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 or older
• People who have been diagnosed with advanced or metastatic kidney cancer (specifically a type called clear cell renal cell carcinoma) that cannot be cured with surgery or radiation, at any risk level
• People whose cancer can be measured on scans according to standard medical criteria (note: certain liver lesions that have been previously treated, tumors in previously irradiated areas, or disease only detectable by physical exam do not count as measurable)
• People who are reasonably active and able to care for themselves, including those with some limitations (confirmed by a standard doctor-rated scale called ECOG, scores 0, 1, or 2)
• People whose recent blood test results (taken within 15 days before joining) show that their blood counts, liver function, kidney function, and blood clotting levels all fall within the ranges required by the trial
• People who test negative for pregnancy within 8 days before joining (applies to those who could become pregnant)
• People who are willing to sign a consent form agreeing to participate
• People who are willing to provide blood samples for research purposes as required by the trial
• People who are willing to provide tissue samples for research purposes as required by the trial
• People who are willing to return to Mayo Clinic for follow-up visits during the active monitoring period of the study

Who may not be able to join:

• People who are pregnant or currently breastfeeding
• People who could become pregnant or father a child and are not willing to use adequate contraception during the trial (because the effects of the study drug on a developing baby are unknown)
• People who have already received any treatment for advanced or metastatic kidney cancer (Stage IV)
• People who have a history of blood clots blocking the main portal vein (a major blood vessel in the abdomen) beyond certain limited branches — lower-level clots related to the kidney tumour may still be eligible (confirm with trial site)
• People who have received a live vaccine within 30 days before joining — injected flu vaccines are generally allowed, but nasal spray flu vaccines are not
• People who have had surgery within 3 weeks, chemotherapy within 2 weeks, or radiation therapy within 2 weeks before joining
• People who have had any prior treatment for advanced or metastatic kidney cancer, including immunotherapy given after surgery if the cancer came back during or within 6 months of that treatment
• People with significant heart problems, including severe heart failure (Class III or IV), known or symptomatic coronary artery disease, or certain heart rhythm problems such as atrial fibrillation
• People with other serious ongoing illnesses or conditions that, in the trial doctor's judgement, would make participation unsafe or affect the ability to assess the treatment properly
• People with uncontrolled ongoing conditions such as active infection, unstable chest pain, uncontrolled heart rhythm problems, heart failure with symptoms, or a need for constant oxygen therapy
• People with a weakened immune system who are taking steroid medications at doses above 10mg per day of prednisone (or equivalent) within one week before joining — inhaled steroids for lung conditions are allowed
• People with a known history of active or organ-threatening autoimmune diseases (such as lupus, inflammatory bowel disease, or autoimmune hepatitis) that could flare with immunotherapy — people with well-controlled or inactive autoimmune conditions may still be eligible (confirm with trial site)
• People with a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have lung inflammation or certain lung diseases that could interfere with detecting treatment side effects
• People with a current serious infection (rated Grade 3 or higher on a standard medical scale) within 2 weeks before joining
• People with acute (sudden/new) hepatitis B or hepatitis C infection — those with long-standing, well-controlled hepatitis B or C may still be eligible (confirm with trial site)
• People who are HIV-positive and currently receiving HIV treatment
• People with a known history of active tuberculosis
• People with uncontrolled high blood pressure or uncontrolled diabetes
• People with significant lung disease, such as a condition severe enough to require hospitalisation within 3 months before joining
• People who are currently receiving other cancer treatments or other investigational therapies at the same time
• People who have another active cancer that is growing or requires treatment — exceptions include certain low-risk skin cancers, treated cervical cancer confined to its original site, low-grade prostate cancer confined to the prostate, or any cancer that has been treated with curative intent with no recurrence for 3 or more years
• People who have had a heart attack within the past 6 months, or who have heart failure requiring ongoing treatment for life-threatening heart rhythm problems

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