Ongoing and Planned Clinical Trials

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

Ongoing

• RESMAIN – Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
• SENSITIZE – Domatinostat in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy
• EMERGE – Epigenetic Modulation of the immunE Response in GastrointEstinal Cancers (investigator-sponsored trial)
• DONIMI – Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma (investigator-sponsored trial)
• MERKLIN 2 – Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1
• TURANDOT – Checkpoint Inhibition With or Without Domatinostat in Urothelial Cancer (investigator sponsored trial) 

RESMAIN – Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)

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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SENSITIZE – Domatinostat in Combination With Pembrolizumab in Patients Primary Refractory/Non-responding to Prior Anti-PD-1 Therapy

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 – Epigenetic Modulation of the immunE Response in GastrointEstinal Cancers (investigator-sponsored trial)

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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DONIMI – Multicenter Phase 1b Trial Testing the Neoadjuvant Combination of Domatinostat, Nivolumab and Ipilimumab in IFN-gamma Signature-low and IFN-gamma Signature-high RECIST 1.1-measurable Stage III Cutaneous or Unknown Primary Melanoma (investigator-sponsored trial)

NCT04133948

The multicenter phase 1b study DONIMI is testing the combination of domatinostat, nivolumab, and ipilimumab, in high risk stage III melanoma in the neoadjuvant setting. The investigator-sponsored study is conducted by Prof. Christian Blank, MD, Medical Oncologyst, and Group Leader at the Division of Immunology, The Netherlands Cancer Institute, Amsterdam.

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MERKLIN 2 – Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1

NCT04393753

The MERKLIN 2 study is a Phase II clinical study evaluating domatinostat in combination with avelumab in patients with advanced MCC whose disease has progressed on anti-PD-(L)1 antibody therapy.

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TURANDOT – Checkpoint Inhibition With or Without Domatinostat in Urothelial Cancer (investigator sponsored trial)

NCT04871594

The multicenter phase 1b study TURANDOT is testing the combination of domatinostat, nivolumab, and ipilimumab, in high risk stage II-III urothelial cancer in the neoadjuvant setting. The investigator-sponsored study is conducted by Prof. Michiel S. van der Heijden, MD, Medical oncologist and Group Leader at The Netherlands Cancer Institute, Amsterdam.

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