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An open-label, Phase I study to assess safety, tolerability, radiation dosimetry, and imaging properties of 89Zr-labelled girentuximab (89Zr-girentuximab) for in vivo detection of clear cell renal carcinoma (CCRC) by positron emission tomography (PET) using different PET imaging methodologies.

The identification of RCC is crucial for planning possible surgery and treatment. The aim of this study is to investigate the safety, tolerability, radiation dosimetry, as well as the diagnostic performance of 89Zr-girentuximab PET/CT in patients…

A single-arm, open-label, multicenter study of enfortumab vedotin (ASG-22CE) for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor (CPI) therapy.

Primary:* * To determine the antitumor activity of single-agent enfortumab vedotin as measured by confirmed objective response rate (ORR) in patients with locally advanced or metastatic urothelial cancer who have previously received systemic therapy…

A phase III randomized, open-label, multi-centre, global study of Durvalumab and Bacillus Calmette-Guerin (BCG) administered as combination therapy versus BCG alone in high-risk, BCG-naive non-muscle-invasive bladder cancer patients

This study has been transitioned to CTIS with ID 2023-505341-23-00 check the CTIS register for the current data. To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance)…

Senescence and the early ageing phenotype after chemotherapy for testicular cancer: the SEA-CAT study

The aim of this study is to improve our understanding of the development of late effects after cancer treatment and reveal potential targets for intervention/prevention. Therefore we will investigate mechanisms behind the early ageing phenotype…

A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant
Chemotherapy plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post-
Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-
Invasive Bladder Cancer

This study has been transitioned to CTIS with ID 2024-512158-12-00 check the CTIS register for the current data. Primary Objectives: - To compare the pCR rate of neoadjuvant nivolumab/BMS-986205 + GC to neoadjuvant GC alone in all randomized…

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)

Study Objective(s):Primary-To compare the overall survival (OS) of subjects with locally advanced or metastatic urothelialcancer treated with enfortumab vedotin (EV) to the OS of subjects treated with chemotherapySecondary-To compare progression-…

Neoadjuvant AXITINIB plus AVELUMAB for patients with localized RCC and a moderate to high risk of recurrence

This study has been transitioned to CTIS with ID 2024-515825-27-00 check the CTIS register for the current data. To investigate efficacy of neoadjuvant axitinib and avelumab in patients with localized renal cell carcinoma with moderate to high risk…

ICRA (Improve Checkpoint-blockade Response in Advanced urothelial cancer), an adaptive clinical study to determine efficacy of combining weekly paclitaxel with tremelimumab +/- durvalumab (MEDI4736)

The standard first-line therapy for mUC patients is platinum-based chemotherapy, most commonly cisplatin. For patients that progress during or after platinum-based chemotherapy, anti-PD(L)1 therapy can be used, showing durable responses in a subset…

A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab (89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study)

Primary Objective:To evaluate sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth.Secondary…

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

This study has been transitioned to CTIS with ID 2023-510015-19-00 check the CTIS register for the current data. The treatment options currently available for MIBC- patients remain limited, current standard therapy is likely to result in modest…

Phase II study of oral metformin for intravesical treatment of non-muscle-invasive bladder cancer

The primary objective is to determine the complete response rate to administration of oral metformin Secondary objectives are: to determine the partial response rate, the overall safety of metformin, the quality of life during metformin treatment…

A Phase 2, Randomized, Open-Label Study of Nivolumab or Nivolumab/BMS-986205, Alone or Combined with Intravesical BCG in Participants with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer

Primary Objectives:- To estimate complete response rate, per pathology review committee (PRC), and its duration in CIS participantsSecondary Objectives:- To evaluate progression free survival, per pathologie review committee (PRC), for all…

A Phase 2/3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone with or without Abemaciclib in Patients with Metastatic Castration-Resistant Prostate Cancer

This study has been transitioned to CTIS with ID 2023-506777-36-00 check the CTIS register for the current data. Main objective:Part 1: To determine the RP2D of abemaciclib that may be safely administered to patients with mCRPC in combination with…

A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) that is Persistent or Recurrent Following BCG Induction (KEYNOTE-676)

This study has been transitioned to CTIS with ID 2022-501817-29-00 check the CTIS register for the current data. Cohort ATo compare the CRR for the combination of pembrolizumab + BCG versus BCG alone in participants with CIS.Cohort B- To compare the…

Feasibility study of high field 3.0T multiparametric magnetic resonance imaging for local staging of invasive urinary bladder tumours

-To demonstrate the value of MRI in the initial staging of bladder tumours-To evaluate the feasibility of the use of MRI to delineate bladder tumours for planning GTV for external beam radiotherapy

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)

This study has been transitioned to CTIS with ID 2022-501251-81-00 check the CTIS register for the current data. To compare disease free and overall survival of RCC patients, after adjuvant treatment with pembrolizumab after surgical renal resection…

Prevention of VEGF inhibitor-induced toxicity by salt restricton

To prospectively study the effect of salt restriction on the rise in blood pressure in response to anti-cancer treatment with the VEGF inhibitor sunitinib and regorafenib.

BioXmark liquid fiducial markers for image guided radiotherapy in bladder cancer, a safety and performance trial

This study will evaluate usability, safety and performance of a cystoscopic guided injection of a marker (BioXmark) at the tumor site in patients with bladder cancer on planning CT and CBCT during the irradiation period.

The impact of genetic predisposition in pediatric renal cancer: genotypic and phenotypic characterization

1. To determine the frequency of mutations in known and novel pediatric renal cancer predisposing genes.2. To structurally document phenotypic characteristics of children with renal cancer, to optimize genetic counseling and surveillance and…