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 are willing and able to sign a written consent form agreeing to take part in the study
• People who are 18 years of age or older
• People who have been diagnosed with a type of kidney cancer called renal cell carcinoma (RCC) that includes a "clear cell" component
• People whose kidney cancer has spread to other parts of the body (Stage IV metastatic disease)
• People who have not received any previous systemic (whole-body) drug treatment for their kidney cancer, including no prior treatments given before or after surgery
• People whose general health and ability to function meets a minimum level, as measured by a standard medical scoring tool (Karnofsky performance status of 70% or higher)
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST 1.1); a tumour in a previously treated radiation area may count only if it has been shown to have grown since that treatment
• People whose blood counts, kidney function, and liver function test results are within acceptable ranges when tested within 28 days before starting treatment (confirm specific values with trial site)
• Women who are not breastfeeding during treatment and for up to five months after the last dose
• Women who could potentially become pregnant must have a negative pregnancy test within 24 to 72 hours before starting treatment
• Women who could potentially become pregnant must agree to use acceptable contraception from the time of signing consent until 23 weeks after their last dose

Who may not be able to join:

• People who have had any previous systemic drug treatment for kidney cancer, including treatments given before or after surgery
• People who have had major surgery requiring general anaesthesia within 28 days before starting treatment
• People who have had radiation therapy, minor surgery, or an active infection requiring intravenous antibiotic or antifungal treatment within 14 days before starting treatment
• People who have a history of, or currently have, cancer that has spread to the brain or spinal cord (central nervous system metastases)
• People who need to take corticosteroid tablets or injections at doses above a low threshold, or other medicines that suppress the immune system, within 14 days before starting treatment (low-dose topical, inhaled, or replacement hormone forms may be permitted — confirm with trial site)
• People with an active or known autoimmune disease (some specific autoimmune conditions that are well-controlled may still be eligible — confirm with trial site)
• People with a psychiatric condition, personal circumstances, or other medical situation that the trial doctors judge would make safe participation or understanding of the trial unreasonably difficult
• People with any history of inflammation of the heart muscle (myocarditis), regardless of the cause
• People with significantly elevated levels of a heart stress marker in the blood called troponin (above twice the normal upper limit); people with mildly elevated troponin may be considered after further heart assessment (confirm with trial site)
• People who have received a live or weakened (attenuated) vaccine within 30 days before starting treatment

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