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 been diagnosed with metastatic or advanced Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma, confirmed by a specialist pathology review.
• People who are willing and able to provide written consent to participate (or have a legal representative do so on their behalf).
• People whose cancer can be measured on scans according to standard criteria (called RECIST 1.1), including in some cases areas that have previously been treated with radiation if the cancer has grown there.
• People who are able to provide a tumour tissue sample — either stored tissue from a previous biopsy or a new biopsy — that has not previously been irradiated (fresh samples are preferred).
• People whose general health and ability to carry out daily activities meets a standard medical rating of 0 or 1 (meaning fully active or able to do light activity), assessed within 7 days before starting treatment.
• People whose liver, kidney, blood, and other organ functions meet the levels required by the trial, confirmed by blood tests taken within 10 days before starting treatment.
• People who have hepatitis B (HBV) may be eligible if they have been on antiviral treatment for at least 4 weeks and have an undetectable level of the virus before joining the trial (confirm with trial site).
• People with a history of hepatitis C (HCV) may be eligible if the virus is undetectable at the screening stage and antiviral treatment was completed at least 4 weeks before joining (confirm with trial site).
• People living with HIV may be eligible if their HIV is well controlled on stable treatment, their immune cell count and viral load meet specific thresholds, and their HIV medications do not interact with certain other drugs used in the trial (confirm with trial site).

Who may not be able to join:

• People who have previously been treated with certain types of immunotherapy drugs that target the immune system pathways known as PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137.
• People who have received any systemic cancer treatment, including experimental treatments, within 2 weeks before being assigned to a treatment group in the trial.
• People who have had radiotherapy within 2 weeks before starting the trial, or who still have side effects from radiation that require steroid medication (limited exceptions may apply for short-course palliative radiotherapy — confirm with trial site).
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of trial treatment.
• People who have used another experimental drug or medical device within 4 weeks before starting the trial.
• People who have been diagnosed with an immune system deficiency, or who are currently taking steroid medication at doses above 10 mg of prednisone per day (or equivalent), or any other medication that suppresses the immune system, within 7 days before the first dose.
• People who have another cancer that is currently growing or has required active treatment within the past 2 years (some low-risk skin cancers and early-stage prostate cancer may be exceptions — confirm with trial site).
• People with active, spreading cancer in the brain or the lining of the brain. People with previously treated brain metastases may be considered if the cancer has been stable for at least 4 weeks and they have not needed steroid treatment for at least 14 days (confirm with trial site).
• People who have had a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.
• People with an active autoimmune disease that has required systemic medical treatment within the past 2 years (hormone replacement therapies such as thyroid medication or insulin are generally not excluded — confirm with trial site).
• People who have a history of, or currently have, a lung inflammation condition (pneumonitis or interstitial lung disease) that required steroid treatment.
• People who currently have an active infection that requires systemic treatment (such as antibiotics or antifungals given into a vein or by mouth).
• People who have not fully recovered from a major surgical procedure or who have ongoing complications from surgery.
• People who have a condition, treatment history, or other circumstance that the treating doctor believes could interfere with the trial results or would not be in the person's best interest.
• People with known psychiatric conditions or substance use disorders that would make it difficult to participate fully in the trial.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period and for 120 days after the last dose of treatment.
• People who have previously received a transplant of donor tissue or a solid organ.

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