past 3 years (note: certain skin cancers or cancers treated and in full remission for at least 3 years may still be eligible — confirm with the trial site).
• People who have known cancer spread (metastases) that is not planned to be surgically removed at the time of their kidney surgery (except for certain adrenal gland metastases on the same side as the kidney).
• People with significant heart conditions, such as unstable chest pain, a heart attack within the past 6 months, or severe heart failure (Class III or IV).
• People with moderate to severe liver impairment.
• People who are unable to swallow tablets or capsules, or who have a digestive condition that affects how medication is absorbed.
• People who have previously been treated with belzutifan or any similar HIF-2α inhibitor medication.
• People who are currently taking certain medications that strongly or moderately interfere with how the body processes belzutifan (such as phenobarbital, rifampicin, carbamazepine, St John's Wort, and others), if those medications cannot be stopped for the duration of the study.
• People with an active infection currently requiring treatment with antibiotics or antiviral medications.
• People with active tuberculosis (TB).

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