Table of Contents
- Clinical trials overview
- Kidney cancer studies
- Other cancer studies
- Trial phases and patient groups
- What the trials measure
- Key patient takeaways
Clinical trials overview
These studies investigate Axitinib in different cancer settings, mainly as part of combination treatment plans or as a comparison against other treatment strategies.[1] The trials are designed to learn about safety, efficacy (how well a treatment works), and which patients may benefit most from treatment based on cancer type or tumor features.[1][2]
The trial data include studies in kidney cancer, gastrointestinal stromal tumor, brain tumors in children and young adults, advanced solid tumors, and advanced pancreatic cancer.[1][2] Some trials are completed, while many are still authorised and ongoing.[1][2]
Kidney cancer studies
Most of the Axitinib research in this data set is in renal cell carcinoma, which is a common type of kidney cancer.[1] Several studies focus on metastatic disease, meaning the cancer has spread, while others look at locally advanced or localized disease.[1][2]
The ITALIC-RCC study is a Phase 3 trial in metastatic or locally advanced renal cell carcinoma, with 409 participants, and it compares survival in patients who do or do not receive deferred cytoreductive nephrectomy while on standard treatment.[1] Cytoreductive nephrectomy means surgery to remove the kidney tumor, and “deferred” means the surgery is done later, after treatment has started.[1]
NCT05096390 is a Phase 2 study in locally advanced or metastatic papillary renal cell carcinoma, and it compares axitinib plus pembrolizumab with axitinib alone in first-line treatment.[2] Its main outcome is objective response rate, which measures how many patients have a measurable tumor shrinkage.[2]
NCT05817903 is a Phase 2 study in metastatic renal cell carcinoma that tests axitinib intensification plus standard of care after induction with nivolumab plus ipilimumab in patients without a previous complete response.[3] The trial is looking at overall response rate to see whether adding Axitinib improves treatment results compared with standard care alone.[3]
2024-515825-27-00 studies neoadjuvant Axitinib plus avelumab in localized renal cell carcinoma with a moderate to high risk of recurrence.[8] Neoadjuvant means treatment given before the main treatment, often before surgery, and the main endpoint is the rate of partial remission after treatment.[8]
2023-503317-29-00 is a large Phase 3 platform study in metastatic renal cell carcinoma that compares an immune checkpoint inhibitor combination with a VEGFR TKI combination in previously untreated patients with intermediate or poor risk disease.[7] The study uses PDL1 status to guide the comparison and measures overall survival, progression-free survival, response rate, quality of life, safety, and health economic outcomes.[7]
NCT05219318 studies treatment pause versus treatment continuation in metastatic renal cell carcinoma patients who had an objective response after 12 months of PD-1/PDL1 inhibitor plus VEGFR-TKI treatment.[10] Axitinib is one of the VEGFR-TKI options in this trial, and the main question is whether stopping treatment is non-inferior to continuing it.[10]
NCT02853331 is a completed Phase 3 study that compared pembrolizumab plus Axitinib with sunitinib alone in metastatic renal cell carcinoma.[11] The trial measured progression-free survival and overall survival using blinded independent central imaging review.[11]
NCT07227415 is an early Phase 1 study in adults with advanced or metastatic renal cell carcinoma that tests PF-08634404 alone and in combinations, including a cohort with Axitinib.[12] The trial looks at confirmed objective response rate, dose-limiting toxicities, and safety.[12]
Other cancer studies
NCT04258956 is a completed Phase 2 study in gastrointestinal stromal tumors, a type of tumor that starts in the digestive tract.[4] It tested avelumab plus Axitinib after failure of standard therapy, and the main outcome was the rate of patients who were free from disease progression at 3 months.[4]
NCT06485908 is a Phase 1/2 study for children and young adults with refractory or relapsing medulloblastoma and ependymoma.[6] The first stage checks dose-limiting toxicity, and the second stage measures progression-free survival after Axitinib is combined with oral metronomic etoposide.[6]
NCT02925234 is a very large Phase 2 precision-medicine trial in advanced solid tumors, non-Hodgkin lymphoma, T-cell prolymphocytic leukemia, and multiple myeloma.[5] Axitinib is one of many targeted drugs used in this study, which matches treatment to a molecular tumor profile and measures tumor response, stable disease, and serious side effects.[5]
2025-522431-34-00 studies advanced pancreatic cancer and includes Axitinib among many targeted treatment options chosen for patients with actionable molecular alterations.[13] The main endpoint is progression-free survival, which helps show whether treatment can delay cancer growth.[13]
2023-505360-11-00 includes Axitinib among several cancer treatments in a Phase 2 study of solid tumours that explores immune blood markers linked to immune-related toxicities.[9] This trial also tracks safety using standard adverse event grading.[9]
Trial phases and patient groups
The trial phases in this data set range from Phase 1 to Phase 3.[1][2] Phase 1 studies mainly check dose and early safety, Phase 2 studies look for signs of benefit, and Phase 3 studies compare treatment strategies in larger groups.[6][7][11]
Most participants are adults with advanced or metastatic kidney cancer, but some studies include people with other cancers, and one study includes children and young adults with brain tumors.[1][6][13]
Some trials focus on patients who have already received treatment, such as those with disease after standard therapy or after a response to immunotherapy combinations.[4][10] Other studies include patients who are treatment-naive, meaning they have not yet received prior systemic treatment for that cancer stage.[7]
What the trials measure
The main trial outcomes include overall survival, progression-free survival, objective response rate, and partial remission.[1][2][8][11]
Some studies also measure disease control, stable disease, treatment-related serious side effects, and treatment changes caused by side effects.[5][7][12]
In the pediatric brain tumor study, the early safety endpoint is dose-limiting toxicity, while the later endpoint is progression-free survival based on central review of imaging.[6] In the gastrointestinal stromal tumor study, the main endpoint is the proportion of patients who remain progression-free at 3 months.[4]
Several trials also use standard cancer response rules such as RECIST 1.1, which is a common way to measure whether a tumor has shrunk, stayed stable, or grown.[2][4][11]
Key patient takeaways
The trial data show that Axitinib is being studied mostly in kidney cancer, especially metastatic renal cell carcinoma, but also in other cancer types.[1][2][13]
Many studies test Axitinib in combination with immunotherapy or other anticancer drugs, while some compare it with standard treatment or treatment continuation decisions.[2][7][10]
Across the trials, researchers are mainly trying to learn whether treatment can help people live longer, keep the cancer from growing, and control side effects.[1][5][11]
