Todd DeVries
YOU?
Author Swipe
View article: Conditional power and information fraction calculations at an interim analysis for random coefficient models
Conditional power and information fraction calculations at an interim analysis for random coefficient models Open
Random coefficient (RC) models are commonly used in clinical trials to estimate the rate of change over time in longitudinal data. Trials utilizing a surrogate endpoint for accelerated approval with a confirmatory longitudinal endpoint to …
View article: WCN23-1117 ATRASENTAN IN PATIENTS WITH PROTEINURIC GLOMERULAR DISEASES – THE AFFINITY STUDY
WCN23-1117 ATRASENTAN IN PATIENTS WITH PROTEINURIC GLOMERULAR DISEASES – THE AFFINITY STUDY Open
Glomerular diseases are the leading cause of ESKD worldwide. IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), Alport syndrome (AS), and diabetic kidney disease (DKD) are important glomerular diseases characterized by prot…
View article: WCN23-1126 ATRASENTAN FOR THE TREATMENT OF IGA NEPHROPATHY: INTERIM RESULTS OF THE AFFINITY STUDY
WCN23-1126 ATRASENTAN FOR THE TREATMENT OF IGA NEPHROPATHY: INTERIM RESULTS OF THE AFFINITY STUDY Open
Endothelin A (ETA) receptor activation drives proteinuria, inflammation, and fibrosis in patients with glomerular diseases. Atrasentan, a potent and selective ETA receptor antagonist, represents a potential therapy to reduce proteinuria an…
View article: Data from Survival Outcomes of Sipuleucel-T Phase III Studies: Impact of Control-Arm Cross-Over to Salvage Immunotherapy
Data from Survival Outcomes of Sipuleucel-T Phase III Studies: Impact of Control-Arm Cross-Over to Salvage Immunotherapy Open
Sipuleucel-T is an autologous cellular immunotherapy for asymptomatic/minimally symptomatic metastatic castrate-resistant prostate cancer (CRPC). After disease progression, control-arm patients on three double-blind, randomized phase III s…
View article: Data from A Transient Increase in Eosinophils Is Associated with Prolonged Survival in Men with Metastatic Castration-Resistant Prostate Cancer Who Receive Sipuleucel-T
Data from A Transient Increase in Eosinophils Is Associated with Prolonged Survival in Men with Metastatic Castration-Resistant Prostate Cancer Who Receive Sipuleucel-T Open
Sipuleucel-T is an autologous cellular immunotherapy used to treat asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Traditional short-term indicators of clinical response commonly used with che…
View article: Data from Survival Outcomes of Sipuleucel-T Phase III Studies: Impact of Control-Arm Cross-Over to Salvage Immunotherapy
Data from Survival Outcomes of Sipuleucel-T Phase III Studies: Impact of Control-Arm Cross-Over to Salvage Immunotherapy Open
Sipuleucel-T is an autologous cellular immunotherapy for asymptomatic/minimally symptomatic metastatic castrate-resistant prostate cancer (CRPC). After disease progression, control-arm patients on three double-blind, randomized phase III s…
View article: Supplementary Table 1 from Survival Outcomes of Sipuleucel-T Phase III Studies: Impact of Control-Arm Cross-Over to Salvage Immunotherapy
Supplementary Table 1 from Survival Outcomes of Sipuleucel-T Phase III Studies: Impact of Control-Arm Cross-Over to Salvage Immunotherapy Open
Statistical Modeling Approaches for Survival Subsequent to Disease Progression for Control-Arm Patients Including Parameter Estimates for all Model Terms.
View article: Supplementary Table 1 from Survival Outcomes of Sipuleucel-T Phase III Studies: Impact of Control-Arm Cross-Over to Salvage Immunotherapy
Supplementary Table 1 from Survival Outcomes of Sipuleucel-T Phase III Studies: Impact of Control-Arm Cross-Over to Salvage Immunotherapy Open
Statistical Modeling Approaches for Survival Subsequent to Disease Progression for Control-Arm Patients Including Parameter Estimates for all Model Terms.
