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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 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03A

This study has been transitioned to CTIS with ID 2023-506838-68-00 check the CTIS register for the current data. Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment…

A phase III, multicenter, randomized, placebo-controlled, double-blind study of atezolizumab (anti-PD-L1 antibody) as adjuvant therapy in patients with renal cell carcinoma at high risk of developing metastasis following nephrectomy

Primary objective: To evaluate the efficacy of adjuvanttreatment with atezolizumabSee tabel 3 of the protocol.

A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Adult Subjects with Advanced, Relapsed or Refractory Renal Cell Carcinoma (RCC) with Clear Cell Differentiation

Primary Objective, Part A: To assess the safety of a single escalating dose and multiple dose regimen of CTX130 in subjects with unresectable or metastatic ccRCCPrimary Objective, Part B (Cohort Expansion): To assess the efficacy of CTX130 in…

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 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus bempegaldesleukin (NKTR-214), Versus Nivolumab Alone Versus Standard of Care in Participants with Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

Primary Objectives• To compare the pathologic complete response (pCR) rate of neoadjuvant nivolumab + NKTR-214 to Standard of Care (SOC, no neoadjuvant therapy) in all randomized participants• To compare the event-free survival (EFS) of neoadjuvant…

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B

This study has been transitioned to CTIS with ID 2023-506839-15-00 check the CTIS register for the current data. Primary objectives:# Safety Lead-in Phase: To assess the safety and tolerability, and to establish an RP2D if applicable, of treatment…

An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab, versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer

This study has been transitioned to CTIS with ID 2023-503421-19-00 check the CTIS register for the current data. This study will evaluate the efficacy, safety, and PK of enfortumab vedotin in combination with pembrolizumab, with or without platinum-…

A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus standard of care in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma

Primary Objectives• To compare the of OS rate at 12 months of Nivolumab combined with Ipilimumab to standard of care in patients with previously untreated and advanced non-clear cell RCC, Secondary Objectives• To compare the OS rate at 6 and 18…

Phase 1B Study to assess safety and efficacy of Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy (NABUCCO)

Primary objectives: 1. Establish whether a sequenced pre-operative schedule of ipilimumab and nivolumab is safe in urothelial cancer patients (cohort 1)2. Study objective for cohort 2: to evaluate which treatment regimen is most effective.…

Image-guided navigation during robot-assisted partial nephrectomy

The primary objective is to assess the ability to achieve preoperatively planned resection volumes by adding EM tracked navigation in RAPN, as minimizing the removal of healthy kidney tissue is challenging nowadays. A deviation within 35% between…

N15DOP: Phase I and pharmacological study of weekly ModraDoc006/r in combination with high-dose intensity-modulated radiation therapy in patients with high-risk early stage prostate cancer

To determine the maximum tolerated dose (MTD) of ModraDoc006/r (as ModraDoc006 10 mg tablets in combination with one tablet of 100 mg ritonavir) that can safely be administered in a bi-daily weekly schedule in combination with high-dose intensity…

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, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy in Subjects with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

This study has been transitioned to CTIS with ID 2023-504761-23-00 check the CTIS register for the current data. The co-primary endpoints of this study are PFS in intermediate and poor-risk subjects, as assessed by an Independent Radiology Review…

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…

A Phase 3, Multicenter, Multinational, Randomized, Open-Label, Parallel-Arm Study of Avelumab* (MSB0010718C) plus Best Supportive Care Versus Best Supportive Care Alone as a Maintenance Treatment in Patients with Locally Advanced or Metastatic Urothelial Cancer whose Disease did not Progress after Completion of First-Line Platinum-Containing Chemotherapy

To demonstrate the benefit of maintenance treatment with avelumab plus BSC vs. BSC alone in prolonging overall survival (OS) in patients with unresectable locally advanced or metastatic UC whose disease did not progress on or following completion of…

68Ga-PSMA-PET/CT and genomic alterations for future selection of patients with metastatic castration resistant prostate cancer (mCRPC) for Radium-223 treatment.

Primary Objective: • To determine the clinical Progression Free Survival (cPFS) in our study cohort of patients with mCRPC and 68Ga-PSMA-PET/CT selected bone-only disease (PET-bone only group). The cPFS will be compared to the cPFS of patients with…

A prospective study of primary metastatic renal cell carcinoma treated with immunecheckpoint inhibitors and cytoreductive nephrectomy vs primary tumour in place

The aim of this study is to investigate whether performing a cytoreductive nephrectomy has a beneficial effect on overall survival in patients with metastatic renal cancer receiving systemic therapy using immunocheckpoint inhibitors.

Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)

This study has been transitioned to CTIS with ID 2023-508926-91-00 check the CTIS register for the current data. To determine non-inferiority of preoperative 6 weeks of VCE to VAD in the overall metastatic rapid response rate (MetRR) in newly…

A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET-CT in Subjects with Selected Advanced or Metastatic Malignancies including Melanoma, Merkel Cell, Renal Cell and Non-Small Cell Lung Cancers, Scheduled to Receive Standard-of-Care Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy

Primary objective: evaluate the performance of zirconium Zr 89 crefmirlimab berdoxam PET-CT for predicting patient response to immunotherapy. Secondary objectives: - evaluate the performance of zirconium Zr 89 crefmirlimab berdoxam PET-CT for…