Urologic Oncology Program


Board

Pr. Arnaud Mejean
Surgeon
Pr. Nicolas Barry Delongchamps
Surgeon
Pr. Jérome Alexandre
Physician


Steering Committee

Pr. Eric Tatour - Immunologist
Pr. Marc Olivier Timsit - Surgeon
Pr. Laure Fournier - Radiologist
Dr. Virginie Verkarre - Pathologist
Pr. Anne Paule Gimenez - Genetic
Dr. Sarah Kreps - Radiotherapist
Pr. Hélène Blons - Biologist
Pr. Francois Goldwasser - Physician
Pr. Jean Michel Correas - Radiologist
Dr. Benoit Blanchet- Pharmacologist
Dr. Yann-Alexandre Vano - Physician
Pr. Catherine Sautes Fridman - Immunologist
Dr. Constance Thibault - Physician
Dr. Olivier Huillard - Physician
Pr. Dominique Helley - Biologist
Pr. Jerome Galon - Immunologist

Paris Cancer Institute: CARPEM has a strong activity in uro-oncology and involves 3 departments of APHP.Centre (Hematology and Oncology department, Imaging, Nuclear Medicine and Pathology department and Biology, Physiology and Genomic Medicine department). It is the most important surgical center dedicated to uro-oncology tumor in the Great Paris with national and international expertise in prostate, bladder and kidney tumors. Specifically, 28 beds in urology are dedicated to uro-oncology. This program took in charge 2995 new cases of prostate, kidney, bladder cancers during the last 3 years (see table 2), 1339 new cases of urological tumors have been surgically removed during the last 3 years and 2415 cycles of chemotherapy/immunotherapy have been performed (for detail see annex 1). It involves 2 sites of the APHP.Centre (Pompidou and Cochin hospitals) with very similar organization with both medical and surgery strengths. Furthermore, a dedicated genetic counselling is proposed for patients in case of suspicion of Von Hippel Lindau disease, Birt-Hogg-Dubé syndrome, etc…. One hundred patients and their relatives are addressed to this consultation each year for suspicion of hereditary renal cancers. All these clinical activities are structured around 2 weekly cancer multidisciplinary team meetings. These meetings follow the INCA national guidelines, and ESMO guidelines.

This program developed intensive clinical and translational research in broad fields from surgery to personalized medicine. A strong expertise in the clinical care of metastatic kidney disease from surgery to immunotherapy has been acquired during last years. A first trial based on genomic characterization of kidney cancers has been launched (BIONIKK trial). The program developed also an expertise in robotic prostatic surgery and on focal treatment modalities as well as in personalized medicine and immunotherapy in bladder cancer.

Clinical research

Clinical research is developed according to 2 axes (clinical interventional trial and surgery) with strong commitment of both medical physicians and surgeons. In the following section we will highlight the major successes in medical and surgical innovation in treatment of urologic cancers of 2018. In a nutshell 37 clinical trials are open to inclusion (22 phase III, 15 phase Ib/II) see annex 2. Twelve are dedicated to prostate cancer, 14 are dedicated to bladder cancer and 11 are dedicated to renal cancer.

Prostate Cancers

Recent studies on chemotherapy and new hormonal therapies in prostate cancers were conducted and have shown the lack of treatment efficacy of hormonal therapy combo or alone or with docetaxel in patients with rising PSA and hormone sensitive (Oudard S et al, JAMA Oncol 2019). We also led a large European retrospective study based on CATS registry showing that clinical progression in metastatic castration-resistant prostate cancer patients is associated with poor outcomes as compared to prostate-specific antigen or radiological only progression (Delanoy N et al, Eur J Cancer 2019). We participated to the phase 3 SPARTAN trial to evaluate the effect of apalutamide on metastasis-free survival in nonmetastatic castration-resistant prostate cancer and a PSA doubling time of 10 months or less showing metastasis-free survival and time to symptomatic progression were significantly longer with apalutamide than with placebo (Smith MR et al, New Engl J Med  2018).

