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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 (…

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.

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…

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…