Early surgical safety outcomes from PURE-01: Secondary analysis from a phase 2 open-label study of neoadjuvant pembrolizumab (pembro) before radical cystectomy for muscle-invasive urothelial bladder carcinoma (MIUC)

A. Briganti; A. Necchi; D. Raggi; P. Giannatempo; M. Bianchi; M. Freschi; M. Colecchia; N. Fossati; G. Gandaglia; A. Salonia; R. Salvioni; R. Colombo; A. Gallina; F. Montorsi

doi:10.1016/s1569-9056(18)31211-9

Early surgical safety outcomes from PURE-01: Secondary analysis from a phase 2 open-label study of neoadjuvant pembrolizumab (pembro) before radical cystectomy for muscle-invasive urothelial bladder carcinoma (MIUC)

European Urology Supplements ◽

10.1016/s1569-9056(18)31211-9 ◽

2018 ◽

Vol 17 (2) ◽

pp. e523-e524 ◽

Cited By ~ 1

Author(s):

A. Briganti ◽

A. Necchi ◽

D. Raggi ◽

P. Giannatempo ◽

M. Bianchi ◽

...

Keyword(s):

Bladder Carcinoma ◽

Secondary Analysis ◽

Phase 2 ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Surgical Safety ◽

Urothelial Bladder Carcinoma ◽

Urothelial Bladder ◽

Muscle Invasive

PD11-11 INTERIM RESULTS FROM PURE-01: A PHASE 2, OPEN-LABEL STUDY OF NEOADJUVANT PEMBROLIZUMAB (PEMBRO) BEFORE RADICAL CYSTECTOMY FOR MUSCLE-INVASIVE UROTHELIAL BLADDER CARCINOMA (MIUC)

The Journal of Urology ◽

10.1016/j.juro.2018.02.634 ◽

2018 ◽

Vol 199 (4S) ◽

Author(s):

Andrea Necchi ◽

Alberto Briganti ◽

Daniele Raggi ◽

Patrizia Giannatempo ◽

Marco Bianchi ◽

...

Keyword(s):

Radical Cystectomy ◽

Bladder Carcinoma ◽

Phase 2 ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Urothelial Bladder Carcinoma ◽

Urothelial Bladder ◽

Muscle Invasive

PURE01: An open label, single-arm, phase 2 study of the anti-programmed death (PD)-1 monoclonal antibody (moAb) pembrolizumab for neoadjuvant therapy of muscle-invasive urothelial bladder carcinoma (miUBC)

Annals of Oncology ◽

10.1093/annonc/mdw373.74 ◽

2016 ◽

Vol 27 ◽

pp. vi294

Author(s):

A. Necchi ◽

L. Mariani ◽

A. Anichini ◽

P. Giannatempo ◽

D. Raggi ◽

...

Keyword(s):

Monoclonal Antibody ◽

Neoadjuvant Therapy ◽

Bladder Carcinoma ◽

Phase 2 ◽

Open Label ◽

Urothelial Bladder Carcinoma ◽

Programmed Death ◽

Phase 2 Study ◽

Urothelial Bladder ◽

Muscle Invasive

Pembrolizumab as Neoadjuvant Therapy Preceding Radical Cystectomy in Patients with Muscle-Invasive Urothelial Bladder Carcinoma (PURE-01): An Open-Label, Single-Group, Phase 2 Study

SSRN Electronic Journal ◽

10.2139/ssrn.3225486 ◽

2018 ◽

Cited By ~ 3

Author(s):

Andrea Necchi ◽

Andrea Anichini ◽

Daniele Raggi ◽

Alberto Briganti ◽

Simona Massa ◽

...

Keyword(s):

Neoadjuvant Therapy ◽

Radical Cystectomy ◽

Bladder Carcinoma ◽

Phase 2 ◽

Single Group ◽

Open Label ◽

Urothelial Bladder Carcinoma ◽

Phase 2 Study ◽

Urothelial Bladder ◽

Muscle Invasive

Neoadjuvant sorafenib, gemcitabine, and cisplatin administration preceding cystectomy in patients with muscle-invasive urothelial bladder carcinoma: An open-label, single-arm, single-center, phase 2 study

Urologic Oncology Seminars and Original Investigations ◽

10.1016/j.urolonc.2017.08.020 ◽

2018 ◽

Vol 36 (1) ◽

pp. 8.e1-8.e8 ◽

Cited By ~ 4

Author(s):

Andrea Necchi ◽

Salvatore Lo Vullo ◽

Daniele Raggi ◽

Federica Perrone ◽

Patrizia Giannatempo ◽

...