Concerning surgery, we focused our research on focal treatment modalities. Prof. N. Barry Delongchamps set up the FOSTINE trial (NCT03023345) which is a “first-in-man” pilot study evaluating microwave focal ablation, delivered through a trans-rectal approach, with organ-based tracking image fusion. The main endpoint was reached in 8 among the 10 patients already treated (80%) with no reported adverse event after one-year follow-up. A multicentric European trial coordinated by Prof. N. Barry Delongchamps, will start in December 2019. Primary endpoint will be the absence of tumor within the treated area at 1 year.

Renal, Urothelial and Bladder cancers

Pr. A Mejean led an international phase III trial in metastatic renal carcinoma demonstrating the non-inferiority of the sunitinib arm as compared to the nephrectomy-sunitinib arm with regard to overall survival. No significant differences in response rate or progression-free survival was observed (Méjean A et al, New Engl J Med 2018).

NEMIO design

Set-up by our group, we are conducting 2 phase II trials : BIONIKK trial (NCT02960906) first gene expression based randomized phase II trial in renal cell carcinoma (see research translational section), and NEMIO phase II trial (NCT03549715) testing the combination of chemotherapy with immune checkpoint blocker (ICB) in muscle invasive bladder cancer in neoadjuvant setting (see figure). The first 12 patients have been enrolled from December 2018 and July 2019 and we expect recruitment to be completed in 2021.

Translational research

Our translational research is based both on the characterization of genetic alterations in tumors cells and on the study of tumor microenvironment (immune and endothelial cells). This programinvolves 4 research teams of the SIRIC CARPEM. These research teams are led by E. Tartour, AP. Roqueplo, I. Cremer, and J. Zucman-Rossi. A collaboration was set-up with V.Coffin team at the INEM.

Microenvironment and genomics in clear-cell Renal Cell Carcinoma RCC

BIONIKK design

 

One of the major achievements in the last 5 years is the molecular characterization of the tumor cells and their microenvironment in kidney cancer. A significant contribution has been done to the molecular transcriptomic analysis of RCC within the “Programme Carte d’Identité des Tumeurs” leading by the French League Against Cancer. Based on these characterizations, 4 different RCC groups were identified. These results lead us to set-up the first gene expression based randomized phase II trial in RCC, BIONIKK-1 trial (NCT02960906) testing either tyrosine kinase inhibitors or ICB according to the determination of molecular metastatic RCC subgroups. Two hundred patients were randomized, the last being in July 2019.

We participated to TRACERx Renal program, using combination of whole-genome sequencing analysis and multi-region sampling approach to provide insights into the nature and key oncogenic events in RCC (Mitchell TJ et al, Cell 2018).

Pr. Helley and Dr. Mauge (E. Tartour team at PARCC) conduct a translational program that focuses on the study of the circulating vascular compartment including mature or progenitor circulating endothelial cells, and plasma factors related to angiogenesis. They assessed the role of plasma biomarkers to predict the response to antiangiogenic treatments in 2 clinical trials including patients with renal and prostate cancer. They showed in PREINSUT phase II trial (NCT00930345) that biomarkers associated with primary renal tumor size change under sunitinib treatment were stromal cell-derived factor-1 (SDF1) and platelet-derived growth factor (PDGF) (Mauge L et al, Clin Cancer Res 2018).

Dr Burnichon, Dr Favier, Dr Verkarre and Pr Timsit (J Favier & AP Roqueplo Team) are developing a program dedicated to rare RCC. Based on their former studies on integrative genomic characterization of pheochromocytoma and paraganglioma that led to the identification of new therapeutic targets and biomarkers (Job S, Clin Cancer Res, 2019), they built a program dedicated to the molecular profiling of rare subtypes of kidney tumors. Their main objective is the identification of carcinogenesis pathways involved in the different rare RCC subtypes and their relevance for targeted therapy. Chromophobe RCCs are currently extensively studied.

