Phase 2 Kidney Cancer Trial, Recruiting

Written by an AI model from the 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 (confirmed by lab testing of cells or tissue) with either clear cell renal cell carcinoma (a type of kidney cancer with clear cell features) for Group 1, or papillary renal cell carcinoma (a type of kidney cancer with papillary features) for Group 2.
• People whose kidney cancer has spread or is advanced, and who have at least one tumour that can be measured on a scan, according to standard measurement guidelines.
• People in Group 1 (clear cell type) who have previously received a type of cancer treatment called checkpoint inhibitor therapy, and who have also received — or were not able to receive — a treatment that targets a pathway called VEGF.
• People in Group 2 (papillary type) who may either have never received treatment for their kidney cancer, or who have previously received systemic (whole-body) treatment.
• People aged 18 or older.
• People who are generally well enough to carry out light daily activities — based on a standard doctor-assessed fitness scale scoring 0 or 1 (confirm with trial site).
• People whose blood counts meet minimum levels at the screening stage: enough white blood cells (neutrophils), haemoglobin (with no blood transfusion in the past 2 weeks), and platelets.
• People whose kidney and liver function blood test results fall within acceptable ranges at screening (confirm specific values with trial site).
• People who have tested positive for hepatitis C virus (HCV) but whose virus levels are undetectable on testing.
• People who are HIV positive, provided they have been on stable HIV treatment for at least 4 weeks before the trial starts, have had no serious HIV-related infections or a condition called Castleman's disease in the past 12 months, have undetectable virus levels, and have an adequate immune cell count (confirm details with trial site).
• People who have cancer that has spread to the brain, provided it has been at least 4 weeks since brain surgery or radiotherapy and there are no signs of the brain cancer growing or causing symptoms.
• Women who could become pregnant must agree to use one highly effective form of contraception (such as hormonal contraception, a contraceptive device, or surgical sterilisation) before joining, throughout the trial, and for 6 months after the last dose, and must not donate eggs during this time.
• Men with female partners who could become pregnant or who are currently pregnant must use a condom (even after vasectomy) during treatment and for at least 6 months after the last dose, and must not donate sperm during this time.
• People who are currently breastfeeding must be willing to stop breastfeeding from the time of joining the trial until 6 months after treatment ends.
• People who are able to understand and willing to sign a written consent form.

Who may not be able to join:

• People who have received chemotherapy, hormonal therapy, immunotherapy, experimental treatment, or radiation therapy for kidney cancer within 4 weeks (or 5 half-lives of the drug, whichever is shorter) before the trial starts.
• People who have already received more than four rounds of systemic (whole-body) treatment for advanced kidney cancer.
• People who have a wound that has not healed properly after a previous surgery (wound dehiscence).
• People with active inflammatory bowel disease, ongoing diarrhoea, problems absorbing food in the gut, or other conditions that could affect how the body absorbs one of the trial medications.
• People who have had a serious allergic reaction to medications that are chemically similar to the drugs used in this trial.
• People who previously experienced a severe (grade 3 or higher) immune-related side effect from checkpoint inhibitor therapy — though people who had severe hormone-related side effects from that treatment may still be considered eligible (confirm with trial site).
• People with an active autoimmune disease — though people with certain milder conditions such as type 1 diabetes, eczema, vitiligo, hair loss, psoriasis, thyroid conditions, or adrenal insufficiency managed on low-dose steroids may still be considered (confirm with trial site).
• People taking high-dose steroid medications or certain immune-suppressing drugs (such as cyclophosphamide, methotrexate, or similar medications) — though people using steroids applied to the skin, inhaled, or used in the eyes or nose may still be considered (confirm with trial site).
• People who have previously had a bone marrow transplant or solid organ transplant (such as a kidney or liver transplant).
• People with a current or past hepatitis B infection.
• People with a history of a lung condition called interstitial lung disease, non-infectious inflammation of the lungs, or who have untreated active or latent tuberculosis (TB).
• People who are currently taking certain medications that strongly affect how a liver enzyme called CYP3A processes drugs, within 21 days (or 5 half-lives, whichever is shorter) before the trial starts (confirm the specific medications with the trial site or check the FDA reference list).
• People who have taken any herbal supplements within 14 days before the trial starts.
• People who have had a different type of cancer (not kidney cancer) within the past 2 years — though some exceptions apply for certain early-stage or low-risk cancers that do not currently require treatment (confirm with trial site).
• People who are currently pregnant (confirmed by a blood test at screening).
• People with an ongoing or uncontrolled illness that could affect their ability to follow the trial requirements, as assessed by the trial doctor.

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