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 at the time of giving consent to participate
• People who are able to give their own consent, or who have a legally authorised representative who can consent on their behalf
• People who have signed and dated the official consent form approved by the review board
• People who have been diagnosed with stage IV clear cell kidney cancer or stage IV translocation-associated kidney cancer, confirmed by laboratory tissue analysis
• People for whom stored tissue samples that confirm the kidney cancer diagnosis are available — or, if no stored tissue is available, where the lead study doctor has documented confirmation (confirm with trial site)
• People who have at least one measurable area of cancer outside of the bones and brain, as defined by standard measurement guidelines (RECIST v1.1)
• People whose general health and ability to carry out daily activities meets a certain minimum level (ECOG performance score of 2 or lower)
• People who have previously received at least 2, and no more than 3, approved systemic cancer treatments — prior preventive (adjuvant) therapy is also permitted
• People whose cancer has progressed after receiving one prior treatment targeting PD-1 or PD-L1 (a type of immunotherapy), and after a prior treatment targeting a protein called VEGFR (a type of targeted therapy)
• People who have recovered from side effects of prior treatments to near-normal levels, or whose ongoing side effects are mild and stable
• People who have completed radiation therapy and fully recovered from its short-term effects, with at least 14 days passed since the end of radiation before joining the trial
• People who are able to swallow tablets or capsules
• People whose blood test results, taken within 14 days before starting treatment, show that their blood counts, liver function, kidney function, and other measures fall within the required ranges (confirm with trial site for specific values)
• Women who could become pregnant must not be pregnant or breastfeeding at the time of screening
• Women who could become pregnant and are sexually active with a male partner who has not had a vasectomy must use two forms of effective contraception from screening and for 4 months after the last dose — periodic abstinence, the rhythm method, and withdrawal are not considered acceptable methods
• All sexually active participants must use medically accepted contraception during the study and for 4 months after the last dose; male participants must agree not to donate sperm, and female participants must agree not to donate eggs, during treatment and for 4 months after the last dose

Who may not be able to join:

• People who have previously been treated with abemaciclib or cabozantinib (the study drugs)
• People who have received certain anti-cancer treatments or experimental treatments within 2 weeks before starting the study (or within 5 half-lives of the drug, whichever is shorter); for immunotherapy (checkpoint inhibitors), treatment must have stopped at least 28 days before joining
• People with brain metastases or cancer spread to the lining of the brain that are causing symptoms and require steroid medication — people with stable brain metastases who have completed treatment, recovered, and stopped steroids at least 2 weeks before starting the study may still be considered
• People diagnosed with another cancer within the past 2 years, except for certain superficial skin cancers or early-stage cancers that were treated with the intent to cure
• People who need to take medications that strongly affect how the body processes a liver enzyme called CYP3A4 (confirm with trial site for specific medications)
• People living with HIV who are not on a stable HIV treatment regimen, or who require preventive antibiotics, or whose immune cell counts or viral levels do not meet certain thresholds
• People with active hepatitis B or hepatitis C infection where the virus is detectable in blood tests
• People with an active bacterial or fungal infection that requires treatment with antibiotics or antifungals at the time of starting the study
• People with significant heart conditions, including a heart attack in the past 6 months, unstable heart rhythm, unstable chest pain, prior sudden cardiac arrest, or reduced heart pumping function below a certain level
• People with blood pressure that remains too high (above 150/90 mmHg) despite receiving appropriate blood pressure medication
• People who have experienced a significant artery-related event — such as a stroke, mini-stroke, aortic aneurysm requiring surgery, or peripheral artery blood clot — within the past 6 months
• People whose heart electrical activity (QT interval, measured by ECG) is above a certain level within 28 days before starting treatment
• People taking certain blood-thinning medications, including warfarin, dabigatran, betrixaban, or clopidogrel — some other blood-thinning medications may be permitted at low or stable doses (confirm with trial site)
• People who have had clinically significant bleeding — such as coughing or vomiting more than half a teaspoon of blood — within the past 12 weeks, or who have a known tendency to bleed
• People with certain lung lesions or cancer affecting the airways in specific ways (confirm with trial site)
• People with uncontrolled fluid build-up around the lungs, heart, or in the abdomen that requires drainage more than once a month
• People who have had major surgery within 6 weeks before starting the study, or whose surgical wounds have not fully healed
• People with cancer growing into the digestive tract, or with active conditions such as peptic ulcers, inflammatory bowel disease, diverticulitis, gallbladder inflammation, pancreatitis, or bowel obstruction
• People showing signs of bowel obstruction or who require ongoing feeding or hydration through a tube or drip
• People with a history of an abdominal fistula, bowel perforation, or abdominal abscess within the past 6 months
• People whose cancer is growing into or wrapping around a major blood vessel (with the exception of blood vessels on the same side as the original kidney tumour)
• People with cancer visibly growing into the digestive tract (such as the oesophagus, stomach, bowel, or rectum) at the time of screening
• People with a condition that prevents normal absorption of food and medications
• People with a serious wound, ulcer, or bone fracture that has not healed
• People with active COVID-19, unless they have fully recovered for at least 30 days before starting the study
• People with a known allergy or sensitivity to any ingredient in the study medications
• People who have received radiation therapy to bone metastases within 2 weeks before starting the study, or radioactive treatments within 6 weeks before starting — people with ongoing complications from prior radiation are also not eligible
• People with serious or uncontrolled medical conditions that, in the opinion of the study doctor, would make participation unsafe — examples include severe lung disease, severe breathlessness at rest, prior major removal of parts of the stomach or small bowel, Crohn's disease, ulcerative colitis, or a pre-existing condition causing ongoing moderate-to-severe diarrhoea

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