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A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the
Safety and Efficacy of Two Dosing Schedules of Pembrolizumab (MK-3475) Compared to Ipilimumab in Patients with Advanced Melanoma

1. To evaluate progression-free-survival (PFS) in patients with advanced MEL receiving either Pembrolizumab or IPI.2. To evaluate overall survival (OS) in patients with advanced MEL receiving either Pembrolizumab or IPI.

Surgical excision versus combined therapy with Curettage and Imiquimod for Nodular Basal Cell Carcinoma: an open, non-inferiority, randomized controlled trial

Primary objective: To compare long-term efficacy of curettage prior to IMQ 5% cream (Aldara®) therapy versus standard surgical excision in primary nBCC.Secondary objective: To assess compliance, pain, cosmetic outcomes, patient satisfaction, patient…

Minitub: Prospective registry of Sentinel Node (SN) positive melanoma patients with minimal SN tumor burden who undergo Completion Lymph Node Dissection (CLND) or Nodal Observation

With this prospective registry we aim to evaluate the outcome of patients with a T2-T3 primary melanoma and minimal SN tumor burden, treated by CLND or nodal observation:* The main objective is to determine if T2-T3 melanoma patients with minimal SN…

A Phase III randomized, open-label study comparing GSK2118436 to DTIC in previously untreated subjects with BRAF mutation positive advanced (Stage III) or metastatic (Stage IV) melanoma (BRF113683)

Primary: superiority of GSK2118436 over DTIC with respect to progression-free survival for subjects with BRAF mutation positive metastatic melanoma.Secondary: overall survival, best overall response, duration of response, non-melanoma skin lesions,…

An exploratory study of the biologic effects of nivolumab and nivolumab in combination with ipilimumab treatment in subjects with advanced melanoma (unresectable or metastatic).

Primary Objective:To investigate the pharmacodynamic activity of nivolumab, and nivolumab in combination with ipilimumab in the tumor environment and the periphery on biomarker measures such as circulating T cell subsets (activated and memory T…

Randomized controlled trial for the cosmetic result of intracutaneous versus transcutaneous sutures after dermatologic surgery in the face

Evaluation of the cosmetic result after 12 months of transcutaneous sutures versus intracutaneous sutures in the craniofacial area.

Immunochemotherapy: Do platin-based chemotherapeutics enhance dendritic cell vaccine efficay in melanoma patients?

This is an exploratory study and the primary objective is the immunogenicity and feasibility of combined chemotherapy-DC vaccination. The secondary objectives are the toxicity and clinical efficacy. This study will provide important data on the…

A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma

The primary objective of this study is to compare the overall survival (OS) of patients whohave received one prior regimen of dacarbazine or temozolomide-based chemotherapy for metastaticmelanoma when treated with either tasisulam or paclitaxel.The…

A Randomized, Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy.

Primary Objective* To compare the objective response rate and overall survival of BMS-936558 to investigator*s choice in subjects with advanced melanoma.Secondary Objectives* To compare the progression-free survival (PFS) of BMS-936558 to…

BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine.

Primary objective:To evaluate efficacy of RO5185426 as a monotherapy compared to dacarbazine in terms of progression-free survival (PFS) and overall survival (OS) in previously untreated patients with advanced melanoma harbouring the BRAF V600E…

A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg vs
at 10 mg/kg in Subjects with Previously Treated or Untreated Unresectable or Metastatic
Melanoma

To compare the overall survival of ipilimumab monotherapy at doses of 3 mg/kg versus 10 mg/kg in subjects with previously treated or untreated unresectable Stage III or Stage IV melanoma

TLR ligand matured dendritic cell vaccination in melanoma patients: the key towards a more potent immune induction?

This is an exploratory study, consisting of two parts. In part I a dose escalation is performed and the primary objective is the safety of different doses of TLR-DC. In part II TLR-DC vaccination will be compared with cytokine-matured DC vaccination…

A Multi-Center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients with Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg of Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

To compare OS in patients with previously untreated Stage IIIc, N3 (unresectable) or Stage IV melanoma receiving dacarbazine plus 10mg/kg ipilimumab (MDX-010) vs. dacarbazine with placebo.

A Phase 3 Clinical Trial to evaluate the safety and efficacy of treatment with 2 mg intralesional Allovectin-7® compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in subjects with recurrent metastatic melanoma

The objective of the trial is to compare the efficacy and safety of treatment with Allovectin 7® versus treatment with DTIC or TMZ in subjects with recurrent metastatic melanoma. The results of the trial will be used to support registration of…

The TEAM trial (Tasigna efficacy in advanced melanoma): A randomized, phase III, open label, multi-center, two-arm study to compare the efficacy of Tasigna® versus dacarbazine (DTIC) in the treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation

Primary objective:* To compare the clinical efficacy of nilotinib to DTIC, based on progression free survival (PFS), in the treatment of c-Kit mutated melanoma in patients who have not received prior therapy with TKIs.Key secondary objectives:* To…

Prospective randomised controlled study on tumescent local anesthesia for Mohs Micrographic Surgery ( MMS) compared to conventional anesteshia with lidocaine/ epinephrine 1 %

1. Less experience of pain by using TLA unlike lidocaine/epinephrine 1 %.2. Little intraoperative bleeding because of the vasoconstrictive effect of TLA.3. Long lasting analgesia, also postoperative.

Single-step antigen loading and TLR activation of dendritic cells by mRNA electroporation for vaccination in stage III and IV melanoma patients

This is an exploratory study, consisting of two parts. In part I dose escalation is performed and the primary objective is the safety of different doses of TLR-DC and Trimix DC. In part II Trimix DC vaccination will be compared with TLR-DC…

Prospective randomised controlled study on imiquimod 5% cream as pre-treatment of Mohs micrographic surgery for primary large nodular basal cell carcinoma in the face.

Objectives1. Reduction of defect size after MMS with a pre-treatment with imiquimod 5% cream2. Reduction of tumour size of large nodular facial BCC, after pre-treatment with imiquimod 5% cream.3. Improvement of cosmetic results.4. Histological…

Myeloid and plasmacytoid blood dendritic cells for immunotherapy of stage III melanoma patients

This is an interventional study and the primary objective is the immunogenicity of combined pDC and myDC vaccination. The secondary objectives are the biodistribution, the safety, quality of life and overall survival.

Longterm carcinogenic effects of daily low emission phototherapy in psoriasis

To ascertain the amount of UV-damage (p53 activation, apoptosis, thymidine dimers and γH2AX) is caused by the Dermasun treatment in psoriasis patients.Total skin check in patients using Dermasun for a prolonged period of time to screen for (pre-)…