Ongoing and Planned Clinical Trials
Ongoing
- RESMAIN – Resminostat versus placebo as maintenance therapy in cutaneous T cell lymphoma (CTCL)
- 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)
- DONIMI – Domatinostat in combination with a checkpoint inhibitor in the neo-adjuvant setting in melanoma (investigator-sponsored trial)
- MERKLIN 2 – Domatinostat in combination with a checkpoint inhibitor as second-line therapy in advanced-stage Merkel cell carcinoma
Planned
- MERKLIN 1 – Domatinostat in combination with a checkpoint inhibitor as first-line therapy in advanced-stage Merkel cell carcinoma
- “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)
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 | Recruiting |
| Study phase | Phase II |
| Enrollment | 190 |
| Primary objective |
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| Key secondary objective |
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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
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.
| Recruitment status | Recruiting |
| Study phase | Phase Ib/II |
| Enrollment | 40 |
| Primary objective |
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| Key secondary objectives |
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| Exploratory objective |
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EMERGE – Domatinostat + avelumab (Bavencio®) in microsatellite-stable gastrointestinal tumors
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 | Recruiting |
| Study phase | Phase II |
| Enrollment | 84 |
| Primary objective |
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| Key secondary objectives |
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DONIMI – Domatinostat in combination with a checkpoint inhibitor in the neo-adjuvant setting in melanoma
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, Staff Member at the Department of Medical Oncology, and Group Leader at the Division of Immunology, The Netherlands Cancer Institute, Amsterdam.
| Recruitment status | Recruiting |
| Study phase | Phase Ib |
| Enrollment | 45 |
| Primary objective |
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| Key secondary objectives |
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MERKLIN 2 – Domatinostat in combination with a checkpoint inhibitor as second-line therapy in advanced-stage Merkel cell carcinoma
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 | Recruiting |
| Study phase | Phase II |
| Enrollment | 40 |
| Primary objective |
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| Key secondary objective |
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