I. Braña

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A Multi-Arm Phase I Study of the PI3K/mTOR Inhibitors PF-04691502 and Gedatolisib (PF-05212384) plus Irinotecan or the MEK Inhibitor PD-0325901 in Advanced Cancer

J. Tabernero, K. Kern, H. Soares, 2017, Targeted Oncology.

Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study

Hung-Ming Wang, R. Greil, K. Harrington, 2019, The Lancet.

Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score

R. Greil, K. Harrington, I. Braña, 2022, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Capturing Hyperprogressive Disease with Immune-Checkpoint Inhibitors Using RECIST 1.1 Criteria

J. Carles, E. Felip, J. Tabernero, 2019, Clinical Cancer Research.

Effect of COVID-19 pandemic lockdowns on planned cancer surgery for 15 tumour types in 61 countries: an international, prospective, cohort study

Dinh Q. Phung, C. A. Shaw, M. Kumar, 2021, The Lancet Oncology.

Molecular screening programmes for precision medicine: lessons learned from personalized medicine trials

H. Aguilar, I. Braña, A. Vivancos, 2016 .

The Personalization of Therapy: Molecular Profiling Technologies and Their Application.

I. Braña, Jorge Zerón-Medina, J. Rodon, 2015, Seminars in oncology.

Confounding factors in the assessment of oral mucositis in head and neck cancer

I. Braña, S. Elad, P. Bossi, 2022, Supportive Care in Cancer.

Drugs in clinical trials

J. Tabernero, R. Dienstmann, I. Braña, 2011 .

Evolution of clinical trial design in early drug development: systematic review of expansion cohort use in single-agent phase I cancer trials.

I. Tannock, A. Oza, G. Tomlinson, 2013, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Important early advances in squamous cell carcinoma of the head and neck.

I. Braña, L. Siu, É. Bissada, 2012, American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting.

Combination of the mTOR Inhibitor Ridaforolimus and the Anti-IGF1R Monoclonal Antibody Dalotuzumab: Preclinical Characterization and Phase I Clinical Trial

J. Baselga, J. Bendell, I. Braña, 2014, Clinical Cancer Research.

Pembrolizumab alone or with chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: Health-related quality-of-life results from KEYNOTE-048.

R. Greil, K. Harrington, I. Braña, 2022, Oral oncology.

Incidence and characteristics of adverse drug reactions in a cohort of patients treated with PD-1/PD-L1 inhibitors in real-world practice

E. Felip, I. Braña, E. Muñoz-Couselo, 2022, Frontiers in Medicine.

Confounding factors in the assessment of oral mucositis in head and neck cancer

I. Braña, S. Elad, P. Bossi, 2022, Supportive Care in Cancer.

Lurbinectedin, a selective inhibitor of oncogenic transcription, in patients with pretreated germline BRCA1/2 metastatic breast cancer: results from a phase II basket study

G. Shapiro, I. Braña, B. Pistilli, 2022, ESMO open.

Phase I study of the safety and efficacy of INC280 in patients with advanced MET-dependent solid tumors.

D. Nam, Y. Bang, I. Braña, 2014 .

Phase I Trial of Cemiplimab, Radiotherapy, Cyclophosphamide, and Granulocyte Macrophage Colony-Stimulating Factor in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

T. Owonikoko, I. Braña, S. Formenti, 2021 .

Immune profile and outcomes of patients (pts) with gynecological malignancies (GYN) enrolled in early phases immunotherapy (IO) trials.

P. Nuciforo, R. Dienstmann, I. Braña, 2018 .

WEE1 inhibition as anticancer strategy: First advances

H. Mackay, I. Braña, 2014 .

A phase I dose-escalation study of the safety, pharmacokinetics (PK), and pharmacodynamics of XL765 (SAR245409), a PI3K/TORC1/TORC2 inhibitor administered orally to patients (pts) with advanced malignancies.

