Ongoing and Planned Clinical Trials
Ongoing
- RESMAIN – Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
- 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)
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.
| Recruitment status | Active, not recruiting |
| Study phase | Phase II |
| Enrollment | 201 |
| Primary objective |
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| Key secondary objective |
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EMERGE – Epigenetic Modulation of the immunE Response in GastrointEstinal Cancers (investigator-sponsored trial)
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).
| Recruitment status | Active, not recruiting |
| Study phase | Phase II |
| Enrollment | 29 |
| Primary objective |
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| Key secondary objectives |
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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)
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.
| Recruitment status | Acitve, not recruiting |
| Study phase | Phase Ib |
| Enrollment | 44 |
| Primary objective |
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| Key secondary objectives |
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MERKLIN 2 – Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1
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.
| Recruitment status | Active, not recruiting |
| Study phase | Phase II |
| Enrollment | 21 |
| Primary objective |
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| Key secondary objective |
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TURANDOT – Checkpoint Inhibition With or Without Domatinostat in Urothelial Cancer (investigator sponsored trial)
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.
| Recruitment status | Recruiting |
| Study phase | Phase Ib |
| Enrollment | 40 |
| Primary objective |
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| Key secondary objectives |
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