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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 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…

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.

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.

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, 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 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,…

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)…

Adjuvant peginterferon alfa-2b for 2 years vs Observation in patients with an ulcerated primary cutaneous melanoma with T(2-4)bN0M0: a randomized phase III trial of the EORTC Melanoma Group.

To prospectively assess the efficacy, toxicity, quality of life with peginterferon alfa-2b as compared to observation after adequate surgery for ulcerated primary cutaneous melanomas with T(2-4)bN0M0

Age-related changes of the immune system leading to hyporesponsiveness; a major player and predictor for biological behaviour of metastasized melanoma?

To study the frequencies and differentiation status of CD4 and CD8 T cell populations (Tnaive, TCM, TEM, TEMRA) in young (18-50) and old (>65) treatment naive metastasized melanoma patients at baseline and after treatment.

A Phase I, exploratory, intra-patient dose escalation study to investigate the preliminary safety, pharmacokinetics, and anti-tumor activity of pasireotide (SOM230) s.c. followed by pasireotide LAR in patients with metastatic melanoma or metastatic Merkel cell carcinoma

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)…

AN OPEN-LABEL, EXTENSION (ROLLOVER) STUDY OF VEMURAFENIB IN PATIENTS WITH BRAFV600 MUTATION*POSITIVE MALIGNANCIES PREVIOUSLY ENROLLED IN AN ANTECEDENT VEMURAFENIB PROTOCOL

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…

Topical sinecatechins ointment in treatment of primary superficial Basal Cell Carcinoma: a double blind, randomized, placebo-controlled trial.

Primary Objective: To determine whether topical sinecatechins 10% (Veregen®) ointment application can lead to a histological clearance (efficacy) of a superficial basal cell carcinoma. Secondary Objective(s): To assess compliance and adverse…

A single arm, open-label, phase II, multicentre study to assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma (BCC).

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.

An open-label, multicenter study to assess the safety of RO5185426
in patients with metastatic melanoma

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…

Metastases of cutaneous squamous cell carcinoma in organ transplant recipients - The *SCOPE-ITSCC metastases study*

The objective of this multicenter prospective observational study is to estimate in a follow-up period of 2 years the cumulative incidence of metastases in OTR with cutaneous invasive SCC. In addition we will estimate the contribution of risk…

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…

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…