Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
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; = 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 ( = 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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9142735 | PMC |
| http://dx.doi.org/10.1016/j.euros.2022.03.012 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Increasing Awareness and Early Detection of Common Skin Diseases in Indonesia Through an mHealth App: Protocol for an Awareness and Acceptability Study and Randomized Controlled Trial.
JMIR Res Protoc
September 2025
Department of Public Health, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Background: Various media are used to enhance public understanding about diseases. While mobile health apps are widely used, there is little proof for using such apps to raise awareness of skin diseases.
Objective: We intend to develop an app, called DEDIKASI-app, to raise awareness of skin diseases, including leprosy.
Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial.
JAMA Intern Med
September 2025
Bayer CC AG, Basel, Switzerland.
Importance: There is an unmet need for long-term, safe, effective, and hormone-free treatments for menopausal symptoms, including vasomotor symptoms (VMS) and sleep disturbances.
Objective: To evaluate the 52-week efficacy and safety of elinzanetant, a dual neurokinin-targeted therapy, for treating moderate to severe VMS associated with menopause.
Design, Setting, And Participants: OASIS-3 was a double-blind, placebo-controlled, randomized phase 3 clinical trial that was conducted at 83 sites in North America and Europe from August 27, 2021, to February 12, 2024, and included postmenopausal women aged 40 to 65 years who were seeking treatment for moderate to severe VMS (no requirement for a minimum number of VMS events per week).
Design of Two Randomized, Placebo-Controlled, Phase 3 Trials of Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in Systemic Lupus Erythematosus.
Adv Ther
September 2025
Bristol Myers Squibb, Princeton, NJ, 08540, USA.
Background And Objectives: Deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 inhibitor, demonstrated efficacy across the primary endpoint and all key secondary endpoints in the phase 2 PAISLEY SLE trial in patients with active systemic lupus erythematosus (SLE). Here, we describe 2 phase 3 trials [POETYK SLE-1 (NCT05617677), POETYK SLE-2 (NCT05620407)] which will assess the efficacy and safety of deucravacitinib in patients with active SLE. These phase 3 trials have been designed to replicate the successful elements of the phase 2 trial, including its glucocorticoid-tapering strategy and disease activity adjudication.
View Article and Find Full Text PDFModels for polymer dynamics from dimensionality reduction techniques.
J Chem Phys
September 2025
Department of Physics and Astronomy and Stewart Blusson Quantum Matter Institute, University of British Columbia, Vancouver, British Columbia V6T 1Z1, Canada.
Polymer dynamics is analyzed through the lens of linear dimensionality reduction methods, in particular principal and time-lagged independent component analysis (tICA). For a polymer undergoing ideal Rouse dynamics, the slow modes identified by these transformations coincide with the conventional Rouse modes. When applied to the Fourier modes of the segment density, we show that tICA generates dynamics equivalent to dynamic self-consistent field theory (D-SCFT) with a wavevector-dependent Onsager coefficient and a free energy functional subject to the random phase approximation.
View Article and Find Full Text PDFHybrid rye grain inclusion strategies as a replacement for corn grain in finishing cattle diets: effects on growth performance and carcass characteristics.
Transl Anim Sci
May 2025
Department of Animal Science, South Dakota State University, Brookings, SD 57007, USA.
Two experiments were conducted to evaluate the effects of feeding dry-rolled hybrid rye grain (DRRG) as a replacement for dry-rolled corn (DRC) in beef cattle finishing diets. Two inclusion strategies for rye grain (RG) were evaluated: a total replacement of DRC for a limited time and a partial replacement during the entire feeding trial for Exp. 1 and 2, respectively.
View Article and Find Full Text PDF