In silico cancer immunotherapy trials uncover the consequences of therapy-specific response patterns for clinical trial design and outcome

Rethinking the immunotherapy numbers game

(2022) Rebecca A Bekker et al.   Journal for ImmunoTherapy of Cancer

First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial

(2021) Paul Baas et al.   LANCET

Cytotoxic T cells are able to efficiently eliminate cancer cells by additive cytotoxicity

(2021) Bettina Weigelin et al.   Nature Communications

Mathematical prediction of clinical outcomes in advanced cancer patients treated with checkpoint inhibitor immunotherapy

(2020) Joseph D. Butner et al.   Science Advances

Clinical Challenges of Immune Checkpoint Inhibitors

(2020) Maria de Miguel et al.   CANCER CELL

Opportunities for Quantitative Translational Modeling in Oncology

(2020) James W.T. Yates et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Clinical trial design: Past, present, and future in the context of big data and precision medicine

(2020) Allen Li et al.   CANCER

Immuno-oncology drug development forges on despite COVID-19

(2020) Samik Upadhaya et al.   NATURE REVIEWS DRUG DISCOVERY

Translational approaches to treating dynamical diseases through in silico clinical trials

(2020) Sofia Alfonso et al.   CHAOS

Modeling the effect of immunotherapies on human castration-resistant prostate cancer

(2020) Roberta Coletti et al.   JOURNAL OF THEORETICAL BIOLOGY

Efficient and flexible simulation-based sample size determination for clinical trials with multiple design parameters

(2020) Duncan T Wilson et al.   STATISTICAL METHODS IN MEDICAL RESEARCH

Trends in clinical success rates and therapeutic focus

(2019) Helen Dowden et al.   NATURE REVIEWS DRUG DISCOVERY

In silico simulation of a clinical trial with anti-CTLA-4 and anti-PD-L1 immunotherapies in metastatic breast cancer using a systems pharmacology model

(2019) Hanwen Wang et al.   Royal Society Open Science

A Computational Model of Neoadjuvant PD-1 Inhibition in Non-Small Cell Lung Cancer

(2019) Mohammad Jafarnejad et al.   AAPS Journal

Deviation from the Proportional Hazards Assumption in Randomized Phase 3 Clinical Trials in Oncology: Prevalence, Associated Factors and Implications

(2019) Rifaquat M Rahman et al.   CLINICAL CANCER RESEARCH

Computational design of improved standardized chemotherapy protocols for grade II oligodendrogliomas

(2019) Víctor M. Pérez-García et al.   PLoS Computational Biology

Response of Patients with Melanoma to Immune Checkpoint Blockade – Insights Gleaned from Analysis of a New Mathematical Mechanistic Model

(2019) N. Tsur et al.   JOURNAL OF THEORETICAL BIOLOGY

Nivolumab plus Ipilimumab in Advanced Non–Small-Cell Lung Cancer

(2019) Matthew D. Hellmann et al.   NEW ENGLAND JOURNAL OF MEDICINE

Predicting response to pembrolizumab in metastatic melanoma by a new personalization algorithm

(2019) Neta Tsur et al.   Journal of Translational Medicine

A QSP Model for Predicting Clinical Responses to Monotherapy, Combination and Sequential Therapy Following CTLA-4, PD-1, and PD-L1 Checkpoint Blockade

(2019) Oleg Milberg et al.   Scientific Reports

A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data

(2019) Li-Tzong Chen et al.   Gastric Cancer

Estimation of clinical trial success rates and related parameters

(2018) Chi Heem Wong et al.   BIOSTATISTICS

Evaluation of Overall Response Rate and Progression-Free Survival as Potential Surrogate Endpoints for Overall Survival in Immunotherapy Trials

(2018) Sirisha L. Mushti et al.   CLINICAL CANCER RESEARCH

Reduced tyrosine kinase inhibitor dose is predicted to be as effective as standard dose in chronic myeloid leukemia: A simulation study based on phase 3 trial data

(2018) Artur C. Fassoni et al.   HAEMATOLOGICA

Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST): Refining Guidelines to Assess the Clinical Benefit of Cancer Immunotherapy

(2018) F. Stephen Hodi et al.   JOURNAL OF CLINICAL ONCOLOGY

Toxicity profiles of immunotherapy

(2018) S. Cousin et al.   PHARMACOLOGY & THERAPEUTICS

In silico clinical trials for pediatric orphan diseases

(2018) A. Carlier et al.   Scientific Reports

Reduced tyrosine kinase inhibitor dose is predicted to be as effective as standard dose in chronic myeloid leukemia: A simulation study based on phase 3 trial data

(2018) Artur C. Fassoni et al.   HAEMATOLOGICA

Designing Late-Stage Randomized Clinical Trials with Cancer Immunotherapy: Can We Make It Simpler?

