Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,069 people across three groups — 357 in each group — who were assigned to one of three treatment combinations: lenvatinib plus everolimus, lenvatinib plus pembrolizumab, or sunitinib alone (which served as the comparison group). The trial was primarily measuring how long participants went without their disease getting worse or dying — a period called "progression-free survival." Several other outcomes, including overall survival, response rates, and side-effect data, were also planned but had not yet been reported at the time of this data submission, as the study's anticipated completion date is March 2026. The reported data shows that, on average, participants in the lenvatinib plus everolimus group went 14.7 months before their disease progressed or they died, while those in the lenvatinib plus pembrolizumab group went 23.9 months. In the sunitinib group, that figure was 9.2 months. These numbers represent the midpoint estimate (meaning half of participants in each group reached that point sooner, and half took longer). Because the secondary outcomes — including overall survival, response rates, and safety data — are not yet reported, those figures are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 39885377) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Kidney Cancer Trial, Active, Not Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- A person who has been confirmed by tissue or cell testing to have kidney cancer (renal cell carcinoma) that contains a "clear-cell" component.
- A person whose kidney cancer has been documented as advanced (spread beyond the kidney).
- A person who has at least one tumour that can be measured on a CT or MRI scan and meets specific size requirements — either a lymph node lesion measuring at least 1.5 cm, or another lesion measuring at least 1.0 cm.
- A person who has a functional ability score (called Karnofsky Performance Status) of 70 or above, meaning they are reasonably able to care for themselves (confirm with trial site).
- A person whose blood pressure is at or below 150/90 mmHg at screening, whether or not they take blood pressure medication, and whose blood pressure medications have not changed in the week before starting the trial.
- A person whose kidneys are working well enough, based on blood test results showing creatinine levels within acceptable limits or a calculated kidney function score of at least 30 mL/min.
- A person whose bone marrow is producing enough blood cells, based on blood tests showing: neutrophil count at or above 1,500/mm³, platelets at or above 100,000/mm³, and haemoglobin at or above 9 g/dL — without relying on transfusions or blood-stimulating injections in the previous 2 weeks.
- A person whose blood clotting function is within acceptable limits (INR at or below 1.5, or within a safe range if already on blood thinners).
- A person whose liver function tests are within acceptable limits based on specific blood test results (confirm exact values with trial site).
- A person who is willing and able to sign a consent form and follow all parts of the trial plan.
Who may not be able to join:
- A person who has previously received any systemic (whole-body) cancer treatment for kidney cancer, including anti-VEGF therapies or other investigational cancer drugs (unless there is evidence they were assigned to a placebo group in a prior trial).
- A person who has cancer that has spread to the brain or spinal cord, unless that cancer was treated and stable for at least 4 weeks, and steroid medication for it was stopped at least 4 weeks before starting the trial.
- A person who has had another active cancer in the past 24 months, other than kidney cancer, certain treated skin cancers, or early-stage cervical or bladder cancer. People with a history of low-risk, localised prostate cancer that was treated with curative intent and has not returned (no PSA recurrence in the past 5 years) may still be eligible (confirm with trial site).
- A person who has had radiation therapy within the past 21 days, except for radiation to bone for pain relief, which is allowed if completed at least 2 weeks before starting the trial.
- A person who is currently using or has used another investigational (experimental) drug within the past 4 weeks.
- A person who has received a live vaccine within 30 days before the planned trial start date — examples include measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, typhoid, or nasal flu spray (note: injected flu vaccines are generally acceptable).
- A person who has a significant level of protein in their urine (1 gram or more in a 24-hour urine collection test).
- A person with very high fasting cholesterol (above 300 mg/dL) or very high fasting triglycerides (above 2.5 times the upper limit of normal) — though this may be addressed by starting or adjusting cholesterol-lowering medication before joining.
- A person with poorly controlled diabetes, shown by a fasting blood sugar level above 1.5 times the upper limit of normal — though this may be addressed by starting or adjusting diabetes medication before joining.
- A person with a significantly prolonged heart electrical signal (QTc interval greater than 480 milliseconds on an ECG).
- A person who has not fully recovered from side effects or complications of major surgery.
- A person with a condition that affects how the gut absorbs medication, such as bowel surgery or a malabsorption disorder.
- A person with bleeding disorders, blood clot disorders, or who is at high risk of severe bleeding.
- A person who has coughed up a significant amount of blood or had tumour bleeding within the past 2 weeks.
- A person who has had a significant heart condition within the past 12 months, such as severe heart failure, unstable chest pain, a heart attack, stroke, or dangerous heart rhythm problems. Low heart pumping function (below the normal range for the trial site) also applies.
- A person who has an active infection currently requiring treatment with antibiotics or other systemic medications.
- A person who is known to be HIV positive.
- A person with active hepatitis B or hepatitis C infection.
- A person with a known history of, or current, interstitial lung disease (scarring or inflammation of the lungs).
- A person who has a history of non-infectious lung inflammation (pneumonitis) that required steroid treatment, or who currently has pneumonitis.
- A person who has an immune system deficiency, or who is taking steroid medication at doses above 10 mg per day of prednisone (or equivalent), or any other immune-suppressing treatment, within 7 days before the first dose.
- A person with an active autoimmune disease (other than psoriasis) that has required systemic treatment in the past 2 years. Hormone or gland replacement therapies are not considered systemic treatment for this purpose.
- A person who is pregnant or breastfeeding at the time of screening.
- A woman of childbearing potential who does not agree to use a highly effective form of contraception throughout the entire trial and for 120 days after finishing, or who does not have a partner who has had a confirmed vasectomy.
- A man who has not had a confirmed vasectomy and does not agree to use a condom with spermicide throughout the trial and for 120 days after the last dose, or whose female partner is not using highly effective contraception (unless fully abstinent).
- A person who is known to be intolerant or allergic to any of the study drugs or their ingredients.
- A person who has received an organ or tissue transplant from another person (allogeneic transplant).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression-free Survival (PFS) by Independent Imaging Review (IIR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.