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Algemene medische oncologie

Klinische studies Genito-urinaire tumoren (nier, blaas, urinewegen, prostaat, penis en testis)

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Planned

BET-PSMA-121

An open-label, multicentre, integrated Phase 1 & 2 study to evaluate the safety, tolerability, radiation dosimetry and anti-tumour activity of Lutetium (177Lu) rhPSMA-10.1 injection in men with metastatic castrate-resistant prostate cancer

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Blue Earth Therapeutics Ltd
  • More information : NCT05413850
  • Indication : 
  • Internal reference number : s67317

M25-204

A Phase 2, Open-Label, Randomized Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC) 

PRIAM - N22APC

A Phase 2 clinical study to assess efficacy of induction carboplatin/paclitaxel + pembrolizumab for locoregionally advanced penile cancer: PRIAM

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Nederlands Kanker Instituut AVL
  • More information : NCT06353906
  • Indication : 
  • Internal reference number : s69611

XmAb819-01 (2281/0141)

Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®30819 in Subjects with Relapsed or Refractory Clear Cell Renal Cell Carcinoma (ccRCC)

Ongoing

BicycleTx  Duravelo-2 - BT8009-230

A Phase 2 Single-Arm Study of BT8009 in Combination with Pembrolizumab in Participants with Previously Untreated Locally Advanced or Metastatic Urothelial Cancer Ineligible for Cisplatin-Based Chemotherapy (Duravelo-2)

IMCODE004 - BO45230

A Randomized Phase II Double-Blind Multicenter Study of Autogene Cevumeran Plus Nivolumab Versus Placebo Plus Nivolumab as Adjuvant Therapy in Patients with High-risk Muscle-invasive Urothelial Carcinoma. 

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Hoffmann-La Roche
  • More information : NCT06534983
  • Indication : 
  • Internal reference number : s68970

Closed

AARDVARC - D8731C00002

A Phase 2, open-label, study to assess the efficacy, safety and tolerability of AZD4635 in combination with durvalumab and the combination of AZD4635 with cabazitaxel and durvalumab in patients who have progressive metastatic castrate­ resistant prostate cancer

CARD 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

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Sanofi-Aventis
  • More information : NCT02485691
  • Indication : 
  • Internal reference number : s58070

DANUBE D419BC00001

A phase III, randomized, open-label, controlled, multi-center, global study of first-line MEDI4736 monotherapy and MEDI4736 in combination with tremelimumab versus standard of care chemotherapy in patients with unresectable stage IV urothelial bladder cancer

EV-301 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

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Astellas Pharma Global Development, Inc.
  • More information : NCT03474107
  • Indication : 
  • Internal reference number : s61328

EV-302 SGN22E-003

An open-label, randomized, controlled phase 3 study of enfortumab vedotin administered in combination with pembrolizumab, with or without platinum chemotherapy, versus platinum-containing chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer  

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Seattle Genetics
  • More information : NCT04223856
  • Indication : 
  • Internal reference number : s64269

FIGHT 205 - INCB 54828-205

A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Incyte Corporation
  • More information : NCT04003610
  • Indication : 
  • Internal reference number : s63296

FORT-1 - BAY 1163877 (17403)

A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy

IMVIGOR010 WO29636

A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Urothelial Carcinoma After Surgical Resection

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Hoffmann-La-Roche
  • More information : NCT02450331
  • Indication : 
  • Internal reference number : s58126

IMVIGOR130 WO30070

A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti−PD-L1 Antibody) as Monotherapy and in Combination With Platinum-Based Chemotherapy in Patients With Untreated Locally Advanced or Metastatic Urothelial Carcinoma

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Hoffmann-La-Roche 
  • More information : NCT02807636
  • Indication : 
  • Internal reference number : s60154

KEYNOTE-905 MK3475-905

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Cisplatin-ineligible Participants With Muscle-invasive Bladder Cancer

MEDIVATION MDV3800-06

A Phase 2, Open-label, 2-arm, Response Rate Study Of Talazoparib In Men With Dna Repair Defects And Metastatic Castration-resistant Prostate Cancer Who Previously Received Taxane-based Chemotherapy And Progressed On At Least 1 Novel Hormonal Agent (Enzalutamide And/or Abiraterone Acetate/Prednisone)

NIAGARA D933RC00001

A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer

PROOF 302 QBGJ398-302

Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : QED Therapeutics, Inc.
  • More information : NCT04197986
  • Indication : 
  • Internal reference number : s64201

SAUL MO29983

An open-label, single-arm, multicenter, safety study of atezolizumab in locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Hoffmann-La-Roche
  • More information : NCT02928406
  • Indication : 
  • Internal reference number : s59972

TROPiCS-04 - IMMU-132-13

A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Immunomedics
  • More information : NCT04527991
  • Indication : 
  • Internal reference number : s64896

VISION PSMA617-01

An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Laatste aanpassing: 23 oktober 2024