Based on 2 different studies PREINSUT and BIONIKK, Pr. L. Fournier (B. Tavitian team) developed a radiomics approach in RCC. A radiomic signature that differentiated two groups of patients with very different outcomes in terms of PFS (1.4 vs. 16.1 months, p = 0.0075) and OS (5.6 vs 29.2 months; p = 1.78.10-5) was identified. Confirmation of these results is being analyzed on an independent validation population from the BIONIKK study.

Stem cell studies in prostate cancers

The team of V. Goffin uses various preclinical models and clinical samples to understand the molecular and cellular bases of prostate cancer resistance to castration. The team recently identified stem/progenitor cells that resist castration and promote cancer recurrence. Current researches aim to identify clinically relevant biomarkers of these castration-resistant primitive cells and actionable pathways to eradicate them.

All these research areas are developed in programs 1 and 2 of the SIRIC CARPEM.

The Urologic cancer Program integrates 20 residents and 18 fellows each year. Weekly dedicated internal seminars are organized on both sites.

Medical and surgical teams are widely involved in the university teaching of urologic pathologies in University of Paris and in several national teaching degrees/master’s degrees in the field of oncology :

  • Inter University Diploma in urology oncology coordinated by Albiges L & Fizazi K from Paris Diderot University & Mejean A & Oudard S from University of Paris
  • University Diploma on therapeutic immunology from Paris Descartes : W.H. Fridman, F Pages, E Tartour
  • Master 2 in clinical oncology: Prs F Goldwasser, J Alexandre & S Oudard
  • Surgery diploma of urology at the University of Paris
  • ILLUMENS on animals (Prs Mejean & Timsit)
  • Urology diploma (ECU, Pr Mejean)
  • Master in oncology on Targeted therapies and Checkpoint inhibitors (Prs JY Pierga, J Alexandre & S Oudard).

Based on our skillness we would like to

  • Increase the rate of inclusion in trials to 15% of all patients with urological cancer of less than 75 years old
  • Implement prostate cancer screening and developing in parallel focal treatment
  • Reinforce translational research activities, by focusing on microenvironment and biomarkers of response to immunotherapies in bladder and kidney cancers.
  • Develop our expertise in translational research on rare tumors: adrenal tumors, neuroendocrine prostate and bladder cancers, Bellini and medullary kidney cancer and joint this effort with the national France Genomics 2025 program dedicated to whole genome sequencing of rare cancers
  • Develop a translational research on prostate cancer by applying to an emergent research grant to the SIRIC CARPEM
Name Title Speciality Clinical/Research Unit Resarch Team / Hospital
StŽphane Oudard Full Prof Oncologist PARCC U970 Immunotherapy and anti-angiogenic therapy in oncology
Arnaud Mejean Full Prof Surgeon Departmenf of Urology HEGP hospital
Michael Peyromaure Full Prof Surgeon Departmenf of Urology Cochin hospital
JŽr™me Alexandre Full Prof Oncologist UMRS 1138 Cordeliers Personalized medecine therapeutic optimization
Nicolas Barry de Longchamps Full Prof Surgeon U1151 PRL/GH Pathophysiology
Eric Tartour Full physician Immunologist PARCC U970 Personalized medecine therapeutic optimization
Marc Olivier Timsit Full Prof Surgeon PARCC U970 Genetics and Metabolism of Rare Cancers
Laure Fournier Full Prof Radiologist INSERM UMR-S970 Cardiovascular Research Center
Virginie Verkarre Full time physician Pathologist PARCC U970 Genetics and Metabolism of Rare Cancers
Sibony Mathilde Full Prof Pathologist
Anne Paule Gimenez Full Prof Genetic PARCC U970 Equipe GŽnŽtique et MŽtabolisme des cancers rares
Sarah Kreps Full time physician Radiation therapist INSERM UMR 1138 Team 22 Information Sciences to support Personalized Medicine,
Francois Goldwasser Full Prof Oncologist EA 4466 PRETRAM, Pharmacy Faculty CAncer Research for PErsonalized Medicine (CARPEM),
Benoit Blanchet Full time physician Pharmacologist Inserm U1268, CiTCom UMR8038 CNRS, Pharmacokinetics and Pharmacochemistry Unit
JŽr™me Galon Full time physician Biologist Inserm U1138 Laboratory of Integrative Cancer Immunology
JŽr™me Batteux Full time physician Biologist Inserm U1268, CiTCom UMR8038 CNRS, Pharmacokinetics and Pharmacochemistry Unit
Jean Michel Correas Full Prof Radiologist CNRS UMR 7587, INSERM ERL U-979, Institut Langevin, ESPCI Paris, PSL Research University
Yann-Alexandre Vano Full time physician Oncologist INSERM1138 Inflammation, complement and cancer,
Catherine Sautes Fridman Full Prof Immunologist INSERM1138 Inflammation, complement and cancer team
HervŽ Fridman Full Prof Immunologist INSERM1138 Inflammation, complement and cancer team
Olivier Huillard Full time physician Oncologist EA 4466 PRETRAM, Pharmacy Faculty CAncer Research for PErsonalized Medicine (CARPEM),
Francois Audenet Full time physician Surgeon Departmenf of Urology EGP hospital
Charles Dariane Full Prof Surgeon Departmenf of Urology EGP hospital
Vincent Goffin Research Director Inserm Basic Research INEM U1151 PRL/GH Pathophysiology: Translational Approaches
Laetitia Mauge Full time physician Biologist PARCC U970 Personalized medecine therapeutic optimization
Burnichon Nelly Associated Prof Molecular Genetics PARCC U970 Genetics and Metabolism of Rare Cancers
Favier Judith Research director Biologist PARCC U970 Genetics and Metabolism of Rare Cancers
Bastien Rance Full Prof Biomedical Informatics INSERM 1138 Information science to support personalized medicine