J. Baselga, E. Heath, P. LoRusso, 2010 .

A phase Ib combination study of RO4929097, a gamma-secretase inhibitor, and temsirolimus in patients with advanced solid tumors

A. Oza, B. Clarke, H. Hirte, 2013, Investigational New Drugs.

Relative bioavailability of three formulations of galunisertib administered as monotherapy in patients with advanced or metastatic cancer

J. Seoane, I. Braña, M. Mitchell, 2016, Drugs in context.

Locally advanced head and neck squamous cell cancer: treatment choice based on risk factors and optimizing drug prescription.

I. Braña, L. Siu, I Brana, 2012, Annals of oncology : official journal of the European Society for Medical Oncology.

Exploring the Immunogenicity of Noncanonical HLA-I Tumor Ligands Identified through Proteogenomics

J. Gartner, Florian Erhard, I. Braña, 2022, bioRxiv.

Clinical development of phosphatidylinositol 3-kinase inhibitors for cancer treatment

I. Braña, L. Siu, 2012, BMC Medicine.

Durvalumab for recurrent or metastatic head and neck squamous cell carcinoma: Results from a single-arm, phase II study in patients with ≥25% tumour cell PD-L1 expression who have progressed on platinum-based chemotherapy.

A. Jimeno, M. Fenton, I. Braña, 2019, European journal of cancer.

Antitumor Activity of Lurbinectedin, a Selective Inhibitor of Oncogene Transcription, in Patients with Relapsed Ewing Sarcoma: Results of a Basket Phase II Study

G. Shapiro, I. Braña, A. Awada, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

Integrated data review of the first-in-human dose (FHD) study evaluating safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the oral transforming growth factor-beta (TGF-ß) receptor I kinase inhibitor, LY2157299 monohydrate (LY).

J. Baselga, J. Seoane, M. Carducci, 2013 .

PD‐1 Blockade with Cemiplimab in Advanced Cutaneous Squamous‐Cell Carcinoma

A. Hauschild, D. Schadendorf, C. Chung, 2018, The New England journal of medicine.

Angiosarcoma of the ovary: is it always a lethal disease?

I. Braña, C. Serrano, A. Oaknin, 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Carlumab, an anti-C-C chemokine ligand 2 monoclonal antibody, in combination with four chemotherapy regimens for the treatment of patients with solid tumors: an open-label, multicenter phase 1b study

J. Tabernero, P. LoRusso, I. Braña, 2015, Targeted Oncology.

Phase I Trial of Cemiplimab, Radiotherapy, Cyclophosphamide, and GM-CSF in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.

T. Owonikoko, I. Lowy, K. Papadopoulos, 2021, The oncologist.

A CT-based Radiomics Signature Is Associated with Response to Immune Checkpoint Inhibitors in Advanced Solid Tumors.

C. Rubio-Perez, J. Carles, E. Felip, 2021, Radiology.

Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study

R. Greil, I. Braña, A. Psyrri, 2022, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

First-in-Human Dose Study of the Novel Transforming Growth Factor-β Receptor I Kinase Inhibitor LY2157299 Monohydrate in Patients with Advanced Cancer and Glioma

J. Baselga, J. Seoane, M. Carducci, 2014, Clinical Cancer Research.

Support systems to guide clinical decision-making in precision oncology: The Cancer Core Europe Molecular Tumor Board Portal

S. Fröhling, J. Lindberg, J. Bergh, 2020, Nature Medicine.

Novel combinations of PI3K-mTOR inhibitors with dacomitinib or chemotherapy in PTEN-deficient patient-derived tumor xenografts

B. Clarke, B. Neel, M. Tsao, 2017, Oncotarget.

Tipifarnib in Head and Neck Squamous Cell Carcinoma With HRAS Mutations

Sung-Bae Kim, K. Harrington, M. Ahn, 2021, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Safety and Efficacy of Durvalumab With or Without Tremelimumab in Patients With PD-L1–Low/Negative Recurrent or Metastatic HNSCC: The Phase 2 CONDOR Randomized Clinical Trial

I. Braña, L. Siu, J. Gilbert, 2019, JAMA oncology.

Phase I dose-escalation and -expansion study of buparlisib (BKM120), an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors

J. Bendell, I. Braña, L. Siu, 2014, Investigational New Drugs.

Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial

B. Monk, D. Solit, F. Meric-Bernstam, 2019, Gynecologic oncology.

Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of SAR245408 (XL147), an Oral Pan-Class I PI3K Inhibitor, in Patients with Advanced Solid Tumors

Jordi Rodon, Irene Braña, J. Baselga, 2013, Clinical Cancer Research.

