Phase 1 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 able to understand the study and are willing to sign a written consent form
• People aged 18 or older, of any gender
• People who have a confirmed diagnosis of clear cell renal cell carcinoma (a specific type of kidney cancer)
• People whose kidney cancer has spread to other parts of the body (Stage IV metastatic disease)
• For the Triplet Cohort (three-drug group): People who have not previously received any systemic (whole-body) treatment for advanced kidney cancer, or who have had prior adjuvant (preventive/post-surgery) therapy
• For the Doublet Cohort (two-drug group): People whose cancer has continued to grow or spread after receiving at least one prior treatment regimen containing a PD-1 immunotherapy drug; prior adjuvant therapy is allowed and counts as one line of treatment
• People with a performance status rated 0 or 1 on a standard scale used by doctors to measure how much a person's cancer affects their daily activities (confirm with trial site)
• People who have at least one measurable area of cancer that can be tracked on scans, as defined by standard medical guidelines; a previously treated (radiated) tumour site may count only if disease progression in that area has been documented
• People whose kidney cancer diagnosis has been confirmed through tissue testing (pathology); extra tissue samples are requested if available
• People who are willing and able to have bone and brain scans at the start of the study, and to repeat them if the initial scans show anything abnormal
• People whose blood and organ function test results meet the required levels within 28 days before starting treatment, including:
  • White blood cell count of at least 2,000 per microlitre
  • Neutrophil count (a type of white blood cell) of at least 1,000 per microlitre
  • Platelet count of at least 100,000 per microlitre
  • Haemoglobin (a measure of red blood cells) of at least 9.0 g/dL in the prior four weeks (blood transfusions are allowed to reach this level)
  • Kidney function within acceptable limits based on blood or urine tests
  • Liver function test results within acceptable limits
• Women must not be breastfeeding during the study or for up to five months after the last dose of study treatment
• Women who could become pregnant must have a negative pregnancy test within 24 hours before starting treatment
• Women who could become pregnant must agree to use an approved form of contraception from before the study starts until 23 weeks after the last dose of treatment; approved methods include hormonal contraception, an intrauterine device (IUD), tubal ligation, hysterectomy, a partner's vasectomy, implantable or injectable contraceptives, or condoms used with spermicide; complete abstinence for the full duration of the study and washout period is also acceptable (confirm with trial site)
• Men who are not infertile and who are sexually active with women who could become pregnant must agree to use an approved form of contraception from before the study starts until 31 weeks after the last dose of treatment
• People with a chronic hepatitis B infection are eligible if their virus levels are undetectable while on suppressive therapy (if that therapy is needed)
• People with a history of hepatitis C infection are eligible if they have been successfully treated and cured, or if they are currently on treatment and their virus levels are undetectable
• People who have previously been treated for cancer that has spread to the brain may be eligible if scans and clinical assessment confirm the brain metastases have been stable for at least 28 days, there are no new or growing areas of concern, and no steroid medication has been needed for at least 28 days before starting the study
• People with a history of another cancer may be eligible if that cancer or its treatment is not expected to interfere with the safety or assessment of this trial
• People with a known history of heart disease or prior treatment with heart-affecting therapies may be eligible if a doctor's assessment of heart function rates them as class 2B or better on a standard heart function scale (confirm with trial site)
• People living with HIV who are on effective treatment and have had undetectable virus levels within the past six months

Who may not be able to join:

• For the Triplet Cohort (three-drug group): People who have previously received any systemic treatment for kidney cancer, including neoadjuvant or adjuvant therapy involving an immune checkpoint inhibitor or a targeted therapy drug called a TKI
• For the Doublet Cohort (two-drug group): People who have received more than three prior lines of systemic treatment
• For the Doublet Cohort: People who have received a small molecule kinase inhibitor drug (including experimental ones) within two weeks before starting the study
• People who have had major surgery requiring general anaesthesia within 28 days before starting treatment
• People who have had radiosurgery or radiotherapy within 14 days before starting treatment
• People who have had minor surgery within 14 days before starting treatment (note: placement of a vascular access device such as a port or PICC line does not count as minor or major surgery)
• People with an active infection requiring treatment with systemic (whole-body) medication within 14 days before starting the study
• People with known or suspected significant active bleeding, including coughing up blood
• People who are unable to swallow oral (tablet or capsule) medication, or who have a poorly controlled digestive condition that could significantly affect how the body absorbs oral medication — for example, Crohn's disease, ulcerative colitis, ongoing diarrhoea (more than four loose stools per day), malabsorption conditions, or bowel obstruction
• People with active cancer spread to the brain, unless it meets the specific stability criteria described in the inclusion criteria above
• People who require ongoing treatment with corticosteroid medication at doses above 10 mg per day of prednisone (or equivalent), or other immune-suppressing medications, within 14 days before starting treatment; low-dose or locally applied steroids may be acceptable in some cases (confirm with trial site)
• People with an active, known, or suspected autoimmune disease; however, people with certain manageable conditions such as type 1 diabetes, thyroid conditions requiring only hormone replacement, or skin conditions like vitiligo or psoriasis not needing systemic treatment may still be eligible (confirm with trial site)
• People with a known psychiatric condition, personal circumstance, or other medical condition that a doctor reasonably judges would make participation too risky, or would prevent the person from understanding and consenting to the study or following the required schedule
• Women who are pregnant
• People who are currently taking part in another clinical trial involving an experimental treatment

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