The selected following publications highlight the strength of clinical and translational research developed in the urologic program:

  1. Carton E, Noe G, Huillard O, Golmard L, Giroux J, Cessot A, Saidu NE, Peyromaure M, Zerbib M, Narjoz C, Guibourdenche J, Thomas A, Vidal M, Goldwasser F, Blanchet B, Alexandre J. Relation between plasma trough concentration of abiraterone and prostate-specific antigen response in metastatic castration-resistant prostate cancer patients. Eur J Cancer. 2017;72:54–61.
  2. Clément-Zhao A, Auvray M, Aboudagga H, Blanc-Durand F, Angelergues A, Vano YA, Mercier F, El Awadly N, Verret B, Thibault C, Oudard S. Safety and efficacy of 2-weekly cabazitaxel in metastatic castration-resistant prostate cancer. BJU Int. 2018;121:203-208.
  3. Oudard S, Latorzeff I, Caty A, Miglianico L, Sevin E, Hardy-Bessard AC, Delva R, Rolland F, Mouret L, Priou F, Beuzeboc P, Gravis G, Linassier C, Gomez P, Voog E, Muracciole X, Abraham C, Banu E, Ferrero JM, Ravaud A, Krakowski I, Lagrange JL, Deplanque G, Zylberait D, Bozec L, Houede N, Culine S, Elaidi R. Effect of Adding Docetaxel to Androgen-Deprivation Therapy in Patients With High-Risk Prostate Cancer With Rising Prostate-Specific Antigen Levels After Primary Local Therapy: A Randomized Clinical Trial. JAMA Oncol. 2019;5:623-32.
  4. Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, Olmos D, Mainwaring PN, Lee JY, Uemura H, Lopez-Gitlitz A, Trudel GC, Espina BM, Shu Y, Park YC, Rackoff WR, Yu MK, Small EJ; SPARTAN Investigators. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018;378:1408-1418.
  5. Delanoy N, Hardy-Bessard AC, Efstathiou E, Le Moulec S, Basso U, Birtle A, Thomson A, Krainer M, Guillot A, De Giorgi U, Hasbini A, Daugaard G, Bahl A, Chowdhury S, Caffo O, Beuzeboc P, Spaeth D, Eymard JC, Fléchon A, Alexandre J, Helissey C, Butt M, Priou F, Lechevallier É, Deville JL, Goupil MG, Morales R, Thiery-Vuillemin A, Gavrikova T, Barthelemy P, Sella A, Fizazi K, Baciarello G, Fererro JM, Laguerre B, Verret B, Hans S, Oudard S. Sequencing of Taxanes and New Androgen-targeted Therapies in Metastatic Castration-resistant Prostate Cancer: Results of the International Multicentre Retrospective CATS Database. Eur Urol Oncol. 2018;1:467-475.
  6. Mauge L, Mejean A, Fournier L, Pereira H, Etienne-Grimaldi MC, Levionnois E, Caty A, Abadie-Lacourtoisie S, Culine S, Le Moulec S, Linassier C, Théodore C, Ravaud A, Albiges L, Grine A, Tartour E, Milano G, Gille AS, Verkarre V, Helley D, Oudard S; PREINSUT study group. Sunitinib Prior to Planned Nephrectomy in Metastatic Renal Cell Carcinoma: Angiogenesis Biomarkers Predict Clinical Outcome in the Prospective Phase II PREINSUT Trial. Clin Cancer Res. 2018;24:5534-5542
