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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…

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 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.

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 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…

Adoptive T cell therapy plus vaccination in metastatic melanoma patients

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…

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

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.

In vivo identification of peripheral nerve bundles during surgery using optical spectroscopy techniques: a pilot study

With this pilot study we aim to prove that our optical spectroscopy system can provide accurate identification of nerve tissue during surgery.

Surgical excision versus Mohs*micrographic surgery for cutaneous Squamous Cell Carcinoma

There's alack of randomized controlled trials for the treatment of primary squamous cell carcinoma of the skin and randomized comparative studies are recommended. With this pilot study, we want to study the effectiveness of Mohs'…

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

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

An open-label, single arm, multi-centre, Phase II study to evaluate the safety and efficacy of PC-A11 with superficial and interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy.

*Run-in* part: The *run-in part* primary objective:• To determine a safe light dose for PC-A11 with interstitial laser light application in patients with recurrent head and neck squamous cell carcinoma unsuitable for surgery and radiotherapy and…

Determining the sensitivity and specificity of circulating tumor cells and cytology in cerebrospinal fluid of patients clinically suspected for leptomeningeal metastases

In the future, the determination of CTCs and ctDNA in the CSF could be a new quantitative method for the anti-tumor response assessment of systemic or intrathecal therapy (as opposed to CSF cytology, which is subjective and not a quantitative method…

COMBI-AD: A phase III randomized double blind study of dabrafenib (GSK2118436) in COMBInation with trametinib (GSK1120212) versus two placebos in the ADjuvant treatment of high-risk BRAF V600 mutation-positive melanoma after surgical resection (BRF115532)

Primary: efficacy of dabrafenib and trametinib combination therapy compared to placebo with respect to relapse-free survival in patients with completely resected, histologically confirmed, BRAF V600E/K high risk, stage III cutaneous melanoma.…

Treatment of superficial basal cell carcinoma by topical photodynamic therapy with fractionated 5-aminolevulinic acid 20% versus two stage topical photodynamic therapy with methylaminolevulinate

To compare effectiveness, costs and patient preferences in the treatment of sBCC with fractionated 5-ALA 20% PDT versus MAL PDT in 2 sessions.

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB (RO5185426) ADJUVANT THERAPY IN PATIENTS WITH SURGICALLY RESECTED, CUTANEOUS BRAF-MUTANT MELANOMA AT HIGH RISK FOR RECURRENCE

Primary ObjectiveThe primary objective of this study is as follows:* To evaluate the efficacy of vemurafenib adjuvant treatment administered over a 52-week period in patients with completely resected BRAFV600 mutation*positive, cutaneous melanoma,…

A Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to dabrafenib and placebo as first-line therapy in subjects with unresectable (Stage IIIc) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma (MEK115306)

Primary: superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib-placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-…

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…

Multicenter phase I/IIa study using T-cell receptor gene therapy in metastatic melanoma

To study the safety of the adoptive transfer of autologous T cells modified with a Mart-1 specific TCR in advanced stage (uveal) melanoma patients with disease progression upon standard cancer therapy. In addition, the toxicity according to CTC…

A phase III, randomised, open-label study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to the BRAF inhibitor vemurafenib in subjects with unresectable (stage IIIc) or metastatic (stage IV) BRAF V600E/K mutation positive cutaneous melanoma (MEK116513)

Primary: superiority of dabrafenib and trametinib combination therapy over vemurafenib monotherapy with respect to overall survival for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.Secondary: progression free…