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A Randomised, Double-Blind Study to Assess the Efficacy of Selumetinib
(AZD6244, Hyd-Sulfate) in Combination with Dacarbazine Compared with
Placebo in Combination with Dacarbazine as First Systemic Therapy in
Patients with Metastatic Uveal Melanoma (SUMIT)

ObjectivesPrimary objective1. To assess the efficacy of selumetinib in combination with dacarbazine compared with placebo in combination with dacarbazine in terms of Progression Free Survival (PFS) assessed by blinded independent central review (…

Late effects of radiotherapy in patients with optic nerve sheath meningioma

Assessment of late effects of radiotherapy in patients with ONSM.

mRNA-transfected dendritic cell vaccination in high risk uveal melanoma patients

The primary goal is to show the capability of monocyte-derived DC after RNA electroporation for melanoma antigens to induce an immune response.The secondary objective is to show clinical response.

Phase Ib/II study exploring safety and efficacy of the combination of ipilimumab with radiofrequency ablation (RFA) in patients with unresectable uveal melanoma liver metastasis (SECIRA-UM)

To evaluate the safety and efficacy of the combination of RFA and Ipilimumab in patients with unresectable, pathologically confirmed hepatic metastases of uveal melanoma.

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 Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of
Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma

Primary: To determine the efficacy and safety of bel-sar compared to sham control for thetreatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).Secondary: To assess the systemic pharmacokinetics (PK) and immunogenicity of…

A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of
Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma

Primary: To determine the efficacy and safety of bel-sar compared to sham control for thetreatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).Secondary: To assess the systemic pharmacokinetics (PK) and immunogenicity of…

A Phase I/II, multi-center, open label study of DYP688 in patients with MUM and other GNAQ/11 mutant melanomas (study CDYP688A12101)

This study has been transitioned to CTIS with ID 2023-509451-14-00 check the CTIS register for the current data. Primary:Phase I: • To characterize the safety and tolerability and to identify the maximum tolerated dose (MTD) and/or recommended dose…

Anatomical stability during proton beam therapy of uveal melanoma

We aim to assess the stability of the ocular structures and tantalum clips during the complete PBT treatment, so no part of the tumour is missed during radiotherapy, to reduce the total burden for the patient.

A Phase I, multi-center, open-label, study of LXS196, an oral protein kinase C inhibitor, in patients with metastatic uveal melanoma

To characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of LXS196 as a single agent or LXS196 in combination with HDM201 in patients with metastatic uveal melanoma.

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator*s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma

The primary objective is to compare the OS in patients treated with IMCgp100 monotherapy versus Investigator*s Choice in HLA-A*0201 positive patients with advanced UM with no prior treatment in the metastatic setting. The secondary objectives of the…

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…