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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 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…

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.

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…

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…

Local immunotherapy by the synergism of monobenzone and imiquimod cream (MI) for cutaneous metastases in stage III-IV melanoma patients.

Primary Objective: • To study the clinical efficacy of local treatment with monobenzone and imiquimod cream on cutaneous metastases in stage III-IV melanoma patients Secondary Objective• To study the induction of local tumor-specific immunity by MI…

A phase II, randomized double-blind study of efficacy and safety of two dose levels of LDE225 in patients with locally advanced or metastatic basal cell carcinoma

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…

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.

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…

Cytoreductive treatment of dabrafenib combined with trametinib to allow complete surgical resection in patients with BRAF mutated, prior unresectable stage III or IV melanoma

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.

The TEAM trial (Tasigna efficacy in advanced melanoma): A
phase II, open label, multi-center, single-arm study to
assess the efficacy of Tasigna® in the treatment of patients
with metastatic and/or inoperable melanoma harboring a c-
Kit mutation

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…

A Single-Arm, Open-Label, Multicenter Clinical Trial with Nivolumab (BMS-
936558) for Subjects with Histologically Confirmed Stage III
(unresectable) or Stage IV Melanoma Progressing After Prior Treatment
Containing an Anti-CTLA-4 Monoclonal Antibody

The primary objective of this trial are:- To determine the incidence of high-grade (CTCAE v4.0 Grade 3 orhigher), treatment related, select adverse events in patients withhistologically confirmed stage III (unresectable) or stage IV melanomaand…

A phase II, open label study to investigate the efficacy and safety of domatinostat in combination with avelumab in patients with advanced unresectable/metastatic Merkel Cell Carcinoma progressing on anti-PD(L)1 antibody therapy - the MERKLIN 2 study

Objectives:Primary Objective: to investigate the anti-tumor efficacy of domatinostat in combination with avelumab in advanced unresectable/metastatic MCC patients progressing on anti-PD-(L)1 antibody monotherapy.Secondary Objectives: to investigate…

Prospective randomized trial of an adjuvant therapy of completely resected Merkel Cell Carcinoma (MCC) with immune checkpoint blocking antibodies (Nivolumab, Opdivo®; Ipilimumab, Yervoy®) versus observation

Primary objective:To estimate the efficacy of adjuvant nivolumab monotherapy in completely resected MCC patients; i.e. the primary endpoint is Disease-free survival (DFS) in arm A at 12 months, defined as the number of patients alive and free of…

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…

Phase 2 Study Comparing Pembrolizumab with Intermittent/Short-term Dual MAPK Pathway Inhibition Plus Pembrolizumab in patients harboring the BRAFV600 mutation (IMPemBra)

Primary objectives: To explore the safety, feasibility, and the immune-activating capacity of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapySecondary…

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…

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…