Efficacy and safety of lurbinectedin and doxorubicin in relapsed small cell lung cancer. Results from an expansion cohort of a phase I study

I. Braña, V. Moreno, M. Forster, 2021, Investigational New Drugs.

A Comprehensive Biomarker Analysis of Microsatellite Unstable/Mismatch Repair Deficient Colorectal Cancer Cohort Treated with Immunotherapy

R. Salazar, J. Tabernero, P. Nuciforo, 2022, International journal of molecular sciences.

Phase I trial of the first-in-class EGFR antibody mixture, Sym004, in patients with advanced solid tumors.

A. Tolcher, R. Dienstmann, D. Rasco, 2011, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Genomic and transcriptomic profiling expands precision cancer medicine: the WINTHER trial

J Jack Lee, Eitan Rubin, Razelle Kurzrock, 2019, Nature Medicine.

First-in-Human Study of PF-05212384 (PKI-587), a Small-Molecule, Intravenous, Dual Inhibitor of PI3K and mTOR in Patients with Advanced Cancer

G. Shapiro, J. Tabernero, E. Kwak, 2015, Clinical Cancer Research.

Toxicity as a biomarker of efficacy of molecular targeted therapies: focus on EGFR and VEGF inhibiting anticancer drugs.

Rodrigo Dienstmann, Jordi Rodon, Irene Braña, 2011, The oncologist.

LIF regulates CXCL9 in tumor-associated macrophages and prevents CD8+ T cell tumor-infiltration impairing anti-PD1 therapy

C. Rubio-Perez, J. Sahuquillo, J. Tabernero, 2019, Nature Communications.

Initial results from a dose finding study of TNO155, a SHP2 inhibitor, in adults with advanced solid tumors.

G. Shapiro, Melissa L. Johnson, S. Moody, 2021 .

Pharmacokinetic, pharmacodynamic and biomarker evaluation of transforming growth factor-β receptor I kinase inhibitor, galunisertib, in phase 1 study in patients with advanced cancer

J. Baselga, J. Seoane, M. Carducci, 2014, Investigational New Drugs.

Cardiotoxicity.

J. Tabernero, I. Braña, J. Tabernero, 2010, Annals of oncology : official journal of the European Society for Medical Oncology.

LIF regulates CXCL9 in tumor-associated macrophages and prevents CD8+ T cell tumor-infiltration impairing anti-PD1 therapy

C. Rubio-Perez, J. Sahuquillo, J. Tabernero, 2019, Nature Communications.

Evolving Landscape of Molecular Prescreening Strategies for Oncology Early Clinical Trials

J. Carles, E. Felip, P. Nuciforo, 2020, JCO precision oncology.

First-in-human Phase 1 open label study of the BET inhibitor ODM-207 in patients with selected solid tumours

R. Plummer, A. Snapir, I. Braña, 2020, British Journal of Cancer.

A parallel-arm phase I trial of the humanised anti-IGF-1R antibody dalotuzumab in combination with the AKT inhibitor MK-2206, the mTOR inhibitor ridaforolimus, or the NOTCH inhibitor MK-0752, in patients with advanced solid tumours

R. Berger, J. Edenfield, W. Dalton, 2014, British Journal of Cancer.

Antitumour activity of neratinib in patients with HER2-mutant advanced biliary tract cancers

M. Berger, S. Loi, J Zhang, 2023, Nature Communications.

Phase I study of CC-90010, a reversible, oral BET inhibitor in patients with advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma.

I. Braña, M. Zuraek, I. Aronchik, 2020, Annals of oncology : official journal of the European Society for Medical Oncology.

