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.

Recruitment status Open-label arm active
Study phase Phase II, Pivotal
Enrollment 201
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

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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.

Recruitment status Active, not recruiting
Study phase Phase II
Enrollment 21
Primary objective
  • to investigate the anti-tumor efficacy of domatinostat in combination with avelumab in advanced unresectable/metastatic MCC patients progressing on anti-PD-(L)1 antibody monotherapy.
Key secondary objective
  • to investigate safety, tolerability, pharmacokinetics, avelumab anti-drug antibodies (ADA) and health-related quality of life (HrQoL).

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