Keyword(s):

Bladder Carcinoma ◽

Phase 2 ◽

Single Center ◽

Open Label ◽

Urothelial Bladder Carcinoma ◽

Phase 2 Study ◽

Urothelial Bladder ◽

Muscle Invasive ◽

Gemcitabine And Cisplatin

PURE01: An open label, single-arm, phase 2 study of the anti-programmed death (PD)-1 monoclonal antibody (moAb) pembrolizumab for neoadjuvant therapy of muscle-invasive urothelial bladder carcinoma (miUBC)

European Urology Supplements ◽

10.1016/s1569-9056(17)30277-4 ◽

2017 ◽

Vol 16 (3) ◽

pp. e365-e366

Author(s):

A. Necchi ◽

L. Mariani ◽

A. Anichini ◽

P. Giannatempo ◽

D. Raggi ◽

...

Keyword(s):

Monoclonal Antibody ◽

Neoadjuvant Therapy ◽

Bladder Carcinoma ◽

Phase 2 ◽

Open Label ◽

Urothelial Bladder Carcinoma ◽

Programmed Death ◽

Phase 2 Study ◽

Urothelial Bladder ◽

Muscle Invasive

Faculty Opinions recommendation of Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Urothelial Bladder Carcinoma (PURE-01): An Open-Label, Single-Arm, Phase II Study.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.734259396.793578102 ◽

2020 ◽

Author(s):

Matthew Milowsky

Keyword(s):

Neoadjuvant Therapy ◽

Radical Cystectomy ◽

Phase Ii ◽

Bladder Carcinoma ◽

Phase Ii Study ◽

Open Label ◽

Urothelial Bladder Carcinoma ◽

Urothelial Bladder ◽

Muscle Invasive

Preoperative pembrolizumab (pembro) before radical cystectomy (RC) for muscle-invasive urothelial bladder carcinoma (MIUC): Interim clinical and biomarker findings from the phase 2 PURE-01 study.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.15_suppl.4507 ◽

2018 ◽

Vol 36 (15_suppl) ◽

pp. 4507-4507 ◽

Cited By ~ 13

Author(s):

Andrea Necchi ◽

Alberto Briganti ◽

Marco Bianchi ◽

Daniele Raggi ◽

Patrizia Giannatempo ◽

...

Keyword(s):

Radical Cystectomy ◽

Bladder Carcinoma ◽

Phase 2 ◽

Urothelial Bladder Carcinoma ◽

Urothelial Bladder ◽

Muscle Invasive

Re: Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients with Muscle-invasive Urothelial Bladder Carcinoma (PURE-01): An Open-label, Single-arm, Phase II Study

European Urology ◽

10.1016/j.eururo.2018.12.034 ◽

2019 ◽

Vol 75 (4) ◽

pp. 695-696 ◽

Cited By ~ 1

Author(s):

Kilian M. Gust ◽

Shahrokh F. Shariat

Keyword(s):

Neoadjuvant Therapy ◽

Radical Cystectomy ◽

Phase Ii ◽

Bladder Carcinoma ◽

Phase Ii Study ◽

Open Label ◽

Urothelial Bladder Carcinoma ◽

Urothelial Bladder ◽

Muscle Invasive

Open-label randomized multi-center phase 2 study: gemcitabine cisplatin plus avelumab or gemcitabine cisplatin as first-line treatment of patients with locally advanced or metastatic urothelial bladder carcinoma: GCisAve

Bulletin du Cancer ◽

10.1016/s0007-4551(20)30280-0 ◽

2020 ◽

Vol 107 (5) ◽

pp. eS1-eS7

Author(s):

Marine Gross-Goupil ◽

Charlotte Domblides ◽

Felix Lefort ◽

Alain Ravaud

Keyword(s):

Bladder Carcinoma ◽

Locally Advanced ◽

Line Treatment ◽

Phase 2 ◽

First Line ◽

Open Label ◽

Urothelial Bladder Carcinoma ◽

Phase 2 Study ◽

Urothelial Bladder ◽

First Line Treatment

Faculty Opinions recommendation of Neridronate improves bone mineral density and reduces back pain in β-thalassaemia patients with osteoporosis: results from a phase 2, randomized, parallel-arm, open-label study.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.717797810.793153212 ◽

2012 ◽

Author(s):

Klaus Klaushofer

Keyword(s):

Bone Mineral Density ◽

Back Pain ◽

Bone Mineral ◽

Phase 2 ◽

Mineral Density ◽

Open Label ◽

Open Label Study ◽

Label Study