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Ilixadencel, a Cell-based Immune Primer, plus Sunitinib Versus Sunitinib Alone in Metastatic Renal Cell Carcinoma: A
Magnus Lindskog1, Anna Laurell2, Anders Kjellman3
1Department of Immunology, Genetics and Pathology, Uppsala University Hospital, Uppsala University, Uppsala, Sweden.
Background:
The prognosis of patients with synchronous metastatic renal cell carcinoma (mRCC) is poor. Whereas single-agent tyrosine kinase inhibition (TKI) is clearly insufficient, the effects can be enhanced by combinations with immune checkpoint inhibitors. Innovative treatment options combining TKI and other immune-stimulating agents could prove beneficial.
Objective:
To evaluate the clinical effects on metastatic disease when two doses of allogeneic monocyte-derived dendritic cells (ilixadencel) are administrated intratumorally followed by nephrectomy and treatment with sunitinib compared with nephrectomy and sunitinib monotherapy, in patients with synchronous mRCC.
Design Setting And Participants:
A randomized (2:1) phase 2 multicenter trial enrolled 88 patients with newly diagnosed mRCC to treatment with the combination ilixadencel/sunitinib (ILIXA/SUN; 58 patients) or sunitinib alone (SUN; 30 patients).
Outcome Measurements And Statistical Analysis:
The primary endpoints were 18-mo survival rate and overall survival (OS). A secondary endpoint was objective response rate (ORR) assessed up to 18 mo after enrollment. Statistic evaluations included Kaplan-Meier estimates, log-rank tests, Cox regression, and stratified Cochran-Mantel-Haenszel tests.
Results And Limitations:
The median OS was 35.6 mo in the ILIXA/SUN arm versus 25.3 mo in the SUN arm (hazard ratio 0.73, 95% confidence interval 0.42-1.27; p = 0.25), while the 18-mo OS rates were 63% and 66% in the ILIXA/SUN and SUN arms, respectively. The confirmed ORR in the ILIXA/SUN arm were 42.2% (19/45), including three patients with complete response, versus 24.0% (six/25) in the SUN arm (p = 0.13) without complete responses. The study was not adequately powered to detect modest differences in survival.
Conclusions:
The study failed to meet its primary endpoints. However, ilixadencel in combination with sunitinib was associated with a numerically higher, nonsignificant, confirmed response rate, including complete responses, compared with sunitinib monotherapy.
Patient Summary:
We studied the effects of intratumoral vaccination with ilixadencel followed by sunitinib versus sunitinib only in a randomized phase 2 study. The combination treatment showed numerically higher numbers of confirmed responses, suggesting an immunologic effect.
Insights
This study investigated combining ilixadencel (a dendritic cell therapy) with sunitinib for metastatic renal cell carcinoma. While not meeting primary survival endpoints, the combination showed a higher response rate, suggesting potential immunologic benefits.
Area of Science:
- Oncology
- Immunotherapy
- Nephrology
Background:
- Prognosis for synchronous metastatic renal cell carcinoma (mRCC) is poor.
- Single-agent tyrosine kinase inhibitors (TKIs) are insufficient for mRCC.
- Combinations of TKIs with immune checkpoint inhibitors may enhance treatment effects.
Purpose of the Study:
- To evaluate the clinical effects of intratumoral ilixadencel followed by nephrectomy and sunitinib versus sunitinib monotherapy in synchronous mRCC patients.
- To compare 18-month survival rates, overall survival (OS), and objective response rates (ORR).
Main Methods:
- A randomized (2:1) phase 2 multicenter trial.
- 88 patients with newly diagnosed mRCC were enrolled.
- Treatment arms: ilixadencel/sunitinib (ILIXA/SUN) or sunitinib alone (SUN).
Main Results:
- Median OS: 35.6 months (ILIXA/SUN) vs. 25.3 months (SUN) (p=0.25).
- 18-mo OS rates: 63% (ILIXA/SUN) vs. 66% (SUN).
- Confirmed ORR: 42.2% (ILIXA/SUN) vs. 24.0% (SUN) (p=0.13), including complete responses in the ILIXA/SUN arm.
Conclusions:
- The study did not meet its primary endpoints for survival.
- Ilixadencel plus sunitinib demonstrated a numerically higher, though nonsignificant, confirmed response rate compared to sunitinib monotherapy.
- The combination suggests a potential immunologic effect in mRCC treatment.
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