(2018) Tai-Tsang Chen   Cancer Immunology Research

Applications of mechanistic modelling to clinical and experimental immunology: an emerging technology to accelerate immunotherapeutic discovery and development

(2018) L. V. Brown et al.   CLINICAL AND EXPERIMENTAL IMMUNOLOGY

Development of tumor mutation burden as an immunotherapy biomarker: utility for the oncology clinic

(2018) T A Chan et al.   ANNALS OF ONCOLOGY

Survival Outcomes in Patients With Previously Untreated BRAF Wild-Type Advanced Melanoma Treated With Nivolumab Therapy

(2018) Paolo A. Ascierto et al.   JAMA Oncology

Addressing current challenges in cancer immunotherapy with mathematical and computational modelling

(2017) Anna Konstorum et al.   Journal of the Royal Society Interface

iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics

(2017) Lesley Seymour et al.   LANCET ONCOLOGY

Durable response rate as an endpoint in cancer immunotherapy: insights from oncolytic virus clinical trials

(2017) Howard L. Kaufman et al.   Journal for ImmunoTherapy of Cancer

Predicting analysis times in randomized clinical trials with cancer immunotherapy

(2016) Tai-Tsang Chen   BMC Medical Research Methodology

Microsatellite Instability as a Biomarker for PD-1 Blockade

(2016) J. C. Dudley et al.   CLINICAL CANCER RESEARCH

Colorectal Cancer Initial Diagnosis: Screening Colonoscopy, Diagnostic Colonoscopy, or Emergent Surgery, and Tumor Stage and Size at Initial Presentation

(2016) Courtney C. Moreno et al.   Clinical Colorectal Cancer

From concept to clinic: Mathematically informed immunotherapy

(2016) Rachel Walker et al.   CURRENT PROBLEMS IN CANCER

Employing dynamical computational models for personalizing cancer immunotherapy

(2016) Zvia Agur et al.   EXPERT OPINION ON BIOLOGICAL THERAPY

Designing therapeutic cancer vaccine trials with delayed treatment effect

(2016) Zhenzhen Xu et al.   STATISTICS IN MEDICINE

Power and Sample Size Calculations in Clinical Trials with Patient-Reported Outcomes under Equal and Unequal Group Sizes Based on Graded Response Model: A Simulation Study

(2016) Marziyeh Doostfatemeh et al.   VALUE IN HEALTH

Failure of Investigational Drugs in Late-Stage Clinical Development and Publication of Trial Results

(2016) Thomas J. Hwang et al.   JAMA Internal Medicine

Personalized cancer immunotherapy using Systems Medicine approaches

(2015) Shailendra K. Gupta et al.   BRIEFINGS IN BIOINFORMATICS

Novel model-based dosing guidelines for gentamicin and tobramycin in preterm and term neonates

(2015) P. A. J. Valitalo et al.   JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Five-Year Survival Rates for Treatment-Naive Patients With Advanced Melanoma Who Received Ipilimumab Plus Dacarbazine in a Phase III Trial

(2015) Michele Maio et al.   JOURNAL OF CLINICAL ONCOLOGY

Milestone Survival: A Potential Intermediate Endpoint for Immune Checkpoint Inhibitors

(2015) Tai-Tsang Chen   JNCI-Journal of the National Cancer Institute

PD-L1 Expression as a Predictive Biomarker in Cancer Immunotherapy

(2015) S. P. Patel et al.   MOLECULAR CANCER THERAPEUTICS

Trauma in silico: Individual-specific mathematical models and virtual clinical populations

(2015) David Brown et al.   Science Translational Medicine

Milestone Survival: A Potential Intermediate Endpoint for Immune Checkpoint Inhibitors

(2015) Tai-Tsang Chen   JNCI-Journal of the National Cancer Institute

Statistical Challenges in the Design of Late-Stage Cancer Immunotherapy Studies

(2015) R. Mick et al.   Cancer Immunology Research

Rcpp: SeamlessRandC++Integration

(2015) Dirk Eddelbuettel et al.   Journal of Statistical Software

A General Functional Response of Cytotoxic T Lymphocyte-Mediated Killing of Target Cells

(2014) Saikrishna Gadhamsetty et al.   BIOPHYSICAL JOURNAL

Modeling cancer-immune responses to therapy

(2014) L. G. dePillis et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Primary Tumor Size in Renal Cell Cancer in Relation to the Occurrence of Synchronous Metastatic Disease

(2014) Stefan Zastrow et al.   UROLOGIA INTERNATIONALIS

Alternate virtual populations elucidate the type I interferon signature predictive of the response to rituximab in rheumatoid arthritis

(2013) Brian J Schmidt et al.   BMC BIOINFORMATICS

Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome

(2013) Patrick Royston et al.   BMC Medical Research Methodology

The complex relationship between lung tumor volume and survival in patients with non-small cell lung cancer treated by definitive radiotherapy: A prospective, observational prognostic factor study of the Trans-Tasman Radiation Oncology Group (TROG 99.05)

(2013) David L. Ball et al.   RADIOTHERAPY AND ONCOLOGY

Statistical issues and challenges in immuno-oncology

(2013) Tai-Tsang Chen   Journal for ImmunoTherapy of Cancer

From the evolution of toxin resistance to virtual clinical trials: the role of mathematical models in oncology

(2010) Zvia Agur   Future Oncology

Improved Endpoints for Cancer Immunotherapy Trials

(2010) A. Hoos et al.   JNCI-Journal of the National Cancer Institute

Guidelines for the Evaluation of Immune Therapy Activity in Solid Tumors: Immune-Related Response Criteria

(2009) J. D. Wolchok et al.   CLINICAL CANCER RESEARCH