118 results
To assess the efficacy of MEDI4736 + tremelimumab combination therapy versus SoC in terms of OS in patients with UC.
The revised aims of the SORCE trial are:1. Does up to three years of treatment with sorafenib increase DFS compared with placebo: a comparison of Arm C vs Arm A2. If the answer to question (i) is yes, does one year of sorafenib (Arm B) increase DFS…
1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatmentwith Enzalutamide in patients with metastatic prostate cancer.2. To evaluate how these 2 imaging modalities perform…
Main objective:- Evaluate the anti-tumor activity per RECIST 1.1 in participants with metastatic or locally advanced/unresectable urothelial cancer treated with bintrafusp alfa. Secondary objectives: - Evaluate other measures of antitumor activity…
This study has been transitioned to CTIS with ID 2023-503500-87-00 check the CTIS register for the current data. This study is designed to assess the antitumor efficacy and safety of pembrolizumab + CRT following maximal TURBT compared with placebo…
- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 7 days per dosing cycle - Evaluate the pharmacokinetics of gemcitabine and 2',2'-difluorodeoxyuridine (dFdU, a gemcitabine-related metabolite) exposure in…
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 aim of this phase IVI, randomized, open-label study is to compare the efficacy of cabazitaxel versus an AR targeted agent, in patients previously treated with docetaxel and likely to have primary resistance to AR targeted agents.
Part APrimary objective:To determine the equivalent dose of pazopanib when taken with a continental breakfast compared to 800 mg in fasted state.Secondary objective:To monitor the occurrence of adverse events of pazopanib with and without food…
The aim of this study is to evaluate the dosimetry and toxicity of Lutetium-177-PSMA-617, in patients with low volume, hormone sensitive metastatic prostate cancer.
Based on the above, we propose to perform a prospective pharmacokinetic cross-over trial to test the hypothesis that splitting pazopanib intake moment will increase Cmin and AUC0-24h. In addition, we will show that this is a feasible, safe and cost-…
Objectives: To compare PFS using RECIST 1.1 as assessed by BICR and OS in PD-L1 positive subjects and all subjects between the following treatment comparisons:(a) Pembrolizumab + chemotherapy versus chemotherapy(b) Pembrolizumab versus…
The objectives of this study are to:- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 21 days per dosing cycle.- Evaluate the pharmacokinetics of gemcitabine and 2', 2'-difluorodeoxyuridine (dFdU, a…
- To study the success rate of organoid culture from lymph node, visceral and bone metastases in metastasized urogenital cancer and examine which parameters influence the success rate (culture media, biopsy site, cell counts). - To study the…
The primary objective of this study is to establish the success rate of culturing organoids from CTCs obtained by LA. Secondary objectives include to assess the fraction of metastatic PCa patients who have * 300 viable CTCs obtained by LA, the…
This study has been transitioned to CTIS with ID 2022-502526-41-00 check the CTIS register for the current data. Objective- To evaluate anti-tumor activity of pembrolizumab (MK-3475) by evaluating the absence of high risk NMIBC or progressive…
Primary Objective:To evaluate the anti-tumor activity of pembrolizumab (MK-3475) (200 mg Q3W) as 1L therapy in subjects with advanced/unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. Objective…
This combined phase I and II study is proposed to find the appropriate save dose level of one-fraction HDR-BT as monotherapy for low-risk PCa (phase I) and to evaluate the toxicity and clinical outcome of this dose level (phase II). In phase I,…