  7. Méjean A, Ravaud A, Thezenas S, Colas S, Beauval JB, Bensalah K, Geoffrois L, Thiery-Vuillemin A, Cormier L, Lang H, Guy L, Gravis G, Rolland F, Linassier C, Lechevallier E, Beisland C, Aitchison M, Oudard S, Patard JJ, Theodore C, Chevreau C, Laguerre B, Hubert J, Gross-Goupil M, Bernhard JC, Albiges L, Timsit MO, Lebret T, Escudier B. Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2018;379:417-427
  8. Mitchell TJ, Turajlic S, Rowan A, Nicol D, Farmery JHR, O’Brien T, Martincorena I, Tarpey P, Angelopoulos N, Yates LR, Butler AP, Raine K, Stewart GD, Challacombe B, Fernando A, Lopez JI, Hazell S, Chandra A, Chowdhury S, Rudman S, Soultati A, Stamp G, Fotiadis N, Pickering L, Au L, Spain L, Lynch J, Stares M, Teague J, Maura F, Wedge DC, Horswell S, Chambers T, Litchfield K, Xu H, Stewart A, Elaidi R, Oudard S, McGranahan N, Csabai I, Gore M, Futreal PA, Larkin J, Lynch AG, Szallasi Z, Swanton C, Campbell PJ; TRACERx Renal Consortium.Cell. Timing the Landmark Events in the Evolution of Clear Cell Renal Cell Cancer: TRACERx Renal. Cell 2018 Apr 19;173:611-623.e17.
  9. Job S, Draskovic I, Burnichon N, Buffet A, Cros J, Lépine C, Venisse A, Robidel E, Verkarre V, Meatchi T, Sibony M, Amar L, Bertherat J, de Reyniès A, Londoño-Vallejo A, Favier J, Castro-Vega LJ, Gimenez-Roqueplo AP. Telomerase Activation and ATRX Mutations Are Independent Risk Factors for Metastatic Pheochromocytoma and Paraganglioma. Clin Cancer Res. 2019 Jan 15;25:760-770.
  10. Bernichtein S, Pigat N, Barry Delongchamps N, Boutillon F, Verkarre V, Camparo P, Reyes-Gomez E, Mejean A, Oudard SM, Lepicard EM, Viltard M, Souberbielle JC, Friedlander G, Capiod T, Goffin V. Vitamin D3 prevents calcium-induced progression of early-stage prostate tumors by counteracting TRPC6 and calcium sensing receptor upregulation. Cancer Res. 2017; 77:355-36.
  11. Granier C, Dariane C, Combe P, Verkarre V, Urien S, Badoual C, Roussel H, Mandavit M, Ravel P, Sibony M, Biard L, Radulescu C, Vinatier E, Benhamouda N, Peyromaure M, Oudard S, Mejean A, Timsit MO, Gey A, Tartour E. Tim-3 Expression on Tumor-Infiltrating PD-1+CD8+ T Cells Correlates with Poor Clinical Outcome in Renal Cell Carcinoma. Cancer Res 2017; 77: 1075-1082.
  12. Blanchet B, Carton E, Alyamani M, Golmard L, Huillard O, Thomas-Scheomann A, Vidal M, Goldwasser F, Sharifi N, Alexandre J. A PK/PD study of Delta-4 abiraterone metabolite in metastatic castration-resistant prostate cancer patients. Pharmacol Res. 2018;136:56-61.
  13. Motzer RJ, Rini BI, McDermott DF, Arén Frontera O, Hammers HJ, Carducci MA, Salman P, Escudier B, Beuselinck B, Amin A, Porta C, George S, Neiman V, Bracarda S, Tykodi SS, Barthélémy P, Leibowitz-Amit R, Plimack ER, Oosting SF, Redman B, Melichar B, Powles T, Nathan P, Oudard S, Pook D, Choueiri TK, Donskov F, Grimm MO, Gurney H, Heng DYC, Kollmannsberger CK, Harrison MR, Tomita Y, Duran I, Grünwald V, McHenry MB, Mekan S, Tannir NM; CheckMate 214 investigators. Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomized, controlled, phase 3 trial. Lancet Oncol.2019 Aug 16.

