EUCTR2017-001050-33-DE进行中（未招募）1 期
An open-label Phase Ib/ II, multi-center study of 4SC-202 in Combination with Pembrolizumab in Patients with Unresectable Stage III/Metastatic Stage IV Cutaneous Melanoma primary refractory/non-responding to prior Anti-PD-1 Therapy – The SENSITIZE Study - SENSITIZE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 4SC AG
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All inclusion criteria must be met during screening, unless otherwise stated.
- •Signed informed consent must be obtained prior to any study specific procedure.
- •1. Male or female patients, age = 18 years (at screening)
- •2. ECOG PS 0-1
- •3. Patients with unresectable stage III or stage IV cutaneous melanoma, as per AJCC (Version 7 or 8) staging system (must have been histologically confirmed at least once during course of disease)
- •4. Patients with metastatic tumor of unknown primary site and histology of melanoma are eligible
- •5. Patients must be primary refractory or non-responding to anti-PD-1 therapy (either as monotherapy or in combination with Ipilimumab)
- •The following definitions apply:
- •I. Primary refractory: Patients not achieving a response of CR, PR or SD (i.e. not achieving disease control)
- •II. Non-responding: Patients not having achieved a response of CR or PR but having achieved SD
- •6. Patients must have progressed during anti-PD-1 mono therapy or Ipilimumab/anti-PD-1 combination therapy, and within 6 months after the last dose of either Nivolumab or Pembrolizumab
- •7. Patients must have had anti-PD-1 mono therapy or Ipilimumab/anti-PD-1 combination therapy as the last systemic cancer directed treatment consisting of at least two administrations of either Nivolumab or Pembrolizumab and must have received the last anti-PD-1 administration within 6 months prior to ICF signature
- •8. Patients must have been tested for BRAF V600 mutation status
- •9. Patients with BRAF-mutated melanoma must have had a BRAF-mutation directed therapy, unless they were not considered eligible (e.g. due to contraindications) to such treatment
- •10. Measurable disease by CT or MRI per irRECIST 1.1 criteria, with longest diameter for non-nodal lesions = 10 mm and = 15 mm in short axis for nodal lesions
- •11. At least one tumor site (either primary site or metastasis) must be accessible for sequential biopsies and patient must consent to the 2 mandatory biopsies. This requirement may be waived by the sponsor in individual cases. [Note: Applicable in dose levels 1, 2a, 3 and 4; biopsies in dose level 2b were only optional]
- •12. Females of Childbearing Potential must agree to use highly effective contraception from screening to at least four months after the last dose of Pembrolizumab or 4SC-202 (whatever is later)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Patients not consenting to use adequate contraception as required per protocol.
- •2. Patients currently participating or who have participated in a study of an investigational agent or who are using an investigational device or have done so within 28 days of the first dose of study drug. A patient in the Survival Follow-up phase of an investigational agent where no further treatment is expected is eligible
- •3. Patients who achieved a CR or PR, during or after prior anti-PD-1 mono or anti CTLA-4/anti-PD-1 combination therapy
- •4. Life expectancy below 3 months
- •5. Patients with uveal or mucosal melanoma
- •6. Patients with symptomatic brain metastases/CNS involvement
- •7. Patients with inadequate organ function, defined as:
- •a) Absolute neutrophil count (ANC) < 1500/µL
- •b) Hemoglobin (Hb) < 9 g/dL
- •c) Platelet count < 100,000/µL
- •d) Potassium outside of normal limits and not correctable with supplements
- •e) Serum creatinine > 1.5 x ULN or eGFR < 50 mL/min (as per Cockroft-Gault formula).
- •f) ALT and/or AST > 2.5 x ULN .
- •g) Serum total bilirubin > 1.5 x ULN.
- •h) LDH > 5 x ULN.
- •8. Remaining relevant toxicity (excluding alopecia, fatigue) to previous therapy has not resolved to Grade 1 (applicable at screening)
- •9. Patients with a history of anti-PD-1 / immune-related adverse drug reactions of Grade 4 or Grade 3 and a high risk of re-occurrence (as judged by the investigator)
- •10. Prior treatment with a HDAC or LSD1 inhibitor or both
- •11. Prior treatment with anti-PD-L1 or anti-PD-L2 agents (prior treatment with anti-CTLA-4 agents is allowed)
- •12. Patients with precedent systemic anti-cancer therapy including chemotherapy, endocrine therapy, immunotherapy or use of other investigational agents prior first study drug administration.
- •13. Therapy with agents known to prolong the QT interval and increase the risk for Torsades de Pointes, such as certain antibiotics (i.e. erythromycin, clarithromycin), antidepressants (i.e. doxepin, amitryptilin) or neuroleptics (i.e. haloperidol, clozapin)
- •14. Patients who have received a live vaccine within 28 days prior to anticipated first dose of study drug.
- •15. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications (e.g. methotrexate, azathioprine, mTOR inhibitors, Interferons, mycophenolate, anti-TNF agents, and other) within 14 days of study drug administration.
- •16. Patients with any immunodeficiency disorder
- •17. Patients with any active, known or suspected autoimmune disease that might deteriorate when receiving an immunostimulatory agent as judged by the investigator
- •18. Patients with a marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >450 msec (Grade 1 NCI-CTCAE); Long-QT-Syndrome (QTcF is applicable)
- •19. Patients with any active gastrointestinal disorder that could interfere with the absorption of 4SC-202 (as per judgement of the investigator), such as ulcerative colitis, Crohn’s disease, diabetic gastroparesis, or other syndromes characterized by malabsorption
- •20. Patients who are unable to take oral medication
- •21. Patients with a history of or concurrent other malignancies that require active, systemic anti-cancer treatment. Note: Patients with ongoing hormonal treatment of prostate, breast or others cancers are excluded even if the cancer has been removed in a curative extent.
- •22. Patients with any other medical, psychiatric or social condition, which i
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