Ongoing and Planned Clinical Trials

– Please select –Ongoing / PlannedCompletedInvestigator-Sponsored Trials / Research

Ongoing

• RESMAIN – Resminostat versus placebo as maintenance therapy in cutaneous T cell lymphoma (CTCL)
• Resminostat plus S-1 in biliary tract cancer (BTC)
• SENSITIZE – Domatinostat + pembrolizumab (Keytruda^®) in patients with unresectable advanced-stage melanoma refractory or non-responding to prior anti-PD-1 treatment
• EMERGE – Domatinostat + avelumab (Bavencio^®) in microsatellite-stable gastrointestinal tumors (investigator-sponsored trial)

Planned

• MERKLIN 1 – Domatinostat in combination with a checkpoint inhibitor as first-line therapy in advanced-stage Merkel cell carcinoma
• MERKLIN 2 – Domatinostat in combination with a checkpoint inhibitor as second-line therapy in advanced-stage Merkel cell carcinoma
• DONIMI – Domatinostat in combination with a checkpoint inhibitor in the neo-adjuvant setting in melanoma (investigator-sponsored trial)
• “Triple Combo” – Domatinostat in combination with two checkpoint inhibitors in advanced-stage melanoma (investigator-sponsored trial)

RESMAIN – Resminostat versus placebo as maintenance therapy in cutaneous T‑cell lymphoma (CTCL)

NCT02953301

The pivotal RESMAIN study is a multi-national, multi-center, double-blind, randomized and placebo controlled study to evaluate resminostat for maintenance treatment of patients with advanced stage (Stage IIB‑IVB) Mycosis Fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy.

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Resminostat plus S-1 in biliary tract cancer (BTC)

This is a double-blind, randomized Phase II study to assess the efficacy of resminostat in combination with S-1 (experimental arm) compared to placebo in combination with S-1 (control arm) in patients with unresectable or platinum-gemcitabine combination refractory biliary tract cancer conducted by our cooperation partner Yakult Honsha.

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SENSITIZE – Domatinostat + pembrolizumab (Keytruda^®) in patients with unresectable advanced-stage melanoma refractory or non-responding to prior anti-PD-1 treatment

NCT03278665

The SENSITIZE study is an open-label, multi-center, Phase Ib/II study to evaluate the combination treatment of domatinostat with the anti-PD-1 antibody pembrolizumab (Keytruda^®) in patients suffering from advanced-stage cutaneous melanoma who are refractory or non-responding to prior treatment with anti-PD-1 antibodies.

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EMERGE – Domatinostat + avelumab (Bavencio^®) in microsatellite-stable gastrointestinal tumors

NCT03812796

The EMERGE study is an open-label, multi-center, Phase II study to evaluate the combination treatment of domatinostat with the anti-PD-L1 antibody avelumab (Bavencio^®) in patients suffering from microsatellite-stable esophago-gastric and colorectal (MSS-GI) cancer.  The investigator-sponsored study is conducted by Prof. David Cunningham from The Royal Marsden NHS Foundation Trust (London, UK).

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