Ongoing and Planned Clinical Trials

Ongoing

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
  • “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.

Recruitment status Recruiting
Study phase Phase II
Enrollment 190
Primary objective
  • Determine whether maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB IVB) MF or SS that have achieved disease control (complete response (CR), partial response (PR) or stable disease (SD)) with previous systemic therapy
Key secondary objective
  • Determine whether maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo

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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.

Recruitment status Recruiting
Study phase Phase Ib/II
Enrollment 40
Primary objective
  • Determine the safety and tolerability of domatinostat in combination with pembrolizumab
Key secondary objectives
  • Objective response rate (ORR)
  • Best overall response (BOR)
  • Disease control rate (DCR)
  • Duration of response (DOR)
  • Progression free survival (PFS)
  • Overall survival (OS)
Exploratory objective
  • Comprehensive biomarker program

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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).

Recruitment status Recruiting
Study phase Phase II
Enrollment 84
Primary objective
  • Determine the safety, tolerability and efficacy of domatinostat in combination with avelumab
Key secondary objectives
  • Duration of objective response (DoOR)
  • Progression free survival (PFS)
  • Overall survival (OS)
  • Disease control rate (DCR)

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DONIMI – Domatinostat in combination with a checkpoint inhibitor in the neo-adjuvant setting in melanoma

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, 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
  • To determine the safety and feasibility of neoadjuvant nivolumab +/- ipilimumab +/- domatinostat.
Key secondary objectives
  • Pathologic response rates (pCR, near pCR, pPR)
  • Frequency of treatment-related adverse events (safety)
  • Radiologic response rates acc. to RECIST 1.1
  • Relapse free survival (RFS)
  • Identification of biomarkers predictive for response to combination treatment
  • Evaluation of health-related quality of life
  • Analysis of fecal microbiome

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