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A phase III prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as therapy in patients with operable Her2-positive early breast cancer.

The main purpose of this study is to determine the side effects of trastuzumab when it is given by each of these subcutaneous injection methods. The study will also gather information about whether and when the cancer comes back after taking…

A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…

Treatment of Targeted Therapy-Related Fatigue in Patients with CML or GIST: A Single-Case Experimental Design

To investigate the efficacy of cognitive behaviour therapy (CBT) on reducing TTF in patients receiving TKIs for CML or GIST.

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…

Advance Care Planning; an Innovative Palliative Care Intervention to Improve Quality of Life in Cancer Patients *a Multi-Centre Cluster Randomized Clinical Trial

We will investigate whether the Respecting Choices program will improve communication between patients and healthcare professionals, will improve the QOL and wellbeing of patients and their relatives, will reduce futile treatments and unnecessary…

A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB VERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATED BRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

Efficacy ObjectivesThe primary efficacy objective of study GO28141 is as follows:* To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive…

A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

Primary: To compare the proportion of patients demonstrating Major Molecular Response (MMR) at 12 months (48 weeks) in the bosutinib arm with that of the imatinib arm in newly diagnosed Philadelphia chromosome positive (Ph+) chronic phase (CP)…

STATEC: A randomised trial of non-selective versus selective adjuvant therapy in high risk
endometrial cancer

To determine the clinical effectiveness of adjuvant therapy given to all unstaged (no lymph node dissection) high risk stage 1 endometrial cancer, compared with only node positive (staged) cases as judged by full lymph node dissection.

Topical Vitamin D3, Diclofenac or a combination of both to treat Basal Cell Carcinoma

Primary Objective: To determine whether topical application of Calcitriol (Silkis) 3 µg/g, Diclofenac 10% or a combination of both can lead to a 40% histological reduction (*)/increase (*) of expression of the following antibodies: Ki67 (*), BCL2…

Multi-centre, randomized, investigator-blind, intra-individual active and vehicle-controlled study, comparing Metvix® Natural Daylight Photodynamic Therapy versus Metvix® conventional Photodynamic Therapy in subjects with actinic keratosis

Primary efficacy objective:To show the non-inferior efficacy of Metvix® Natural Day Light Photo Dynamic Therapy (NDL-PDT) versus Metvix® conventional Photo Dynamic Therapy (c-PDT) in Subjects with mild and moderate AKs at Week 12 in terms of percent…

An Open-Label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy

To compare prostate-specific antigen (PSA) progression-free survival (PFS) failure rates during long-term treatment with 3-monthly subcutaneous (s.c.) injections of degarelix or goserelin in prostate cancer patients (PSA PFS failure is defined as…

Xerostomia after submandibular gland sparing radiotherapy

The objective of this study is to determine the prevalence of xerostomia after radiotherapy of oropharyngeal tumors when sparing the parotid glands and one submandibular gland.

Ultraviolet related DNA-damage in skin of patients with atopic dermatitis and atopic status in relation to the use of Myfortic®

The primary aim is to study the effect of treatment of severe AD patients with Myfortic on DNA-repair after irradiation with UVB.A secondary aim is to study the effect of treatment of severe AD patients on atopic status, measured as total IgE and…

A phase III, multicenter, randomized, open-label study of oral LDK378 versus standard chemotherapy in adult patients with ALK-rearranged (ALK-positive) advanced non-small cell lung cancer who have been treated previously with chemotherapy (platinum doublet) and crizotinib

The primary objective is to compare the antitumor activity of LDK378 versus reference chemotherapy.The key secondary objective is to compare Overall Survival (OS) in patients treated with LDK378 versus reference chemotherapy (pemetrexed or docetaxel…

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…

Sentix: A prospective observational trial on sentinel lymph node biopsy in patients
with early stage cervical cancer

To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy.The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the…

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 Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma;

Primary objectives:(1) Evaluate Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded central radiologists' review in subjects with PD-L1 Combined Positive Score (CPS) *1. (2) Evaluate overall survival (OS).Secondary Objectives(…

A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK-positive), stage IIIB or IV, non-squamous non-small cell lung cancer

The primary objective is to compare the antitumor activity of LDK378 versus reference chemotherapy

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of
Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma

Primary: To determine the efficacy and safety of bel-sar compared to sham control for thetreatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).Secondary: To assess the systemic pharmacokinetics (PK) and immunogenicity of…