Annex 1:  Main indicators of clinical activities

 

2016

2017

2018

Number of new prostate cancer

342

374

349

Number of prostatectomy

137

152

129

Number of day-care treatments (chemotherapy) 

474

427

313

 

 

2016

2017

2018

Number of new kidneys cancers

278

259

243

Number of nephrectomies

229

243

205

Number of 1st line TKI or I-O in mKC

110

170

210

KC: Kidney cancer; TKi: Tyrosine kinase inhibitor

 

 

2016

2017

2018

Number of new bladders cancers

362

339

382

Number of cystectomy

180

190

182

Number of 1st line CT or I-O in mBC

180

220

270

 CT chemotherapy

 

 

2016

2017

2018

Number of new testicular cancer

19

24

24

Number of orchidectomy

16

24

22

Number of 1st line CT in mTC

10

15

16

 CT chemotherapy

Annex 2:  Ongoing Clinical Trials

 
Organ Sponsor Title Phase NCT number Coordinator / Investigator
Kidney PIVOTAL/ PT2977-202 An Open-Label Phase 2 Study to evaluate PT2977 for the Treatment of von Hippel-Lindau Disease-Associated Renal Cell Carcinoma II NCT03401788 Dr S. RICHARD / Pr S. OUDARD
Kidney Unicancer A phase II study assessing the safety of Nivolumab in patient with Metastatic Renal Carcinoma progressing during or after prior systemic anti-angiogenic therapy.( NIVOREN) II NCT03013335 Dr B.ESCUDIER / Pr S.OUDARD
Kidney ARTIC A Phase II BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR TKI in Na夫e Metastatic Kidney Cancer (BIONIKK) II NCT02960906 Dr Y. VANO / Pr S.OUDARD
Kidney Unicancer Secured access to nivolumab for adult patients with selected rare cancer types ( Cohort 1: Non clear cell RCC) (AcSE Nivolumab) II NCT03012581 Dr A.MARABELLE / Pr S. OUDARD
Kidney CHRU BESANCON Open Label, Randomized Multi-center Phase II Study to Assess the Efficacy and Tolerability of Sunitinib by Dose Administration Regimen (Dose Modification or Dose Interruptions) in Patients With Advanced or Metastatic Renal Cell Carcinoma (SURF) II NCT02689167 Dr A.THIERY-VUILLEMIN / Dr Y.VANO
Kidney BMS/ CA 209-214 A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy in Subjects with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma (CHECKMATE 214) III NCT02231749 Dr B.ESCUDIER / Pr S.OUDARD
Kidney BMS/ CA 209-025 A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy(CHECKMATE 025) III NCT01668784 Dr B.ESCUDIER / Pr S.OUDARD
Kidney EXELIXIS/ XL184-308 A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy (METEOR) III NCT01865747 Dr B.ESCUDIER / Pr S.OUDARD
Kidney MSD/ MK3475-564 A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564) III NCT03142334 Pr S.OUDARD / Pr S.OUDARD
Kidney MSD/ MK3475-426 A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in combination with Axitinib versus Sunitinib Monotherapy as a First-line Treatment for Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426) III NCT02853331 Pr C.LINASSIER / Pr S.OUDARD
Kidney EISAI A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects with Advanced Renal Cell Carcinoma (CLEAR). III NCT02811861 Pr S.OUDARD / Pr S.OUDARD
Prostate APHP A phase II study assessing intra-individual dose escalation of abiraterone acetate based on plasma concentration in patients with castration resistant metastatic prostate cancer and tumor progression (OPTIMABI) II NCT03458247 Pr J. ALEXANDRE / Pr S.OUDARD