View article: Supplementary Table 1, Figures 1 - 3 from A Transient Increase in Eosinophils Is Associated with Prolonged Survival in Men with Metastatic Castration-Resistant Prostate Cancer Who Receive Sipuleucel-T
Supplementary Table 1, Figures 1 - 3 from A Transient Increase in Eosinophils Is Associated with Prolonged Survival in Men with Metastatic Castration-Resistant Prostate Cancer Who Receive Sipuleucel-T Open
Supplementary Table S1. Baseline demographics and disease characteristics in patients with mCRPC from the phase III sipuleucel-T trials included in the eosinophil analysis and the overall pooled population. Supplementary Figure S1. Overvie…
View article: Supplementary Table 1, Figures 1 - 3 from A Transient Increase in Eosinophils Is Associated with Prolonged Survival in Men with Metastatic Castration-Resistant Prostate Cancer Who Receive Sipuleucel-T
Supplementary Table 1, Figures 1 - 3 from A Transient Increase in Eosinophils Is Associated with Prolonged Survival in Men with Metastatic Castration-Resistant Prostate Cancer Who Receive Sipuleucel-T Open
Supplementary Table S1. Baseline demographics and disease characteristics in patients with mCRPC from the phase III sipuleucel-T trials included in the eosinophil analysis and the overall pooled population. Supplementary Figure S1. Overvie…
View article: Data from A Transient Increase in Eosinophils Is Associated with Prolonged Survival in Men with Metastatic Castration-Resistant Prostate Cancer Who Receive Sipuleucel-T
Data from A Transient Increase in Eosinophils Is Associated with Prolonged Survival in Men with Metastatic Castration-Resistant Prostate Cancer Who Receive Sipuleucel-T Open
Sipuleucel-T is an autologous cellular immunotherapy used to treat asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Traditional short-term indicators of clinical response commonly used with che…
View article: Supplementary Materials and Methods, Tables ST1-13 from Humoral Immune Response against Nontargeted Tumor Antigens after Treatment with Sipuleucel-T and Its Association with Improved Clinical Outcome
Supplementary Materials and Methods, Tables ST1-13 from Humoral Immune Response against Nontargeted Tumor Antigens after Treatment with Sipuleucel-T and Its Association with Improved Clinical Outcome Open
Supplementary materials and Methods, Tables ST1-13. Table ST1: Baseline clinical characteristics of patients in IMPACT Table ST2: Baseline clinical characteristics of patients in ProACT. Table ST3: Increase in levels of IgG against candida…
View article: Figure S1 from Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects
Figure S1 from Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects Open
Supplementary Figure S1 - Study schema
View article: Supplementary from Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Hormone-Sensitive Biochemically Recurrent Prostate Cancer: A Phase II Randomized Trial
Supplementary from Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Hormone-Sensitive Biochemically Recurrent Prostate Cancer: A Phase II Randomized Trial Open
Supplementary data - Table S1. Incidence of all adverse events occurring in {greater than or equal to}15% of patients as well as grade 3 to 5 adverse events* Figure S1. Study schematic. Figure S2. Time-to-PSA progression* from testosterone…
View article: Data from Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Hormone-Sensitive Biochemically Recurrent Prostate Cancer: A Phase II Randomized Trial
Data from Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Hormone-Sensitive Biochemically Recurrent Prostate Cancer: A Phase II Randomized Trial Open
Purpose: STAND, a randomized, phase II, open-label trial (NCT01431391), assessed sequencing of sipuleucel-T (an autologous cellular immunotherapy) with androgen deprivation therapy (ADT) in biochemically recurrent prostate cancer (BRPC) pa…
View article: Supplementary Figure 1 from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Supplementary Figure 1 from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer Open
Supplementary Figure 1. Schematic of the STAMP trial design.
View article: Supplementary Figure 3 from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Supplementary Figure 3 from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer Open
Supplementary Figure 3. CONSORT diagram with patient disposition.
