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 886 people with kidney cancer — 442 received a combination of two medicines called avelumab and axitinib, and 444 received a medicine called sunitinib. The trial was measuring how long participants went without their disease getting worse (called progression-free survival), how long participants lived overall (overall survival), and what proportion of participants saw their tumours shrink or disappear (objective response). Some results were reported specifically for participants whose tumours tested positive for a protein called PD-L1, and some results covered all participants regardless of that test. The reported data shows the following numbers for participants whose tumours were PD-L1 positive: the median time before disease worsening was 13.8 months in the avelumab-plus-axitinib group compared with 7.2 months in the sunitinib group; the median overall survival was 43.2 months versus 36.2 months respectively. (Median means half the participants in that group had a result above this number and half below.) When looking at all participants regardless of PD-L1 status, the reported median time before disease worsening was 13.8 months for avelumab-plus-axitinib versus 8.4 months for sunitinib, and median overall survival was 44.8 months versus 38.9 months. The reported data also shows that, across all participants, the proportion whose tumours shrank or disappeared was 51.4% in the avelumab-plus-axitinib group compared with 25.7% in the sunitinib group, based on independent central review; a separate assessment by the treating investigators recorded 59.7% versus 32.0% respectively. It is worth noting that none of the participants were recorded as having formally "completed" the trial under the study's own definition, which the data does not explain further. 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 39886142) ↗
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, Completed
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:
- You have been diagnosed with advanced or spreading kidney cancer (renal cell carcinoma) that has been confirmed by a lab test and contains a specific type called "clear cell"
- You are able to provide a preserved tumor tissue sample (either a new biopsy taken during the screening period, or a recent archived sample taken within the last year with no cancer treatment received since then)
- You are also able to provide a preserved tissue sample from the original tumor removal surgery, if not already covered above
- You have at least one measurable tumor that has not previously been treated with radiation
- You are fairly active and able to carry out daily activities with little or no limitation (this is measured on a standard scale called ECOG, scores 0 or 1)
- Your blood counts, kidney function, and liver function are all at acceptable levels
Who may not be able to join:
- You have previously received any systemic (whole-body) treatment specifically for advanced or metastatic kidney cancer
- You received pre- or post-surgery drug treatment for kidney cancer and your cancer came back or got worse during that treatment or within 12 months of finishing it
- You have previously received certain immune-boosting or immune checkpoint therapies (such as ipilimumab, anti-PD-1, anti-PD-L1, or similar drugs that target the immune system's "brakes")
- You have previously been treated with axitinib, sunitinib, or any other drug that works by blocking a pathway called VEGF
- You have newly diagnosed or currently active cancer that has spread to the brain
- You have had a severe allergic reaction (grade 3 or higher) to a type of drug called monoclonal antibodies, have any history of a severe sudden allergic reaction (anaphylaxis), or have poorly controlled asthma
- You have had any of the following in the past 12 months: heart attack, severe chest pain (unstable angina), heart or artery bypass surgery, significant heart failure, low heart pumping function, significant fluid around the heart, stroke, or a mini-stroke (TIA)
- You have had a serious blood clot in a vein or lungs in the past 6 months
- You have received a live vaccine within 4 weeks before starting the trial, or plan to receive one during the trial (non-live vaccines, such as standard flu shots, are generally acceptable — confirm with trial site)
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
Principal Investigator: Pfizer CT.gov Call Center, Pfizer
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
24 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants; Overall Survival (OS) in PD-L1 Positive Participants
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.