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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

LITESPARK-033 (MK6482-033)

Phase 3, Randomized, Open-Label study of MK-6482 (Belzutifan)+Zanzalintinib vs. Cabozantinib for the Treatment of Participants with Locally advanced or Metastatic RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy

  • Principal investigator : Prof. Dr. Benoit Beuselinck
  • Sponsor :  Merck
  • More information : 
  • Indication : 
  • Internal reference number : s70902

STEAP1 (20230239)

A Phase3, Open-label, Multicenter, Randomized Study of Xaluritamig Monotherapy, Xaluritamig Plus Abiraterone versus Investigator's Choise in Participants with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

  • Principal investigator : Prof. Dr. H. Dumez
  • Sponsor : Amgen
  • More information : 
  • Indication : 
  • Internal reference number : s70847

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)

EFFORT 

Phase II prospective trial to evaluate the impact of 18F-FDG-PET-CT in stratifying patients with primary muscle invasive bladder cancer and tailoring the treatment accordingly (EFFORT)

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

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

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

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: 28 augustus 2025