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 have been diagnosed (confirmed by laboratory testing) with advanced or metastatic cancer in one of these specific types: liver cancer (hepatocellular carcinoma), kidney cancer (renal cell carcinoma), breast cancer, ovarian or fallopian tube cancer, or endometrial or primary peritoneal cancer — and the cancer involves the abdomen or chest area, and either standard treatments are not tolerable or the cancer has continued to grow despite standard treatment.
• People aged 18 or older.
• People who are largely able to carry out daily activities with little or no restriction, as measured by a standard medical scale (ECOG performance status 0–1) (confirm with trial site).
• People with a life expectancy of more than 3 months.
• People whose bone marrow is producing enough blood cells, based on specific blood test results falling within required ranges (confirm with trial site for exact values).
• People whose liver is functioning adequately, based on specific blood test results (confirm with trial site), including people with a condition called Gilbert's syndrome or those with liver spread of their cancer, who may still be eligible under adjusted thresholds.
• People with liver cancer (HCC specifically) who also have well-preserved liver function (Child-Pugh status A), no significant fluid build-up in the abdomen requiring treatment, and no history of bleeding from the oesophagus or stomach, poor wound healing, bowel perforation, or abnormal connections between organs.
• People whose kidneys are functioning adequately, based on a calculation of kidney filtration rate (confirm with trial site for exact method and threshold).
• People whose cancer can be measured or evaluated on imaging scans, using standard medical criteria.
• Women who could potentially become pregnant must agree to use reliable contraception (hormonal, barrier methods, or abstinence) throughout the study, and must inform their treating doctor immediately if they become or suspect they are pregnant during the study.
• Male participants must agree to use effective contraception or abstinence while on the study.
• People who are able to operate the tumour treating fields (TTF) device on their own or with the help of a caregiver.

Who may not be able to join:

• People who have received anti-cancer therapy or radiation therapy within the 2 weeks before starting the trial treatment, or who have had major surgery within 4 weeks before starting (note: palliative radiation therapy is permitted; people already taking cabozantinib or the other study drugs as standard care may be able to transition to the trial within the first 2–3 weeks — confirm with trial site).
• People who have not yet recovered from side effects of previous cancer treatments (side effects must have resolved to a mild or absent level).
• People with active cancer that has spread to the brain or the lining of the brain and spinal cord; people with previously treated brain metastases may be considered if their condition has been stable on brain imaging for at least 4 weeks and they have been off steroid medications for at least 2 weeks.
• People with certain uncontrolled heart conditions, including high blood pressure above 160/100 despite treatment, uncontrolled chest pain (angina), abnormal heart rhythms, heart failure (Class II or above), cardiomyopathy, uncontrolled irregular heart rhythm (atrial fibrillation) with a heart rate above 100 beats per minute, or a heart attack or severe chest pain requiring nitrates more than once a week within the past 6 months.
• People with serious uncontrolled medical conditions that could interfere with participation, such as uncontrolled diabetes, active severe infection requiring treatment, severe malnutrition, or severe chronic liver or kidney disease.
• People with another current cancer, unless: it was fully treated at least 2 years before enrolment with no evidence of disease remaining, or the Principal Investigator agrees it is clinically stable and does not require active treatment with very low risk of interfering with the trial, or the Principal Investigator agrees the risk is very low. Adequately treated skin cancers (basal cell or squamous cell) or carcinoma in situ are permitted.
• People who are pregnant or breastfeeding.
• People with a known allergy or medical reason preventing use of the TTF (tumour treating fields) device.
• People who have an implanted pacemaker, defibrillator, or other implanted electrical medical device.
• People with a known allergy or sensitivity to cabozantinib, nab-paclitaxel, pembrolizumab, medical adhesives, or hydrogel, or people who previously stopped taking cabozantinib because of unacceptable side effects.
• People whose doctor determines that participating in the trial would not be safe or appropriate for any other reason.
• People who are unwilling or unable to follow the study procedures or cooperate with the research team.

For people in the cabozantinib group only:

• People who have coughed up or vomited more than half a teaspoon of red blood, or shown other signs of lung bleeding, within the 3 months before starting treatment.
• People who have hollow (cavitating) lung lesions, or a lung lesion pressing against or surrounding a major blood vessel.
• People who have taken bone-strengthening medications (used to prevent bone loss) within 4 weeks before starting treatment.
• People whose blood clotting test results are above 1.3 times the normal upper limit (confirm with trial site).
• People whose heart electrical reading (QTcF interval) is above 450 ms for men or above 470 ms for women.
• People who need full therapeutic doses of blood-thinning medications such as warfarin, heparin, or similar drugs (note: low-dose aspirin of 81 mg/day or less, low-dose warfarin of 1 mg/day or less, and preventive low molecular weight heparin are permitted).
• People whose tumour is surrounding or encasing a major artery or the bowel.
• People who are unable to swallow capsules.
• People with a known allergy or medical reason preventing use of cabozantinib specifically (in addition to the general allergy criterion above).

For people in the group receiving the immunotherapy drug (atezolizumab/pembrolizumab-containing cohort) only:

• People who previously received certain immunotherapy drugs (anti-PD-1 or anti-PD-L1) may still be considered, but only under specific conditions regarding how recently those treatments were used, what side effects occurred, and whether those side effects have sufficiently resolved — confirm all details with the trial site.
• People who experienced a prior immune-related lung inflammation (pneumonitis) of Grade 2 or higher from immunotherapy are not eligible for this group.
• People with active HIV infection, or active Hepatitis B or C infection, or any active infection currently requiring antibiotic treatment.
• People who have received a live vaccine within 30 days before the first dose.
• People with active diverticulitis, an abscess inside the abdomen, a bowel blockage, cancer spread throughout the abdominal lining, or other conditions that raise the risk of bowel perforation.
• People with serious active autoimmune diseases, including inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), rheumatoid arthritis, scleroderma, lupus, or autoimmune vasculitis.
• People with a history of, or current, immune system deficiency disease, or who have had prior treatments that significantly weakened their immune system (at the treating doctor's discretion).

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