Trial results for the Phase 2 study (NCT03595124) investigating nivolumab in TFE/translocation renal cell carcinoma (tRCC) were posted on ClinicalTrials.gov on 2025-10-10. The study showed that the combination of axitinib and nivolumab resulted in a 33% progression-free survival (PFS) and overall response rate (ORR), compared to 0% for nivolumab alone.
Background
The study investigated treatments for TFE/translocation renal cell carcinoma (tRCC), including unresectable or metastatic forms. Axitinib is designed to inhibit tumor cell growth by blocking enzymes, while nivolumab is an immunotherapy that aims to help the body's immune system target cancer cells and prevent their growth and spread.
Trial design
The study NCT03595124 was a Phase 2 trial with an enrollment of 15 participants. It focused on patients with metastatic renal cell carcinoma, Stage III renal cell cancer AJCC v8, Stage IV renal cell cancer AJCC v8, TFE3-Rearranged renal cell carcinoma, and unresectable renal cell carcinoma. The interventions included axitinib and nivolumab, administered either as a combination (Arm A) or nivolumab alone (Arm C).
Key results
The trial reported several key outcome measurements:
- For Progression Free Survival (PFS), Arm A (Axitinib, Nivolumab) showed a 33% percentage of participants, while Arm C (Nivolumab) showed a 0% percentage of participants. Both outcomes were reported with a 70% Confidence Interval.
- For Overall Survival (OS), Arm A (Axitinib, Nivolumab) showed a 100% percentage of participants, compared to 80% for Arm C (Nivolumab). Both outcomes were reported with a 70% Confidence Interval.
- For Overall Response Rate (ORR), Arm A (Axitinib, Nivolumab) achieved a 33% percentage of participants, whereas Arm C (Nivolumab) showed a 0% percentage of participants. Both outcomes were reported with a 70% Confidence Interval.
- Regarding the Percentage of Patients Experiencing Adverse Events (AEs), Arm A (Axitinib, Nivolumab) reported 50% of participants, while Arm C (Nivolumab) reported 80% of participants. Both outcomes were reported with a 70% Confidence Interval.
What this means
The results from this Phase 2 study suggest that the combination of axitinib and nivolumab may offer improved outcomes in patients with TFE/translocation renal cell carcinoma compared to nivolumab monotherapy. Specifically, the combination arm demonstrated a higher progression-free survival and overall response rate. Additionally, the combination therapy was associated with a lower percentage of participants experiencing adverse events compared to nivolumab alone in this small cohort.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03595124, titled "A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC)," were posted on 2025-10-10 on clinicaltrials.gov.