Phase 2 Rare Disease 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 aged 18 or older who have cancer that has spread (metastatic disease), with at least one measurable area of cancer visible on a scan, and whose cancer falls into one of the specific cancer types listed below (confirmed by a tissue biopsy)
• People diagnosed with one of these specific cancer types: small cell or neuroendocrine carcinoma of the bladder; adenocarcinoma of the bladder or urachal adenocarcinoma or clear cell adenocarcinoma of the bladder/urethra; pure squamous cell carcinoma of the bladder; plasmacytoid urothelial carcinoma (where at least 50% of the tumour shows this type); any penile cancer; sarcomatoid renal cell carcinoma (where at least 50% of the tumour shows this type, including some unclassified kidney cancers); certain other rare bladder cancer variants including micropapillary, giant cell, lipid-rich, clear cell, nested, large cell neuroendocrine, lymphoepithelioma-like, treatment-naïve small cell prostate cancer, malignant testicular Sertoli or Leydig cell tumours, and certain kidney cancers; sarcomatoid urothelial carcinoma (at least 50% sarcomatoid); renal medullary carcinoma; genitourinary cancers (non-prostate) that have spread only to bone; renal collecting duct carcinoma; or urethral carcinoma of any tissue type
• People who have received no more than 2 prior systemic cancer treatments, or who have not yet received any cancer treatment (people with small cell carcinoma should have already received a platinum-based treatment at some stage)
• People who are physically well enough to carry out normal activity, as measured by a Karnofsky performance score of 80% or higher (confirm with trial site)
• People who are able to swallow tablets
• People whose blood counts and organ function meet specific laboratory thresholds, including adequate white blood cell counts, platelet levels, liver function, kidney function, haemoglobin, albumin, and pancreatic enzyme levels (confirm specific values with trial site)
• People living with HIV, provided they are on a stable HIV treatment regimen, have a CD4 count above 350, an undetectable viral load, and no significant drug interactions are expected
• People with certain well-controlled autoimmune or inflammatory conditions such as rheumatoid arthritis, Sjögren's syndrome, or psoriasis managed with topical treatments only, or positive autoimmune blood markers without organ damage
• People with vitiligo, or hormone-managed thyroid conditions, or those on low-dose physiologic corticosteroids
• Women of childbearing potential who have a negative pregnancy test within 7 days before joining the trial
• People whose tissue samples (H&E slides) from their original cancer diagnosis are available for review by a central pathology team

Who may not be able to join:

• People who have previously been treated with cabozantinib
• People who have previously received both a MET or VEGF inhibitor and a PD-1/PD-L1 or CTLA-4 immune checkpoint therapy (either together or one after the other)
• People with most cancer types in this trial who have previously received any PD-1/PD-L1 or CTLA-4 immune therapy (an exception applies for those with certain urothelial carcinoma types — confirm with trial site)
• Pregnant women, as the study drugs may harm an unborn baby; breastfeeding is also not permitted during treatment
• People who have received chemotherapy or biological cancer treatments within the 2 weeks before starting the trial
• People who have received radiation therapy to the lungs, chest, or abdomen within 4 weeks, to brain metastases within 2–3 weeks, or to any other area within 2 weeks before starting the trial, or who are still recovering from radiation side effects
• People who have received radioactive treatment (radionuclide therapy) within 6 weeks before starting the trial
• People who have received a small molecule kinase inhibitor within 14 days (or 5 half-lives, whichever is longer) before starting the trial
• People who have received hormonal cancer therapy within 14 days (or 5 half-lives, whichever is longer) before starting the trial (note: certain hormone-suppressing injections used in prostate cancer are permitted — confirm with trial site)
• People who have received any other experimental treatment within 14 days before starting the trial
• People who have not yet recovered from significant side effects of previous cancer treatments (hair loss and nerve-related side effects may be exceptions — confirm with trial site)
• People with currently active brain metastases or cancer affecting the area around the spinal cord; people with previously treated, stable brain metastases who are not on steroids and have been symptom-free for at least 2 weeks may be eligible (confirm with trial site)
• People currently taking warfarin at regular doses (low-dose warfarin up to 1 mg/day, aspirin up to 325 mg/day, and certain blood thinners such as low molecular weight heparin are permitted)
• People taking certain medications that strongly affect how the body processes drugs (strong CYP3A4 inducers or inhibitors, such as rifampin, carbamazepine, phenytoin, or St. John's Wort — confirm the full list with the trial site)
• People who have had significant gastrointestinal bleeding within the past 6 months, coughed up blood within the past month, or shown other signs of lung bleeding within the past 3 months
• People whose tumour is growing into or around a major blood vessel
• People whose tumour is growing into the digestive tract (such as the oesophagus, stomach, or bowel) or into the airways
• People with serious, uncontrolled heart conditions, including moderate-to-severe heart failure, uncontrolled high blood pressure despite treatment, a specific type of abnormal heart rhythm reading (QTcF above 500 ms), a history of inherited long QT syndrome, or a history within the past 6 months of unstable chest pain, serious heart rhythm problems, stroke or mini-stroke, heart attack, or cardiomyopathy (people with atrial fibrillation may still be eligible — confirm with trial site)
• People with active or unresolved serious gastrointestinal conditions such as peptic ulcer disease, diverticulitis, cholecystitis, or malabsorption; or those with a history within the past 2 years of bowel perforation, abdominal or genitourinary fistula, bowel obstruction, or unresolved intra-abdominal abscess
• People with a feeding tube (PEG tube) or other conditions associated with a high risk of fistula formation
• People with a serious active infection requiring intravenous antibiotics within the past 14 days
• People with a serious non-healing wound, ulcer, or bone fracture within the past 28 days
• People who have had an organ transplant or stem cell transplant
• People with uncontrolled thyroid problems within the past 7 days (people with mildly elevated thyroid levels without symptoms may be able to start thyroid replacement medication and still join — confirm with trial site)
• People who have had major surgery within the past 3 months, or minor surgery within the past month without full wound healing (confirm timing with trial site)
• People with a history of severe allergic reactions to any monoclonal antibody (a type of biological medicine)
• People with another active cancer requiring systemic treatment within the past 2 years
• People with a history of allergic reactions to cabozantinib, nivolumab, ipilimumab, or related compounds
• People with active hepatitis B or hepatitis C infection
• People with active autoimmune diseases or a history of autoimmune conditions that could affect vital organs or require immune-suppressing treatment, including conditions such as lupus, multiple sclerosis, inflammatory bowel disease, myasthenia gravis, scleroderma, autoimmune hepatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis (among others — confirm with trial site)
• People who have had active or acute diverticulitis, an abdominal abscess, or a bowel obstruction within the past 12 months

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