CompletedPhase 1

IKKb-matured, RNA-loaded Dendritic Cells for Metastasised Uveal Melanoma

Germany17 participantsStarted 2020-09-24

Plain-language summary

A Phase I vaccination trial in patients suffering from recently diagnosed metastatic uveal melanoma not cureable with local therapy and needing systemic therapy. IKKb-matured Dendritic Cells loaded with autologous tumor-RNA + RNA coding for defined antigens and driver mutations will be added to a standard therapy chosen by the tumor board (either checkpoint blockade or chemotherapy).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: * Histologically confirmed unresectable stage IV metastatic uveal melanoma as per AJCC staging system 2014, 7th edition (updated 2018) not curable with local therapy modalities * WHO performance status of 0, 1 or 2 * age from 18 and ≤ 75 years * negative pregnancy test * signed informed consent Exclusion Criteria: * Major serious illness * evidence for HIV-1, HIV-2, HTLV-1, HBV or HCV infection * active autoimmune disease requiring immunosuppressive therapy * splenectomy or radiation therapy of the spleen * organ allografts * pregnancy * lactation * psychiatric disorders * severe organic brain syndrome

What they're measuring

Safety of DCIKKb

Timeframe: 1 year

Tolerability of DCIKKb

Timeframe: 1 year

Dose-limiting toxicities (DLTs) of DCIKKb

Timeframe: 1 year

Maximum tolerated dose (MTD) of DCIKKb

Timeframe: 1 year

Trial details

NCT IDNCT04335890

SponsorHasumi International Research Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-20

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