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Longterm carcinogenic effects of daily low emission phototherapy in psoriasis

To ascertain the amount of UV-damage (p53 activation, apoptosis, thymidine dimers and γH2AX) is caused by the Dermasun treatment in psoriasis patients.Total skin check in patients using Dermasun for a prolonged period of time to screen for (pre-)…

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…

A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CA209-76K)

This study has been transitioned to CTIS with ID 2022-502354-14-00 check the CTIS register for the current data. Primary Objective:To measure the efficacy provided by nivolumab therapy on its own compared to placebo in participants who have had…

Adoptive therapy with TCR gene-engineered T cells to treat patients with MAGE-C2-positive melanoma and head and neck cancer.

This study has been transitioned to CTIS with ID 2024-516922-70-00 check the CTIS register for the current data. Phase I• Primary objectives:o To study the safety and feasibility of AT with autologous MC2 TCR T cells, combined with epigenetic drug…

A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma

This study has been transitioned to CTIS with ID 2023-509461-20-00 check the CTIS register for the current data. The primary objective is to investigate if IMO-2125 is capable of a) lowering the number of tumor positive SLN and b) inducing a loco-…

Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy

Primary objective:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab as assessed by objective response rate (ORR) in subjects with unresectable/metastatic stage IIIB-IVM1d melanoma who have progressed on prior…

Safety of topical 5-FU cream in patients carrying a clinically relevant DPYD variant

To study if patients who carry clinically relevant DPYD variants (DPYD*2A, DPYD*7, c.2846A>T, c.1236G>A/HapB3, c.1679T>G) are at a higher risk for developing severe 5-FU cream-related toxicity.

Chronic stress and Responsiveness to Immunotherapy for Metastasized Melanoma

The present pilot study will examine whether chronic stress is related to response to immunotherapy with checkpoint inhibitors for metastasized melanoma. Stress will be assesed by Hair cortisol, Salivary cortisol and some validated questionnaires (…

Multicenter Phase 1b trial testing the Neoadjuvant Combination of Domatinostat, Nivolumab, and Ipilimumab, in IFN-gamma signature-low and IFN-gamma signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma -DONIMI.

Primary objectives: - To assess safety and feasibility of neoadjuvant nivolumab +/- domatinostat +/- ipilimumab- To identify pathologic response rates of nivolumab +/- domatinostat +/- ipilimumabSecondary objectives: - To describe all grade…

An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered with Encorafenib and Binimetinib in Patients with BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors

The main purpose of this study is to assess investigate the effect of encorafenib and binimetinib (the study drugs) on the activity of other common drugs and the effect of modafinil on the activity of encorafenib. The study will also look at the…

Surgical excision versus photodynamic therapy and topical 5-fluorouracil in treatment of Bowen*s disease: a multicenter randomized controlled trial

Primary Objective: To determine the (cost)effectiveness of 5-fluorouracil cream (5FU) and photodynamic therapy (PDT), compared to surgical excision (SE) in Bowen*s Disease (BD).Secondary Objectives: To determine the (cost)effectiveness of 5-…

A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis

Primary ObjectiveSafety Lead-in* Evaluate the safety of a high-dose regimen of encorafenib + binimetinib combination therapy in patients with BRAFV600-mutant melanoma who have asymptomatic brain metastasisPhase 2If the high-dose regimen is…

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…

Image guided surgery for margin assessment of cutaneous squamous cell carcinoma during surgery: a phase I proof of concept study

The main purpose of this pilot study is to investigate the feasibility of fluorescence imaging using cetuximab-IRDye800CW for intraoperative margin assessment in patients with cutaneous squamous cell carcinoma.