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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…

Risk factors for non-melanoma skin cancer (NMSC)
1. Skin carcinoma progression analyzed by genome-wide gene expression profiling and mimicked by validated organotypic in vitro human skin cancer models; towards an integrative system-biology approach and an in vitro screening method for targeted skin cancer therapies.
2. Genetic and environmental risk factors for the development of skin cancer in organ-transplant recipients.

Study 1:The ultimate goal is to abrogate or reduce the excessive burden of carcinomas in organ transplant patients. We aim to elucidate and establish consistent changes in genomic and expression (both mRNA and miRNA) profiles in the course of tumor…

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…

Treatment of anal intraepithelial neoplasia in HIV-positive patients, a triple-arm randomized clinical trial

To establish the preferred treatment of AIN to prevent the development of severe anal neoplasia (persistent AIN III or anal carcinoma) in HIV+ MSM and HIV+ woman.

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…

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…

In vivo reflectance confocal microscopy, a novel non-invasive tool for diagnosing skin cancer - a randomized controlled trial

RESEARCH QUESTION(S): Can in vivo reflectance confocal microscopy (RCM) correctly identify the subtype of basal cellcarcinoma (BCC)?Primary Objective: To study whether in vivo reflectance confocal microscopy (RCM) can correctly identify the subtype…

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.

DNA methylation profiling in blood of patients with cutaneous squamous cell carcinoma (cSCC) after organ transplantation

The main objective of this study is to identify changes in DNA methylation of CD3+ T cells associated with cSCC after organ transplantation.

SKINCATCH Trial: Skin cancer and tumor health care

The objective of this study is to improve skin cancer care in primary health care and provide a scientific basis for implementing guidelines regarding care of low risk skin cancers. In order to be able to shift curative oncological care from…

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-)…

A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma

PrimaryCompare the efficacy (measured by objective response rate [ORR] and overall survival [OS]) of intratumoral IMO-2125 in combination with ipilimumab versus ipilimumab alone.SecondaryAssess other measures of clinical benefit, safety,…

Phase 2 Study testing the COmbination of Vemurafenib With Cobimetinib in BRAF V600 mutated Melanoma Patients to Normalize LDH and Optimize immunotherapY with Nivolumab and Ipilimumab (COWBOY)

Primary objective:- To compare efficacy of induction vemurafenib + cobimetinib followed by ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B).Secondary Objectives- To describe duration of response and overall…

T-Cell Mediated Plaque Inflammation and Atherosclerosis in Stage III Melanoma Patients on (neo-)adjuvant Immune Checkpoint Inhibitors: a prospective matched cohort study

To investigate the effects of ICIs (anti-CTLA4, anti-PD1, combination anti-CTLA4/PD1) on vascular inflammation (PET-CT) in stage III melanoma patients. We hypothesize that the increase in vascular inflammation will be greater in the exposure group…

Role of host cell DNA methylation analysis in predicting non-regression or regression of high-grade anal intraepithelial neoplasia in HIV+ men trial (MARINE)

In this study we clinically validate if host cell DNA methylation markers can predict (non-)regression of HGAIN, thus determining the need of immediate treatment versus active surveillance and the safety of withholding treatment. This could prevent…

A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TREATMENT COMBINATIONS IN PATIENTS WITH MELANOMA (MORPHEUS-MELANOMA)

• To evaluate the efficacy of treatment• To evaluate the safety of treatment

Combination of targeted therapy (encorafenib and binimetinib) followed by combination of immunotherapy (ipilimumab and nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation : an EORTC randomized phase II study (EBIN)

This study has been transitioned to CTIS with ID 2023-505376-30-00 check the CTIS register for the current data. The primary objective is to prospectively assess whether a sequential approach with an induction period of 12 weeks with encorafenib +…

EMDR for Fear of Cancer Recurrence in Patients with Familial Melanoma. A waiting list control trial

Primary Objective: The aim of the proposed study is to investigate whether EMDR is effective in lowering fear of cancer recurrence in patients with familial Melanoma. Secondary Objective(s): effectiveness of EMDR and quality of life at 3 months…