View article: Data from Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Hormone-Sensitive Biochemically Recurrent Prostate Cancer: A Phase II Randomized Trial
Data from Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Hormone-Sensitive Biochemically Recurrent Prostate Cancer: A Phase II Randomized Trial Open
Purpose: STAND, a randomized, phase II, open-label trial (NCT01431391), assessed sequencing of sipuleucel-T (an autologous cellular immunotherapy) with androgen deprivation therapy (ADT) in biochemically recurrent prostate cancer (BRPC) pa…
View article: Data from Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects
Data from Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects Open
Sipuleucel-T is an autologous cellular therapy for asymptomatic, or minimally symptomatic, metastatic castrate-resistant prostate cancer, designed to stimulate an immune response against prostate cancer. In a recent clinical trial (NCT0071…
View article: Figure S2 from Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects
Figure S2 from Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects Open
Supplementary Figure S2 - Assessments of unique TCR sequences in the blood for healthy donors and for sipuleucel-T-treated subjects were performed on PBMCs taken before the preparation of each sipuleucel-T-treatment. A, TCR sequence profil…
View article: Supplementary Tables 1-3, Figure Legends from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Supplementary Tables 1-3, Figure Legends from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer Open
Supplementary Tables 1-3, Figure Legends. ST1. Median cumulative product parameters, all randomized patients; ST2. Summary of maximal percent decrease from baseline in serum PSA; ST3: Most common AEs occurring within 1 day of infusion in >…
View article: Supplementary from Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Hormone-Sensitive Biochemically Recurrent Prostate Cancer: A Phase II Randomized Trial
Supplementary from Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Hormone-Sensitive Biochemically Recurrent Prostate Cancer: A Phase II Randomized Trial Open
Supplementary data - Table S1. Incidence of all adverse events occurring in {greater than or equal to}15% of patients as well as grade 3 to 5 adverse events* Figure S1. Study schematic. Figure S2. Time-to-PSA progression* from testosterone…
View article: Supplementary Tables 1-3, Figure Legends from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Supplementary Tables 1-3, Figure Legends from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer Open
Supplementary Tables 1-3, Figure Legends. ST1. Median cumulative product parameters, all randomized patients; ST2. Summary of maximal percent decrease from baseline in serum PSA; ST3: Most common AEs occurring within 1 day of infusion in >…
View article: Supplementary Figure 2 from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Supplementary Figure 2 from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer Open
Supplementary Figure 2. Schematic showing how sipuleucel-T is designed to activate a patient's immune system by ex vivo cellular activation during manufacture and subsequent in vivo immune response.
View article: Data from Humoral Immune Response against Nontargeted Tumor Antigens after Treatment with Sipuleucel-T and Its Association with Improved Clinical Outcome
Data from Humoral Immune Response against Nontargeted Tumor Antigens after Treatment with Sipuleucel-T and Its Association with Improved Clinical Outcome Open
Purpose: Antitumor activity of cancer immunotherapies may elicit immune responses to nontargeted (secondary) tumor antigens, or antigen spread. We evaluated humoral antigen spread after treatment with sipuleucel-T, an immunotherapy for asy…
View article: Supplementary Figure 2 from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Supplementary Figure 2 from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer Open
Supplementary Figure 2. Schematic showing how sipuleucel-T is designed to activate a patient's immune system by ex vivo cellular activation during manufacture and subsequent in vivo immune response.
View article: Supplementary Figure SF2 from Humoral Immune Response against Nontargeted Tumor Antigens after Treatment with Sipuleucel-T and Its Association with Improved Clinical Outcome
Supplementary Figure SF2 from Humoral Immune Response against Nontargeted Tumor Antigens after Treatment with Sipuleucel-T and Its Association with Improved Clinical Outcome Open
Supplementary Figure SF2. Shown in this figure are four Kaplan-Meier (KM) plots comparing the OS of patients in the sipuleucel-T arm of IMPACT with no IgG response at week 10 (IgG responses = 0) to patients with {greater than or equal to}1…
View article: Supplementary Figure 1 from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer
Supplementary Figure 1 from A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer Open
Supplementary Figure 1. Schematic of the STAMP trial design.
View article: Data from Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects
Data from Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects Open
Sipuleucel-T is an autologous cellular therapy for asymptomatic, or minimally symptomatic, metastatic castrate-resistant prostate cancer, designed to stimulate an immune response against prostate cancer. In a recent clinical trial (NCT0071…
View article: Supplementary Figure SF1 from Humoral Immune Response against Nontargeted Tumor Antigens after Treatment with Sipuleucel-T and Its Association with Improved Clinical Outcome
Supplementary Figure SF1 from Humoral Immune Response against Nontargeted Tumor Antigens after Treatment with Sipuleucel-T and Its Association with Improved Clinical Outcome Open
Supplementary Figure SF1. Schematic of sipuleucel-T treatment doses (infusions) and serum collection time points in IMPACT and ProACT.