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:

For Cohort A or Cohort B (Kidney Cancer groups):

• People with a confirmed diagnosis of advanced kidney cancer (renal cell carcinoma), including any type — clear cell, non-clear cell, or fully sarcomatoid forms
• For Cohort A: People who have had any number of previous cancer treatments
• For Cohort B: People who have not received any systemic (whole-body) cancer treatment for their advanced/metastatic kidney cancer
• People in Cohort B who previously received a type of immunotherapy (such as pembrolizumab) as adjuvant or neoadjuvant treatment may still be considered eligible, provided that treatment finished more than 12 months before the start of trial therapy
• Treatment-naïve patients may be placed in Cohort A if the treating doctor determines that nivolumab is not suitable, or that single-agent cabozantinib is the most appropriate option

For Cohort C (Neuroendocrine Tumour group):

• People with a well-differentiated neuroendocrine tumour (NET), grades 1–3, originating from any part of the body, whose disease has progressed on somatostatin analog treatment or who are not considered eligible for somatostatin analogs according to their treating doctor
• People whose disease has progressed within the past 12 months
• People who are currently on or have previously received somatostatin analog treatment (at a stable dose for at least 2 months), with no limit on how many previous lines of treatment they have had

For all groups:

• People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
• People whose blood pressure is controlled or can be brought under control before or during the screening process
• People aged 18 or older
• People with a general health/activity level rated 0, 1, or 2 on the ECOG scale (confirm with trial site), meaning they are able to carry out at least some daily activities
• People whose blood test results show that their bone marrow, liver, and kidneys are functioning adequately, including sufficient levels of white blood cells, platelets, haemoglobin, albumin, and appropriate levels of liver and kidney function markers (specific thresholds apply — confirm with trial site)
• People who are able to understand and willing to sign a written consent form
• People who are sexually active and able to have children must be willing to use an accepted form of contraception during the trial and for 4 months after the last dose of treatment

Who may not be able to join:

• People who have had systemic cancer treatment or radiotherapy within the past 14 days (or within five half-lives of the drug, whichever is shorter)
• People who have had radiation therapy to bone within the past 2 weeks, other radiation therapy within the past 4 weeks, or treatment with radioactive substances within the past 6 weeks — or who are still experiencing significant side effects from prior radiation
• People who have previously been treated with the drug cabozantinib
• People in Cohort B who have received any prior systemic treatment for advanced kidney cancer
• People in Cohort B who have an active, known, or suspected autoimmune disease (some mild or stable autoimmune conditions such as vitiligo, type 1 diabetes, thyroid conditions requiring only hormone replacement, or psoriasis not needing systemic treatment may still be considered — confirm with trial site)
• People in Cohort B who are currently taking corticosteroids (such as prednisone at more than 10 mg per day) or other immune-suppressing medications within 14 days of starting the study drug (inhaled or topical steroids and certain low-dose replacements may be allowed — confirm with trial site)
• People who are currently taking part in another clinical trial involving an investigational treatment
• People who have had a serious allergic reaction or hypersensitivity to a drug with a similar chemical or biological makeup to the drugs used in this trial
• People who are currently taking, or are expected to need, certain strong medications that affect the way the body processes drugs (known as strong CYP3A4 inhibitors or inducers) — topical forms of these medications may be allowed (confirm with trial site)
• People taking certain blood thinners, including warfarin, dabigatran, betrixaban, or clopidogrel — some other blood thinners such as low-dose aspirin, low molecular weight heparins (LMWH), rivaroxaban, edoxaban, or apixaban may be permitted under specific conditions (confirm with trial site)
• People with uncontrolled ongoing illness, such as an active serious infection, severe heart failure, unstable chest pain, irregular heart rhythms, or mental health or personal circumstances that would make it difficult to follow the trial requirements
• People with serious heart conditions, including severe heart failure (New York Heart Association Class 3 or 4), unstable chest pain, or serious heart rhythm problems
• People with a specific type of irregular heart rhythm measurement (QTcF greater than 500 msec) recorded within 28 days before the first dose (confirm with trial site)
• People with blood pressure that remains above 160/100 mmHg despite the best available blood pressure treatment
• People who have had a stroke, mini-stroke (TIA), heart attack, or a blood clot (such as a deep vein thrombosis or pulmonary embolism) within the past 6 months — some people with a small, stable, symptom-free blood clot being treated with approved anticoagulants may still be considered (confirm with trial site)
• People with certain serious stomach or bowel conditions, including tumour growing into the digestive tract, active peptic ulcers, inflammatory bowel disease, diverticulitis, gallbladder inflammation, pancreatitis, or bowel blockage
• People who have had an abdominal fistula (abnormal internal connection), bowel perforation, bowel obstruction, or an internal abdominal abscess within the past 6 months
• People with cavities or hollow areas forming in lung tumours, or cancer affecting the airways inside the lungs
• People whose tumours are growing into or completely surrounding major blood vessels (those involving certain liver blood vessels may still be considered — confirm with trial site)

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