Phase 1 Study of Molibresib (GSK525762), a Bromodomain and Extra-Terminal Domain Protein Inhibitor, in NUT Carcinoma and Other Solid Tumors

G. Shapiro, R. Prinjha, I. Braña, 2019, JNCI cancer spectrum.

Safety and clinical activity of atezolizumab in head and neck cancer: results from a phase I trial

L. Molinero, F. Kabbinavar, I. Braña, 2018, Annals of oncology : official journal of the European Society for Medical Oncology.

Head and neck cancer surgery during the COVID‐19 pandemic: An international, multicenter, observational cohort study

R. Shaw, A. Agarwal, T. Poli, 2020, Cancer.

Cemiplimab (REGN2810): A fully human anti-PD-1 monoclonal antibody for patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC)—Initial safety and efficacy from expansion cohorts (ECs) of phase I study.

Melissa L. Johnson, T. Owonikoko, I. Lowy, 2017 .

A phase I trial of pantoprazole in combination with doxorubicin in patients with advanced solid tumors: evaluation of pharmacokinetics of both drugs and tissue penetration of doxorubicin

I. Tannock, I. Braña, L. Siu, 2014, Investigational New Drugs.

The Molecular Tumor Board Portal supports clinical decisions and automated reporting for precision oncology

S. Fröhling, J. Lindberg, J. Bergh, 2022, Nature Cancer.

Implementation of a Clinical Decision Support System for Precision Oncology across an Academic Network

David Tamborero, Carlos Caldas, Giovanni Apolone, 2021 .

New clinical trial designs in the era of precision medicine

J. Tabernero, R. Dienstmann, I. Braña, 2019, Molecular oncology.

BET inhibitor trotabresib in heavily pretreated patients with solid tumors and diffuse large B-cell lymphomas

A. Italiano, I. Braña, I. Aronchik, 2023, Nature Communications.

PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer.

I. Lowy, K. Papadopoulos, I. Braña, 2020, Gynecologic oncology.

Phase I, first-in-human study of MSC-1 (AZD0171), a humanized anti-leukemia inhibitory factor monoclonal antibody, for advanced solid tumors

A. Schram, I. Braña, P. Vickers, 2022, ESMO open.

KEYNOTE-689: Phase 3 study of adjuvant and neoadjuvant pembrolizumab combined with standard of care (SOC) in patients with resectable, locally advanced head and neck squamous cell carcinoma.

N. Lee, W. Westra, I. Braña, 2019, Journal of Clinical Oncology.

Artificial intelligence combining radiomics and clinical data for predicting response to immunotherapy

J. Carles, E. Felip, J. Tabernero, 2019, Annals of Oncology.

Nutritional status associates with immunotherapy clinical outcomes in recurrent or metastatic head and neck squamous cell carcinoma patients.

E. Felip, R. Dienstmann, I. Braña, 2023, Oral oncology.

A first-in-human phase I trial of LY2780301, a dual p70 S6 kinase and Akt Inhibitor, in patients with advanced or metastatic cancer

M. Hidalgo, I. Braña, P. López-Casas, 2015, Investigational New Drugs.

Response to "Analysis of the association between prospectively collected immune-related adverse events and survival in patients with solid tumor treated with immune-checkpoint blockers, taking into account immortal-time bias".

R. Dienstmann, I. Braña, O. Mirallas, 2022, Cancer treatment reviews.

Targeting HER2 mutation–positive advanced biliary tract cancers with neratinib: Final results from the phase 2 SUMMIT basket trial.

M. Berger, S. Loi, D. Solit, 2022, Journal of Clinical Oncology.

Support systems to guide clinical decision-making in precision oncology: The Cancer Core Europe Molecular Tumor Board Portal

S. Fröhling, J. Lindberg, J. Bergh, 2020, Nature Medicine.

Phase I/II sequencing study of azacitidine, epacadostat, and pembrolizumab in advanced solid tumors

R. Kurzrock, M. Fakih, J. Bendell, 2023, British Journal of Cancer.

Digital Display Precision Predictor: the prototype of a global biomarker model to guide treatments with targeted therapy and predict progression-free survival

N. Girard, R. Schilsky, R. Berger, 2021, npj Precision Oncology.

The oral transforming growth factor-beta (TGF-ß) receptor I kinase inhibitor LY2157299 plus lomustine in patients with treatment-refractory malignant glioma: The first human dose study.

