61 results
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…
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…
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…
To assess the anti-tumor activity of LGX818/MEK162 in combination with third targeted agents after progression on LGX818/MEK162 combination therapy.
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)…
PrimaryAssess the safety profile of pasireotide s.c. during the first 8 weeks of treatment with pasireotide s.c.SecondaryAssess the safety profile of pasireotide s.c.at study completionAssess tumor response as measured by disease control rate (DCR)…
The primary objective of this study is to provide continued access to vemurafenib for eligible patients with BRAFV600 mutation-positive malignancy who were previously treated in an antecedent vemurafenib protocol and did not meet the protocol*s…
The primary objective of this phase II study is to assess the safety of vismodegib in patients with (inoperable) locally advanced BCC or metastatic BCC.
Primary: To evaluate the safety and tolerability of RO5185426 inpatients with metastatic melanoma (Stage IV; AJCC) harboringthe BRAF V600 mutationSecondary: To evaluate the efficacy of RO5185426 as objectiveresponse rates (ORRs) determined by the…
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…
The primary purpose of the phase Ib part of this study is to determine the maximum tolerated dose(s) (MTD(s)) and/or recommended phase II dose (RP2D) in patients with BRAF mutant melanoma, and to delineate a clinical dose to be used in future…
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…
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…
1. The primary objectives of this phase I/II clinical trial is to demonstrate feasibility and evaluate the safety and toxicity of ACT plus vaccination according to CTCAE 4.0 criteria.2. Secondary objectives include the evaluation of the clinical…
The purpose of this phase II study is to assess the efficacy and safety of oral treatment with two dose levels of LDE225, as measured by objective response rate (ORR), in patients with locally advanced or metastatic BCC. Additional assessments…
Primary objectives: To assess the ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0-resection. Secondary objectives: Recurrence free survival; time-to-next treatment, overall survival.
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.
Therapeutic Drug Monitoring of BRAF- and MEK-inhibitors in a *Real Life* Cohort of Melanoma Patients
To describe the PK variability in exposure to vemurafenib, dabrafenib and trametinib and relationship with treatment outcome (Radiological tumor assessments as per RECIST Version 1.1) and toxicity (graded on basis of the National Cancer Institute…
Primary objective:* To assess the clinical efficacy of nilotinib, based on overall response rate (ORR), in thetreatment of c-Kit mutated melanoma in patients who have not received prior therapy withTKIs.Key secondary objectives:To assess the durable…
1) To determine clinical safety and tolerability of local i.d. administration of a single dose of tremelimumab in clinical stage II melanoma patients scheduled to undergo a SLN procedure. 2) To ascertain the immunological effects of local i.d.…