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An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor Vemurafenib in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine.

Primary Objective• To evaluate best overall response rate (BORR; CR + PR) in Cohort 1 (TKI-naïve patients).* BORR will be based on investigator assessment, based on the findings on computed tomography (CT) or magnetic resonance imaging, using RECIST…

A phase 1, open-label multicenter, 3-period, fixed-sequence study to investigate the effect of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in patients with BRAFV600 mutation positive metastatic malignancy

The primary objective of this study is to evaluate the effect of multiple oral doses of vemurafenib (960 mg BID) on the PK of a single oral dose of acenocoumarol (4 mg).The secondary objective of this study is to assess the safety and tolerability…

Within-patient comparison of Senti-Scint and ICG-99mTc-nanocolloid for sentinel node biopsy of melanoma of the head and neck, of the trunk or of an extremity

To compare ICG-99Tc-nanocolloid to 99mTc-Senti-Scint for sentinel node mapping in patients with malignant melanoma of the trunk, an extremity or in the head and neck area.

A randomized, double-blinded, regimen controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas (BCCs).

The primairy objective of this fase II study, is to compare two treatment regimens of vismodegib in two populations of patients with multiple BCC's (patients with Gorlin syndrome and patients who do not have Gorlin syndrome). Primary to assess…

A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec

In this study, we explore the correlation between baseline intratumoral CD8+ cell density and objective response rate (ORR) as well as other biomarker parameters in subjects with unresected stage IIIB to IVM1c melanoma treated with talimogene…

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…

MAL-PDT of superficial basal cell carcinoma using two light fractions with one or two hours interval: comparison of illumination at 3 and 4 hours with illumination at 3 and 5 hours after application of MAL

The aim of the present study is to study Metvix® photodynamic therapy (MAL-PDT) of superficial basal cell carcinoma (sBCC) using two light fractions with one or two hours interval: comparison of illumination at 3 (20 J/cm2) and 4 hours (55 J/cm2)…

A phase Ib/II, multicenter, open label, study of LEE011 in combination with MEK162 in adult patients with NRAS mutant melanoma

Primary objective: Phase Ib (see study design): Maximum Tolerated Dose(s) and/or Recommended Phase II Dose (RP2D) of LEE011 and MEK162 in combination. Phase II (see study design): Assess the anti-tumor activity of the LEE011 and MEK162 combination…

Randomized, Phase II Study of Pembrolizumab (MK-3475) versus Chemotherapy in Patients with Advanced Melanoma (KEYNOTE 002).

1. To evaluate the progression-free-survival (PFS) in patients with ipilimumab refractory advanced MEL receiving either MK-3475 or chemotherapy.2. To evaluate the overall survival (OS) in patients with ipilimumab refractory advanced MEL receiving…

A phase II, multi-center, open-label study of sequential LGX818/MEK162 combination followed by a rational combination with targeted agents after progression, to overcome resistance in adult patients with locally advanced or metastatic BRAF V600 melanoma

To assess the anti-tumor activity of LGX818/MEK162 in combination with third targeted agents after progression on LGX818/MEK162 combination therapy.

In vivo assessment of pigmented skin lesions by Raman spectroscopy

Primary Objective: to explore the feasibility and to identify potential hurdles of in vivo assessment of pigmented skin lesions by Raman spectroscopy.Secondary Objective(s): - to compare in vivo measurements with the results obtained by ex vivo…

A Phase II, Open-Label, Multicenter Study of Vemurafenib plus Cobimetinib (GDC-0973) in Unresectable Stage IIIc or Stage IV Melanoma; Response Monitoring and Resistance Prediction with Positron Emission Tomography and Tumor Characteristics.

To study whether either early 18F-FDG or 18F-FLT PET is superior in detecting response to treatment with the combination of vemurafenib plus cobimetinib (GDC-0973) compared to standard response assessment with CT and to evaluate whether, and which,…

Clinical diagnosis versus histological diagnosis by punch biopsy to determine the subtype of basal cell carcinoma

To establish the diagnostic value of clinical diagnosis to predict the histological BCC subtype and compare this by the diagnostic accuracy of PB to determine the subtype of BCC in the subsequent SE/MMS specimen.

A multicentre, open label, Phase I trial of the MEK inhibitor MSC1936369B given orally to Subjects with Solid Tumours

The purpose of this trial is to determine the maximum tolerated dose (MTD) and the doselimiting toxicity (DLT) in a population of subjects with malignant solid tumours, and to generate safety, PK and Pd marker information. Anti-tumour effects over…

Longitudinal analysis of tumor-specific T-cel immunity in irresectable stage IIIc and stage IV melanoma patients

• To study the effect of treatment (e.g. anti-CTLA4, BRAF inhibition, TIL therapy) on the size and diversity of melanoma-specific T cell populations as measured by MHC tetramer technology and antigen-specific cytokine production. • To examine…

Enhancing anti-melanoma activity of T-cells

To test in vitro and in vivo therapeutic effects of new immunotherapeutic strategies in preclinical in vitro models and in mouse models on melanoma patient derived malignant cells.

An open Phase I Study of immunization with the recNY-ESO-1 + AS15 Antigen-Specific Cancer Immunotherapeutic in patients with NY-ESO-1-positive unresectable and progressive metastatic cutaneous melanoma.

Primary: Document and characterize the severe toxicity and clinical activity of the recNY-ESO-1 + AS15 ASCI in patients with NY-ESO-1-positive metastatic cutaneous melanoma.Secondary: Document and characterize additional clinical indicators of…

Melanoma, artificial reproductive therapy and pregnancy; is there an increased risk of recurrence?

The aim of this study is to evaluate if a recurrent melanoma is more common after ART or pregnancy after a previous history of stage I or II melanoma. Other forms of hormonal therapy will be examined. Also, anxiety about pregnancy or hormonal…

Gamma Probe and Ultrasound Guided Fine Needle Aspiration Cytology of the Sentinel Node Trial

To study the sensitivity of the combined gamma probe and US guided FNA compared to the gold standard histology of the surgically removed SNB. Secondary aims 1) to study the identification rate of this technique 2) to study possible differences in…

Identification of predictive parameters for colitis in melanoma patients treated with immunotherapy.

To identify predictive parameters for colitis in melanoma patients treated with immunotherapy