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A phase II, open label, multicenter study to investigate the efficacy and safety of domatinostat in combination with avelumab in patients with treatment-naïve metastatic Merkel Cell Carcinoma - the MERKLIN 1 Study

Primary Objective: to evaluate clinical efficacy of domatinostat in combination with avelumab in treatment-naïve metastatic or distally recurrent MCC patients as determined by the Objective Response Rate (ORR) according to Response Evaluation…

Patient reported outcomes in high risk and advanced melanoma patients

Primary outcome is to assess HRQoL in high risk and advanced melanoma patients treated with immune checkpoint-inhibitors. Secondary outcomes are to describe anxiety and depression; fear of cancer recurrence; melanoma-specific HRQoL; symptoms and…

A phase Ib/II randomized double-blind placebo controlled trial evaluating the effect of Nivolumab for patients with in-transit melanoma metastases treated with isolated limb perfusion (NivoILP trial)

This study has been transitioned to CTIS with ID 2023-509265-21-00 check the CTIS register for the current data. To evaluate safety and the effect of isolated limb perfusion together with nivolumab as a way to increase efficacy and give further…

Open Label Phase 2 Study
Neo-Adjuvant BRAF/MEK Inhibition Followed by Surgery and Adjuvant BRAF/MEK Inhibition in In-transit Melanoma Metastases (NASAM)

Encorafenib/binimetinb combination therapy can possibly reduce tumor size and thus making surgical treatment less comprehensive. In addition, the treatment can potentially improve recurrence-free survival, overall survival, and distant metastases-…

Adjuvant encorafenib & binimetinib vs. placebo in fully resected stage IIB/C BRAF V600E/K mutated melanoma: a randomized triple-blind phase III study in collaboration with the EORTC Melanoma Group

To characterize the safety and tolerability.1. To describe the available RFS data by treatment arm.2. To describe the available DMFS data by treatment arm.3. To describe-reported health-related quality of life (HRQoL) bytreatment arm.

Additional value of 18F-FDG PET-MRI in patients with melanoma

Primary Objectives- To investigate the impact of dose reduction of 18F-FDG on image quality of PET-MRII in patients with melanoma. Secondary Objectives- To determine the maximum reduction of radiation dose for 18F-FDG PET-MRI as compared to…

Role of host cell DNA methylation analysis in predicting non-regression or regression of high-grade anal intraepithelial neoplasia in HIV+ men trial (MARINE)

In this study we clinically validate if host cell DNA methylation markers can predict (non-)regression of HGAIN, thus determining the need of immediate treatment versus active surveillance and the safety of withholding treatment. This could prevent…

A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE TREATMENT COMBINATIONS IN PATIENTS WITH MELANOMA (MORPHEUS-MELANOMA)

• To evaluate the efficacy of treatment• To evaluate the safety of treatment

A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT)M erkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients Who Are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

Primary Objectives- Cohort 1 Part 1: To determine the KRT-232 recommended phase 2 dose (RP2D)- Cohort 1 Part 2: To determine the objective response rate (ORR) in subjects with p53WT MCC who have failed anti-PD-1 or anti-PD-L1 immunotherapy- Cohort 2…

Detection of recirculating tumor-associated tissue macrophages and circulating melanoma cells as a tool for monitoring melanoma patients: a pilot study.

Primary Objective: - Investigate whether recirculating tumor-associated tissue macrophages (TiMas), as well as circulating melanoma cells can be detected using high-end flow cytometry methods in peripheral blood from melanoma patients.Secondary…

Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab in macroscopic stage III melanoma - NADINA

This study has been transitioned to CTIS with ID 2024-513519-28-00 check the CTIS register for the current data. Primary objective • To compare the event-free survival (EFS) of neoadjuvant ipilimumab + nivolumab (followed by adjuvant nivolumab or…

Nivolumab dose optimization during nivolumab therapy in melanoma patients after achieving a complete, partial or stable response (NIVOPTIMIZE-trial)

This study has been transitioned to CTIS with ID 2024-516718-39-00 check the CTIS register for the current data. The primary objective is to demonstrate that the nivolumab steady-state level after 3 cycles with a reduced nivolumab dosage (240 mg…

Exploring an alternative pre-operative sentinel lymph node mapping method using a Magnetic tracer and MRI for melanoma patients

The primary objective of this study is to evaluate the feasibility and diagnostic accuracy of pre-operative MRI scanning using SPIO compared to lymphoscintigraphy (LS) and single-photon emission computed tomography/computed tomography (SPECT/CT)…

Exploring an alternative pre-operative sentinel lymph node mapping method using a Magnetic tracer and MRI for potential use in melanoma patients: Imaging subprotocol in healthy participants

The primary objective of this study, including healthy subjects, is to develop a pre-operative MRI protocol for the localization of SLNs in melanoma patients. Acquired knowledge will serve to design a feasibility study, including a larger group of…