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 a specific type of kidney cancer called clear cell renal cell carcinoma (ccRCC), confirmed by a tissue or cell sample (biopsy).
• People who have between 1 and 5 measurable areas where cancer has spread (metastases), confirmed by imaging taken within the past 45 days.
• People who have small, untreated brain metastases (less than 2cm) with minimal symptoms, or people who have had brain metastases treated previously (up to three), with no signs of the cancer growing back on a follow-up brain scan.
• People whose cancer specialist (radiation oncologist) has confirmed that all cancer sites can be treated with a targeted form of radiation called stereotactic body radiation therapy (SBRT).
• People who have or have had another type of cancer, as long as that cancer or its treatment is unlikely to interfere with this trial's assessments (confirm with trial site).
• People with a history of heart disease or prior treatment with heart-affecting medicines, provided a heart function assessment places them in a category described as Class 2B or better under a standard medical classification system (confirm with trial site).
• People who can understand the trial and are willing to sign a consent form.
• People who are reasonably physically active and able to carry out daily activities, as measured by a standard health scale (ECOG Performance Status 0–2; confirm with trial site).
• People whose organs (such as kidneys and liver) and bone marrow are functioning adequately as defined by the trial protocol.
• People living with HIV who are on effective treatment and have had an undetectable level of the virus within the past 6 months.
• People with a history of hepatitis B (HBV) who are on suppressive treatment and have an undetectable viral load.
• People currently being treated for hepatitis C (HCV) who have an undetectable viral load.
• People who have previously had radiation therapy to some sites, as long as there is no sign of cancer returning at those sites (those previously treated sites will not be treated again in this trial).
• People who have previously had surgery to remove a kidney or to remove metastases.

Who may not be able to join:

• People with untreated brain metastases larger than 2cm that cannot be surgically removed and that are causing significant neurological problems.
• People whose kidney cancer is not the clear cell type (variant histology).
• People whose cancer has spread into the digestive tract (such as the oesophagus, stomach, intestines, colon, or rectum).
• People who have more than 2 areas of cancer spread in the liver, or liver metastases that are blocking the bile ducts and causing jaundice.
• People who have previously received any combination drug treatment for metastatic kidney cancer, including immune checkpoint inhibitors or targeted therapies called tyrosine kinase inhibitors.
• People who have received immune therapies (such as checkpoint inhibitors or cancer vaccines) within the past 12 months (note: people previously treated with a drug called pembrolizumab for non-metastatic kidney cancer may be eligible if it has been more than 12 months since their last dose and their cancer has not progressed in that time).
• People with an active autoimmune disease that requires ongoing treatment, including daily steroid medicines above a certain dose or other medicines that suppress the immune system (inhaled steroids and low-dose adrenal replacement steroids may be permitted; confirm with trial site).
• People who have already received more than one prior drug treatment for metastatic disease (confirm with trial site, as the wording of this criterion is complex).
• People with active tuberculosis.
• People with uncontrolled high blood pressure (systolic above 190 mmHg or diastolic above 110 mmHg).
• People who need major surgery within 30 days before joining the trial.
• People who have a serious non-healing wound, ulcer, or bone fracture within the 30 days before joining the trial.
• People who have had a serious arterial blood clot event (such as a heart attack or stroke) within the past 180 days.
• People with moderate or severe liver impairment.
• People with an untreated blood clot in the lungs (pulmonary embolism) or legs (deep-vein thrombosis).
• People with an unstable heart rhythm disorder within the past 180 days.
• People with a history of certain serious abdominal complications (such as a fistula, bowel perforation, abscess, bowel blockage, or stomach outlet obstruction) within the past 180 days.
• People with a history of, or currently active, inflammatory bowel disease.
• People with a history of connective tissue disease or another condition where radiation therapy is not considered safe.
• People who are pregnant or breastfeeding.
• People who are planning to conceive children during or within 6 months after the trial, and who are unwilling or unable to use effective contraception or abstain from sexual intercourse during that period.
• People with a history of a heart condition called myocarditis.
• People with certain elevated heart-related protein levels (troponin T or troponin I) in their blood at the start of the trial (confirm with trial site).
• People who have had a significant local or widespread infection requiring antibiotic treatment within the 2 weeks before starting the trial.
• People with an active infection currently requiring treatment.
• People with an ongoing or recent (within the past 2 years) autoimmune disease that required treatment with immune-suppressing medicines (some conditions such as vitiligo, resolved childhood asthma, stable thyroid conditions managed with hormone replacement, and psoriasis not needing systemic treatment are not excluded).
• People with uncontrolled HIV, hepatitis B, or hepatitis C infection, or a diagnosed immune deficiency linked to a chronic infection.
• People with a known allergy to the trial medicines or their ingredients.
• People who have received a live vaccine within 30 days before the planned start of the trial.
• Women who could become pregnant, unless permanently sterile, who do not have a negative pregnancy blood test at the screening stage.

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