Prostate MSD/MK 3475-365 Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration Resistant Prostate Cancer (mCRPC) (KEYNOTE-365) Ib/II NCT02861573 Dr G.GRAVIS / Pr S.OUDARD
Prostate ARTIC Randomized multicenter, phase III trial evaluating the safety of 2 schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (ウ 65years) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen (CABASTY) III NCT02961257 Pr S.OUDARD / Pr S.OUDARD
Prostate UNICANCER A phase 3 Randomized, placebo-controlled, Double blind Study of JNJ56021927 plus androgen Deprivation Therapy (ADT) versus ADT in subjects whit low volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC) III NCT02489318 Pr M.O.TIMSIT / Dr C.THIBAULT
Prostate JANSSEN/ 64091742PCR3001 A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer (MAGNITUDE) III NCT03748641 Dr A.THIERY-VUILLEMIN / Pr S.OUDARD
Prostate SOTIO/ SP005 Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (VIABLE) III NCT02111577 Dr N. BARRY DELONGCHAMPS / Pr S.OUDARD
Prostate PFIZER/ C3441021 A phase 3 randomized, double-blind, placebo-controlled study of talazoparib with enzalutamide in metastatic castration-resistant prostate cancer (TALAPRO-2) III NCT03395197 Pr K. FIZAZI /  Pr S.OUDARD
Prostate JANSSEN/ 56021927PCR3001: a phase III randomized, placebo controlled Double-blind Study of JNJ-56021927 in combination with Abiraterone Acetate and Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subject with Chemotherapy-na夫e Metastatic Castration-resistant Prostate Cancer(mCRPC) (ACIS) III NCT02257736 Pr S.OUDARD / Pr S.OUDARD
Prostate MEDIVATION/ MDV3100-14: A Multinational, Phase 3, randomized, double-blind, placebo-controlled, efficacy and safety study of Enzalutamide in patients with non metastatic castration-resistant prostate cancer (PROSPER)” III NCT02003924 Pr S.OUDARD / Pr S.OUDARD
Prostate ARAGON Pharmaceuticals A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN_509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer (SPARTAN) III NCT01946204 Pr S.OUDARD / Pr S.OUDARD
Prostate UNICANCER A randomized Phase III, factorial design, of cabazitaxel and pelvic radiotherapy in patients with localized prostate cancer and high-risk features of relapse (PEACE 2) III NCT01952223 Pr K. FIZAZI /  Pr S.OUDARD
Prostate SANOFI/ LPS14201 A randomized, open label, multicenter study of Cabazitaxel versus an Androgen Receptor (AR)-targeted agent (abiraterone or enzalutamide) in mCRPC patients previously treated with Docetaxel and who rapidly failed a prior AR-targeted agent (CARD) IV NCT02485691 Pr S.OUDARD / Pr S.OUDARD
Bladder ARTIC Neoadjuvant dose-dense MVAC In combination with durvalumab (MEDI4736) and tremelimumab in muscle-invasive urothelial carcinoma (NEMIO) I/II NCT03549715 Pr S.OUDARD / Dr C.THIBAULT
Bladder JANSSEN/ 427556493BLC2002    A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib plus JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Metastatic or Surgically Unresectable Urothelial Cancer with Selected FGFR Gene Alterations (NORSE) Ib/II NCT03473743 Dr Y.LORIOT /  Dr Y.VANO
