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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…

Neo-adjuvant T-VEC + Nivolumab combination therapy for resectable early metastatic (stage IIIB/C/D-IV M1a) melanoma with injectable disease.

Primary objective:- To investigate if neo-adjuvant combination of talimogene laherparepvec and nivolumab will achieve a pathologic response rate of 45% complete responses (either *pathological complete response (pCR)* or *pathological near complete…

Neo-adjuvant nivolumab or nivolumab with ipilimumab in advanced cutaneous squamous cell carcinoma patients prior to standard of care surgery; the MATISSE trial

Herewith, we present a research protocol for a phase II trial that allows us to examine the efficacy (histopathological response rate) of ICI in the form of nivolumab or nivolumab plus ipilimumab prior to SOC in patients with resectable stage III-…

AN OPEN-LABEL, PHASE I STUDY OF NEO-PTC-01 IN PATIENTS WITH ADVANCED OR METASTATIC MELANOMA

This study has been transitioned to CTIS with ID 2023-508524-35-00 check the CTIS register for the current data. The primary objective of this study are 1) to evaluate the safety and determine the highest tolerable dose of NEO-PTC-01 in patients…

Prospective registration study on the sentinel node procedure for bulky squamous cell carcinoma of the nasal vestibule

To prospectively document the introduction of the sentinel node procedure for bulky cT1-T2N0 nasal vestibule carcinoma in patients at risk of nodal involvement.

Added value of OCT for diagnosing recurrent BCC after non-invasive treatment

To investigate the added value of OCT as a non-invasive tool for the diagnosis of recurrent BCC.

A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

The primary objective is to compare the efficacy, as measured by recurrence-free survival (RFS) by blinded independent central review (BICR), of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA (lymph…

Quality of life research among melanoma patients that have been treated with immunotherapy, or targeted therapy and/or surgery

This study will evaluate Health-Related Quality of Life (general and disease specific), socio-demographic data, anxiety, depression, fear for cancer recurrence, immunotherapy related discomforts, sexual health, social functioning (work ability),…

Fluorescent Guided Surgery in Penile Carcinoma using Cetuximab-800CW

The purpose of the current study is to determine the feasibility of using MFGS using Cetuximab-800CW as an intraoperative margin assessment tool for penile carcinoma.

The Feasibility of Multispectral Optoacoustic Tomography in different diseases: a phase 1 explorative imaging study

- The technical feasibility of multispectral optoacoustic tomography for the localization and assessment of disease-specific tissue in a particular anatomical area- Detection of endogenous biomarkers for the characterization in a variety of diseases

A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects with Gorlin Syndrome (Basal Cell Nevus Syndrome)

Primary Objective*To assess the safety and tolerability of Patidegib Topical Gel, 2% inpatients who have completed PellePharm Study Pelle-926-201 or Pelle-926-301Secondary Objectives*To assess the efficacy of Patidegib Topical Gel, 2% in patients…

PET/CT Robustness In Melanoma

Determining the robustness of [18F]-FDG PET/CT based quantitative features in metastatic melanoma patients by test-retesting [18F]-FDG PET/CT scans and varying post processing scan settings, for future diagnostic and prognostic clinical application.

A randomized, open-label, multi-arm, two-part, phase II study to assess the efficacy and safety of multiple LXH254 combinations in patients with previously treated unresectable or metastatic BRAFV600 or NRAS mutant melanoma

Primary objective of this study: evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR) by local investigator's assessment per RECIST v1.1secondary objectives: - Safety & tolerability of…