EUCTR2015-002971-12-IT进行中（未招募）1 期
A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacyof IMCgp100 in Combination with Durvalumab (MEDI4736) orTremelimumab or the Combination of Durvalumab and TremelimumabCompared to IMCgp100 Alone in Patients with Advanced Melanoma - A study to test if IMCgp100 in combination with Durvalumab or Tremelimumab or the combination of Dur
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
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
- •1. Age = 18 years
- •2. Written informed consent must be obtained from all patients prior to any study procedures.
- •3. Patients with advanced non-uveal melanoma defined as unresectable Stage III or metastatic Stage IV disease. Patients with acral or mucosal melanoma are acceptable. Patients with melanoma of unknown primary source are acceptable for Phase Ib cohorts (Arms 1 to 4), but are excluded in Phase II cohorts. Patients with the diagnosis of uveal melanoma are excluded from all cohorts
- •4. Phase Ib Arm 4 and Phase II: Patients with disease progression following initiation of treatment with an approved PD-1 inhibitor. No prior cytotoxic therapy in the advanced setting is permitted. Patients
- •with BRAF mutations must be refractory to approved BRAF-based therapy. CTLA-4-inhibition therapy is acceptable as a prior line of therapy or in combination with anti-PD-1 therapy
- •5. Note: intentionally left blank by Sponsor in order to align with Protocol revision.
- •6. Phase Ib Arms 1, 2 and 3: no restriction on prior therapy
- •7. Human leukocyte antigen-A*0201 (HLA- A*0201) positive
- •8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •9. Life expectancy of at least 3 months
- •10. Phase II cohorts only: patients must have measurable disease according to RECIST v.1.1 criteria. Patients enrolled in Phase Ib cohorts must have evaluable disease
- •11. Phase Ib Arm 4 and Phase II cohorts only: Patients must have a site of disease amenable to biopsy that is not an index lesion, and be a candidate for tumor biopsy according to the treating institution's guidelines. Phase Ib Arms 1-3 patients need not have disease accessible to biopsy
- •12. Those receiving prior immunotherapy must meet all of the following conditions:
- •-Must not have experienced an immune-related adverse event(irAE) which was the reason for permanent discontinuation of prior immunotherapy in the most recent prior treatment regimen.
- •- All irAEs while receiving prior immunotherapy must have resolved to = grade 1 or Baseline prior to Screening for this study. Must not have experienced a = grade 3 immune-related AE within the past 16 weeks or any grade 4 life-threatening AE (regardless of duration) or neurologic or ocular AE of any grade while receiving prior immunotherapy. (NOTE:
- •Patients with endocrine AE of any grade are permitted to enroll if they are stably maintained on appropriate replacement therapy, but must have no history of adrenal crisis and be asymptomatic)
- •- Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged
- •- Patients currently receiving chronic corticosteroid treatment (longer than 8 weeks duration) for management of pre-existing adverse events, or patients with a history of chronic corticosteroid treatment longer than 8 weeks’ duration for adverse events within 6 months of Screening are excluded
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •1. Presence of untreated or symptomatic central nervous system metastases, or central nervous system metastases that currently require local therapy (such as radiotherapy or surgery), or require doses of corticosteroids within the prior 4 weeks.
- •2. History of severe hypersensitivity reactions to other monoclonal antibodies (mAb)s.
- •3. History of treatment-related interstitial lung disease/pneumonitis.
- •4. Patient with any out of range laboratory values.
- •Serum creatinine > 1.5 x ULN and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/min
- •Total bilirubin > 1.5 x upper limit of normal (ULN), except for patients with Gilbert’s syndrome who are excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN
- •Alanine aminotransferase (ALT) > 3 x ULN
- •Aspartate aminotransferase (AST) > 3 x ULN
- •Absolute neutrophil count (ANC) < 1.0 x 109/L
- •Absolute lymphocyte count < 0.5 x 109/L
- •Platelet count < 75 x 109/L
- •Hemoglobin (Hgb) < 8 g/dL
- •Potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events, (CTCAE) > grade 1
- •5. Clinically significant cardiac disease or impaired cardiac function.
- •Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association NYHA grade = 2), uncontrolled hypertension or clinically significant arrhythmia currently requiring medical treatment
- •QTcF >470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome
- •Acute myocardial infarction or unstable angina pectoris < 6 months prior to Screening
- •6. Active autoimmune disease or a documented history of autoimmune disease within 3 years before Screening (or as indicated below), including the following:
- •A documented history of inflammatory bowel disease (ulcerative colitis or Crohn’s disease, within 3 years)
- •Patients with vitiligo, alopecia, managed hypothyroidism (on stable replacement doses), psoriasis, resolved childhood asthma/atopy, well-controlled asthma and type I diabetes mellitus are NOT excluded
- •7. Recent (< 12 months) active diverticulitis (PhIb combination arms and PhII only)
- •8. Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy before Screening is initiated.
- •9. Known history of human immunodeficiency virus (HIV) infection.
- •10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, currently requiring medical intervention, per institutional protocol.
- •11. Malignant disease, other than that being treated in this study.
- •12. Any medical condition that would, in the investigator’s judgment, prevent the patient’s participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
- •13. Systemic anti-cancer therapy within 2 weeks of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity and any prior immunotherapy approach, 4 weeks is indicated as washout period.
- •14. Presence of NCI CTCAE = grade 2 toxicity (except alopecia, peripheral neuropathy and ototoxicity, which are excluded if = NCI CTCAE grade 3) due to prior cancer therapy.
- •15. Chronic, systemic corticosteroid use
- •16. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.
- •17. Major surgery as defined by the investigator within 2 weeks of the first dose o
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