NL-OMON51269尚未招募2 期
A phase II, open label, multicenter study to investigate the efficacy and safety of domatinostat in combination with avelumab in patients with treatment-naïve metastatic Merkel Cell Carcinoma - the MERKLIN 1 Study - MERKLIN 1
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 4SC AG
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Signed written informed consent.
- •2. Age > 18 years at signature of Informed Consent Form (ICF).
- •3. Histologically proven MCC.
- •Confirmation of the diagnosis by immune-histochemistry as per standard at the
- •institution, including (but not limited to) CK20 and TTF-1.
- •Patients must have metastatic or distally recurrent disease; M1 status must
- •be confirmed at entry.
- •Patients must not have received any prior systemic treatment for metastatic
- •MCC. Prior treatment in the adjuvant setting (no clinically detectable disease;
- •no metastatic disease) will be allowed, if the end of the treatment occurred at
- •least 6 months prior to study entry, i.e. signing ICF.
- •[Note: Not applicable for patients entering re-treatment (Section 4.4.1.1); in
- •case the patient is eligible for re-treatment as defined in this protocol, the
- •most recent treatment before re-treatment must be MERKLIN 1 study drug and no
- •other anti-tumor treatment is allowed since end of previous MERKLIN 1 treatment]
- •4. Fresh biopsy or archival tumor tissue (not older than 6 months) from an
- •unirradiated lesion.
- •[Note: No systemic anti-cancer treatment should have been given since archival
- •tumor tissue has been collected]
- •5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at
- •study entry.
- •6. Estimated life expectancy of more than 12 weeks.
- •7. Disease must be measurable with at least one unidimensional measurable
- •lesion by RECIST v1.1 (including skin lesions).
- •[Baseline imaging will be performed within 18 days prior to planned start of
- •the study treatment, if no RECIST v1.1 evaluable imaging was done within 4
- •weeks prior to the planned start of the study treatment.]
- •8. Adequate hematological and organ function defined by the following
- •parameters:
- •Adequate hematological function defined by
- •White blood cell count (WBC) > 3000/µl
- •Absolute Neutrophil Count (ANC) > 1500/µl
- •Lymphocyte count > 500/µl
- •Hemoglobin (Hb) > 9 g/dl (or > 5.6 mmol/L), may have been transfused
- •Platelet count > 100.000/µl
- •Adequate hepatic function defined by
- •Serum total bilirubin < 1.5 x ULN
- •ALT and/or AST < 1.5 x ULN
- •Adequate renal function defined by
- •eGFR > 60 ml/min (as per Cockcroft-Gault formula)
- •9. Highly effective contraception for both male and female subjects if the risk
- •of conception exists. Female patients of childbearing potential must have a
- •negative urine or serum pregnancy test before receiving the first dose of study
- •medication and must comply with contraception methods as requested by the study
排除标准
- •1. Participation in another interventional clinical study within the past 30
- •days (participation in observational studies is permitted)
- •[Note: A patient in the survival follow-up phase will be eligible.]
- •2. Concurrent treatment with a non-permitted drug
- •3. Prior therapy with any histone deacetylase (HDAC) inhibitor or antibody/drug
- •targeting T cell coregulatory proteins (immune checkpoints) such as
- •anti-programmed death 1 (PD-1), anti-programmed death-ligand 1 (PD-L1) or
- •anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody.
- •[Note: Not applicable for patients entering re-treatment (Section 4.4.1.1); in
- •case the patient is eligible for re-treatment as defined in this protocol, the
- •most recent treatment before re-treatment must be MERKLIN 1 study drug and no
- •other anti-tumor treatment is allowed since end of previous MERKLIN 1 treatment]
- •4. Concurrent anti-cancer treatment (for example, cytoreductive therapy,
- •radiotherapy [except for palliative bone directed radiotherapy, or radiotherapy
- •administered on non-target superficial lesions], immune therapy, or cytokine
- •therapy except for erythropoietin). Radiotherapy administered to superficial
- •lesions is not allowed if such lesions are considered target lesions in the
- •efficacy evaluation or may influence the efficacy evaluation of the study
- •5. Major surgery for any reason, except diagnostic biopsy, within 4 weeks
- •and/or if the subject has not fully recovered from surgery.
- •6. Concurrent systemic therapy with steroids or other immunosuppressive agents
- •(e.g. methotrexate, azathioprine, interferons, mycophenolate, anti-TNF agents
- •and other), or the use of any investigational drug within 28 days before the
- •start of study treatment. Short-term administration of systemic steroids e.g.
- •for allergic reactions or the management of immune-related adverse events
- •[irAE] while on study is allowed. Also, patients requiring hormone replacement
- •with corticosteroids for adrenal insufficiency are eligible if the steroids are
- •administered only for purpose of hormonal replacement and at doses < 10 mg or
- •equivalent prednisone per day.
- •[Note: Patients receiving bisphosphonate or denosumab are eligible.]
- •7. Conditions requiring systemic anti-arrhythmic therapy known to prolong
- •QT/QTc interval, patients with QTcF interval >480 msec on at least 2 separate
- •and consecutive ECGs at screening or a medical history of long-QT-Syndrome.
- •8. Patients with active central nervous system (CNS) metastases are excluded
- •and a brain CT/MRI will be required during screening if not performed within 6
- •weeks prior to the planned start of the study treatment. Subjects with a
- •history of treated CNS metastases (by surgery or radiation therapy) are not
- •eligible unless they have fully recovered from treatment, demonstrated no
- •progression for at least 2 months, and do not require continued steroid therapy.
- •9. History of or concurrent malignancies, except the malignancy is clinically
- •insignificant, no systemic treatment is or has been required for the last 6
- •months, and the patient is clinically stable
- •10. Prior organ transplantation (including allogeneic stem-cell
- •transplantation).
- •11. Any active gastrointestinal disorder that could interfere with the
- •absorption of domatinostat characterized by malabsorption or inability to
- •swallow tablets as per judgment o
研究者
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