Bladder IGR A Phase II Study Evaluating Neoadjuvant pembrolizumab monotherapy in Patients with Muscle-Invasive Bladder Cancer to Explore in vivo the Mechanisms of Action of pembrolizumab (PANDORE) II NCT03212651 Dr Y. LORIOT / Dr C. THIBAULT
Bladder NEKTAR Therapeutics/ NEKTAR 18-214-10 A Phase 2, randomized, non-comparative, open-label study of NKTR-214 in combination with nivolumab and of chemotherapy in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients with low PD-L1 expression (PIVOT-10) II NCT03785925 Dr Y. LORIOT / Dr C. THIBAULT
Bladder CHU Bordeaux Gemcitabine Cisplatin plus Avelumab or Gemcitabine Cisplatin as first-line treatment of patients with locally advanced or metastatic urothelial bladder carcinoma ( GSISAVE) II NCT03324282 Pr A. RAVAUD / Pr S.OUDARD
Bladder BOEHRINGER INGELHEIM /BI “Phase II open label single arm exploratory trial of oral Afatinib immunotherapy following platinum failure for patients with advanced/metastatic urothelial tract carcinoma with with genetic alterations in ERBB receptors.LUX-Bladder1″” 1200.261:” genetic alterations in ERBB receptors.LUX-Bladder1″” 1200.261:” II NCT02780687 Dr. A. Font / Pr S.OUDARD, Dr HUILLARD
Bladder IMMUNOMEDICS / TROPHY U-01 : A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy II NCT03547973 Dr HUILLARD
Bladder JANSSEN/ 42756493BLC3001 A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations (THOR) III NCT03390504 Dr Y. LORIOT /  Dr Y. VANO
Bladder BAYER / FORT-1: Phase 2/3 study of rogaratinib (BAY 1163877) vs chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma II/III NCT03410693 Dr HUILLARD
Bladder ASTELLAS/ 7465-CL-0301 An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects with Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) III NCT03474107 Dr M. GROS-GOUPIL / Dr Y.VANO
Bladder Unicancer An open label, randomized, phase III trial, evaluating efficacy of Atezolizumab in addition to one year BCG (Bacillus Calmette-Guerin) bladder instillation in BCG-naive patients with high-risk non-muscle invasive Bladder cancer (ALBAN) III NCT03799835 Pr M. ROUPRET / Dr C. THIBAULT- Dr HUILLARD
Bladder ROCHE/ WO29636 A phase III, open-label, multicenter randomized study of atezolizumab ( anti-PDL1 antibody) versus observation as adjuvant therapy in patients with high-risk muscle-invasive urothelial carcinoma after surgical resection (IMvigor010) III NCT02450331 Pr S. OUDARD / Dr HUILLARD
Bladder MSD/ MK 3475-905 Perioperative Pembrolizumab (MK-3475) Plus Cystectomy Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-905) III NCT03924895 Pr S. OUDARD / Dr HUILLARD
Bladder MSD /MK3475-361: Phase III study, randomized, controlled, evaluating pembrolizumab with or without a platinum-based CT versus CT alone in patient with advanced or metastatic urothelial carcinoma(KEYNOTE-361) III NCT02853305 Pr S. OUDARD / Dr HUILLARD
If you are interested by this program and want to candidate to a PhD, post doctoral position, contact the leader
Pr Stéphane Oudard

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Aurore Hattabi, PhD : Coordinatrice Scientifique du CARPEM
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