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The efficacy of an antigenic marker lesion for the therapeutic effect in patients with multiple, Ta/T1, G1/G2, non-muscle invasive bladder cancer (NMIBC) treated with TUR followed by IL-2 instillation

We like to demonstrate that treatment of non-muscle invasive bladder carcinoma with incomplete TUR and IL-2 is therapeutically more effective than treatment with complete TUR and IL-2.

A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel, Docetaxel or Vinflunine in Subjects with Recurrent or Progressive Metastatic Urothelial Cancer

Primary Objectives(1) To evaluate the overall survival (OS) of subjects with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy (recurrent/progressive metastatic…

Phase III randomized sequential open-label study to evaluate the efficacy and safety of sorafenib followed by pazopanib versus pazopanib followed by sorafenib in the treatment of advanced / metastatic renal cell carcinoma

Primary:To evaluate if progression-free survival from randomization to progression or death during second-line therapy (total PFS) of sorafenib followed by pazopanib is non-inferior compared to pazopanib followed by sorafenib.Secondary:1. Time from…

Phase 3 Randomized, Double-Blind Clinical Study of Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo as a Treatment for Recurrent or Progressive Metastatic Urothelial Carcinoma in Patients who have Failed a First-Line Platinum-containing Chemotherapy Regimen for Advanced/Metastatic Disease (KEYNOTE-698/ECHO-303)

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with advanced/…

A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination with Epacadostat (INCB024360) or Placebo in Participants with Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

The objective of this study is to test the safety, tolerability and anti-tumor activity of the combination of the investigational products epacadostat and pembrolizumab, compared to pembrolizumab as mono therapy, in patients with cisplatin-…

a phase III randomised trial of intravesical chemotherapy vs thermo-chemotherapy in intermediate risk non-muscle invasive bladder cancer

To compare standard treatment with intravesical chemotherapy with loco-regional thermo-chemotherapy in patients with an intermediate risk non-muscle invasive urothelial carcinoma of the bladder after complete transurethral resection of the tumour(s…

A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy

The objective of this study is to evaluate the effect of cabozantinib compared with everolimus on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine…

A randomized, controlled Phase III study investigating IMA901 multipeptide cancer vaccine in patients receiving sunitinib as first-line therapy for advanced/metastatic renal cell-carcinoma.

The primary objective of the present phase III study is to investigate whether IMA901 can prolong overall survival in patients with metastatic and/or locally advanced renal cell carcinoma (RCC) when added to standard first-line therapy with…

An open-label, randomized, multi-center, Phase III study to compare the safety and efficacy of TKI258 versus sorafenib in patients with metastatic renal cell carcinoma after failure of anti-angiogenic (VEGF-targeted and mTOR inhibitor) therapies

* To compare TKI258 vs. sorafenib with respect to progression-free survival (PFS) determined by central radiology assessment in patients with metastatic renal cell cancer (mRCC) after failure of anti-angiogenic (VEGF-targeted and mTOR inhibitor)…

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients with Locally Advanced or Metastatic Adrenocortical Carcinoma

The primary objective of this study is to determine the overall survival (OS) of single agent OSI-906 (Arm A) versus placebo (Arm B) in patients with adrenocortical carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens.

Randomized Phase III trial comparing immediate versus deferred nephrectomy in
patients with synchronous metastatic renal cell carcinoma.
EORTC 30073 SURTIME

The principal objective of the trial is to investigate whether the sequence of the nephrectomy in patients who receive sunitinib has an effect on patient outcome.

A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared with Mitomycin C in the Intravesical Treatment of Subjects with BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer

The primary objective of this study is to evaluate the efficacy of EN3348 as compared with mitomycin C in the treatment of subjects with BCG recurrent or refractory NMIBC.The secondary objective is to evaluate the safety of EN3348 as compared with…

A randomized, double-blind, placebo-controlled, multicenter phase III study to compare the safety and efficacy of RAD001 plus Best Supportive Care (BSC) versus BSC plus Placebo in patients with metastatic carcinoma of the kidney which has progressed on VEGF receptor tyrosine kinase inhibitor therapy.

To compare progression-free survival (PFS) in patients who receive RAD0901 plus Best Supportive Care (BSC) versus patients who receive Matching Placebo plus BSC.

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)…

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-…

A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM
STUDY OF AVELUMAb (MSB0010718C) IN COMBINATION WITH AXITINIB
(INLYTA®) VERSUS SUNITINIB (SUTENT®) ) MONOTHERAPY IN THE
FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL
CARCINOMA

Primary ObjectiveTo demonstrate that avelumab in combination with axitinib is superior to sunitinib monotherapy in prolonging PFS or OS in the first-line treatment of PD-L1 positive patients with aRCC.Secondary Objectives* To demonstrate that…

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…

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 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…

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-…