J. Baselga, J. Seoane, M. Carducci, 2012 .

First human dose (FHD) study of the oral transforming growth factor-beta receptor I kinase inhibitor LY2157299 in patients with treatment-refractory malignant glioma.

J. Baselga, J. Seoane, M. Carducci, 2011, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Treating HER2-mutant advanced biliary tract cancer with neratinib: benefits of HER2-directed targeted therapy in the phase 2 SUMMIT 'basket' trial.

S. Loi, D. Solit, G. Shapiro, 2019, Annals of oncology : official journal of the European Society for Medical Oncology.

Absence of Relationship between Mitochondrial DNA Haplogroups and Cisplatin-Induced Hearing Loss

I. Braña, A. Lyakhovich, M. Lleonart, 2017, International journal of otolaryngology.

A phase Ib/II study (SCORES) of durvalumab (D) plus danvatirsen (DAN; AZD9150) or AZD5069 (CX2i) in advanced solid malignancies and recurrent/metastatic head and neck squamous cell carcinoma (RM-HNSCC): Updated results.

K. Harrington, I. Braña, D. Hong, 2018, Annals of Oncology.

537MO First-in-human study of JNJ-64619178, a protein arginine methyltransferase 5 (PRMT5) inhibitor, in patients with advanced cancers

J. Infante, I. Braña, V. Moreno, 2020 .

A pan-cancer clinical platform to predict immunotherapy outcomes and prioritize immuno-oncology combinations in early-phase trials.

Benjamin Haibe-Kains, T. Pugh, E. Felip, 2023, Med.

Incidence and clinical implications of a new definition of hyperprogression (HPD) with immune checkpoint inhibitors (ICIs) in patients treated in phase 1 (Ph1) trials.

E. Felip, J. Tabernero, R. Dienstmann, 2018 .

First-in-Human Dose Study of the Novel Transforming Growth Factor-β Receptor I Kinase Inhibitor LY2157299 Monohydrate in Patients with Advanced Cancer and Glioma

J. Baselga, J. Seoane, L. Paz-Ares, 2014, Clinical Cancer Research.

First-in-Human Study of PF-05212384 (PKI-587), a Small-Molecule, Intravenous, Dual Inhibitor of PI3K and mTOR in Patients with Advanced Cancer

G. Shapiro, J. Tabernero, E. Kwak, 2015, Clinical Cancer Research.

Public and patient involvement: a survey on knowledge, experience and opinions among researchers within a precision oncology European project

Katherine E. Honan, S. Fröhling, R. Schlenk, 2023, BMC Cancer.

Abstract PR08: Preliminary results from a phase 2 trial of tipifarnib in squamous cell carcinomas (SCCs) with HRAS mutations

Sung-Bae Kim, K. Harrington, M. Ahn, 2019, Clinical Trials.

Abstract LB-A10: Preliminary results from a phase 2 proof of concept trial of tipifarnib in tumors with HRAS mutations

A. Ho, I. Braña, A. Gualberto, 2018 .

Targeting HER2 (ERBB2) mutation-positive advanced biliary tract cancers with neratinib: Results from the phase II SUMMIT ‘basket’ trial.

S. Loi, J Zhang, M. Borad, 2021 .

1044OLong-Term Safety and Clinical Outcomes of Atezolizumab in Head and Neck Cancer: Phase Ia Trial Results

F. Hodi, L. Molinero, I. Braña, 2017 .

Angiosarcoma of the ovary: is it always a lethal disease?

I. Braña, C. Serrano, A. Oaknin, 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

Relative bioavailability of three formulations of galunisertib administered as monotherapy in patients with advanced or metastatic cancer

J. Seoane, I. Braña, M. Mitchell, 2016, Drugs in context.

1058PDoes hyper-progression exist among head and neck cancer patients treated with immunotherapy?

M. Plana, I. Braña, A. Franco, 2017 .

Results from a phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with PD-L1 unselected metastatic second-line squamous head and neck carcinoma.

I. Braña, M. Forster, M. Krebs, 2021 .