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The ORANGE II PLUS - Trial: An international multicentre randomized controlled trial of open versus laparoscopic liver surgery (hemihepatectomy and postero-superior liver segment resection).

Hypotheses: - For patients undergoing a laparoscopic left or right hemihepatectomy (with or without the need for one additional hepatic wedge resection or metastasectomy), time to functional recovery is reduced by 2 days in comparison with patients…

A randomized, double-blind, placebo-controlled, multicenter Phase II trial investigating two doses of EMD 525797 in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

The main objective of this study is to investigate of the drug EMD 525797 is better then no treatment with subjects with metastasized asymptomatic or mild symptomatic mCRPC. The efficacy and safety of the drug EMD 525797 is evaluated.Primary…

A randomized, vehicle-controlled, double-blind, Phase I/IIa, multiple-dose, multiple-cohort, Proof of Concept study in Healthy Volunteers and Patients with Cutaneous T-cell Lymphoma to characterize the safety, efficacy, and pharmacodynamics of topical bimiralisib

HV cohort 1Primary Objectives* To characterize the local tolerability of topical bimiralisib after 21 days* To characterize the systemic PK of topical bimiralisib after 21 daysSecondary Objective* To characterize the safety of topical bimiralisib…

A RANDOMIZED, DOUBLE-BLINDED, DOUBLE-DUMMY, PLACEBO-CONTROLLED THOROUGH QTC STUDY WITH SINGLE ORAL DOSES OF CEDAZURIDINE IN HEALTHY SUBJECTS

The purpose of the study is to investigate the effect of cedazuridine on the values of specific electrocardiogram (ECG) parameters. One of these parameters is the QT -interval. The QT -interval indicates the recovery time of the heart muscle cells…

A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable, Stage IIIB to IVM1c Melanoma (MASTERKEY-265)

Primary Objectives:To evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression free survival (PFS) (response evaluation by blinded independent central review using modified…

A multicentre, double blind, randomised, placebo controlled, Phase II trial to evaluate Resminostat for maintenance treatment of patients with advanced stage (Stage IIB-IVB) mycosis fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy - the RESMAIN Study

Primary ObjectiveThe primary objective is to determine if maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB IVB) MF or SS that have achieved disease…

EPIK-P2: A Phase II double-blind study with an upfront, 16-week randomized, placebo-controlled period, to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)

This study has been transitioned to CTIS with ID 2023-508530-34-00 check the CTIS register for the current data. Primary objective:* To demonstrate the efficacy of alpelisib as measured by the proportion of participants randomized to alpelisib with…

A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

This study has been transitioned to CTIS with ID 2023-508606-26-00 check the CTIS register for the current data. Primary Objective:The primary objective is to compare the radiographic progression-free survival (rPFS) ofapalutamide in combination…

A Randomized, Active-Controlled, Blinded, Phase III Clinical Trial of BMS-986213 (Fixed Dose Combination of Relatlimab [anti-LAG-3] and Nivolumab) in Combination with Chemotherapy versus Placebo in Combination with Chemotherapy as First-Line Treatment in Participants with Unresectable, Locally Advanced or Metastatic LAG-3 Postive Gastric or Gastroesophageal Junction Adenocarcinoma

Primary ObjectivesThe main purpose of this study is to compare how long subjects with oesophageal cancer live overall (called overall survival, OS) or live without disease progression (called progression free survival, PFS) after receiving BMS-…