EUCTR2016-004461-47-DE进行中（未招募）1 期
A Phase 1b/2, Open-label, Multicenter, Dose-escalation andExpansion Trial of Intratumoral SD-101 in Combination WithPembrolizumab in Patients With Metastatic Melanoma or Recurrentor Metastatic Head and Neck Squamous Cell Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 235
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
- •Phase 1 study is completed.
- •A patient must meet all of the following criteria to be eligible for enrollment (defined as receiving the first trial treatment) [ie, pembrolizumab or SD-101]) in the trial:
- •Willing and able to provide written informed consent for the trial
- •Aged 18 years and older
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- •Patient must have adequate organ function as indicated by the following laboratory values:
- •Hematological
- •Absolute neutrophil count (ANC) = 1,500 /mcL
- •Platelet count = 100,000 /mcL
- •Hemoglobin = 9 g/dL or = 5.6 mmol/L
- •Serum creatinine = 1.5 × upper limit of normal (ULN) OR
- •Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) = 60 mL/min for subject with creatinine levels > 1.5 × institutional ULN
- •Serum total bilirubin:
- •= 1.5 × ULN OR
- •< 3 × ULN for persons with Gilbert’s syndrome OR
- •Direct bilirubin = ULN for patients with total bilirubin levels > 1.5 × ULN
- •Aspartate transaminase (AST) and alanine transaminase (ALT) (also known as serum glutamic oxaloacetic transaminase and serum glutamic
- •pyruvic transaminase)
- •= 2.5 × ULN OR
- •= 5 × ULN for patients with liver metastases
- •Coagulation
- •International normalized ratio or prothrombin time (PT) = 1.5 × ULN unless patient is receiving anticoagulant therapy, and as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
- •Activated partial thromboplastin time (aPTT) = 1.5 × ULN unless patient is receiving anticoagulant therapy, and as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- •Have provided 2 tissue biopsy samples taken as a single biopsy split into 2 samples or 2 separate biopsies that meet the minimal sample size requirement per the study laboratory manual. One sample is for determining PD-L1 expression level by immunohistochemistry and can be an archival sample that has been collected within 3 months of screening. The other sample is for RNA expression profiling and must be a fresh biopsy.
- •Life expectancy of at least 6 months
- •Female patients of childbearing potential, as defined in this protocol, must have a negative urine or serum pregnancy test within 72 hours prior to taking the first dose of trial treatment. Male patient of reproductive potential must agree to use an adequate method of contraception from Day 1 through 120 days after the last dose of trial treatment.
- •Inclusion Criteria (Phase 2 only: Melanoma)
- •A patient must meet the following to be eligible for Phase 2 (as applicable to the expansion cohorts):
- •Histologically or cytologically confirmed recurrent or unresectable or metastatic (stage IV) melanoma
- •Must have at least 2 lesions that qualify as a target lesion per RECIST v1.1, and 1 of the qualifying lesions must be easily accessible (palpable or can be visualized by ultrasound) and amenable to multiple intratumoral injections. The target lesion should be of sufficient size such that the required tumor biopsies do not significantly affect tumor assessment per RECIST v1.1.
- •Expansion Cohort 2: Must have documented PD per RECIST v1.1 on a prior treatment regimen containing an anti-PD-1/L1 drug.
- •Expansion Cohort 8: Must have all of the following:
- •a) Received at least 2 doses of an anti-PD-1/L1 therapy, where the last dose of anti-PD-1/L1 therapy was within
排除标准
- •A patient with any 1 of the following criteria is not eligible for enrollment in the trial:
- •Received systemic chemotherapy or biological cancer therapy (except anti-PD-1/L1 therapy) within 3 weeks prior to study enrollment
- •Received prior radiotherapy within 2 weeks of start of study therapy. A shorter washout period may be permitted after approval by the Medical Monitor.
- •Received small molecule inhibitor targeted therapy, such as tyrosine kinase inhibitors, within 2 weeks prior to study enrollment
- •Has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the AEs due to cancer therapeutics prior to study enrollment
- •Received a transfusion of blood products (including platelets or red blood cells) or colony-stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to study enrollment
- •Is expected to require any other form of anti-cancer therapy while in the trial
- •Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy (including immune modulators or systemic corticosteroids) within 7 days prior to study enrollment
- •Positive for active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection as determined by laboratory tests for HBsAg, anti-HBc, and anti-HBs; anti-HCV; and anti-HIV -1/2, respectively
- •History of or current uveal or ocular or mucosal melanoma
- •Active infection including cytomegalovirus
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of trial treatment
- •Active autoimmune disease requiring systemic treatment in the past 2 years or a disease that requires immunosuppressive medication including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, or autoimmune thrombocytopenia. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- •Current pneumonitis or history of (non-infectious) pneumonitis that required Steroids
- •An immune-related AE from a previous immunotherapeutic agent that has not resolved to Grade 1 or less prior to study enrollment. The exception is a Grade 2 AE which qualifies as Grade 2 due to replacement steroid therapy which may be allowed with approval by a Dynavax Medical Monitor.
- •Known active central nervous system metastases or carcinomatous meningitis
- •Use of any investigational agent within the last 28 days prior to study enrollment
- •Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- •Any other significant medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with trial participation or trial drug administration that may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for this trial
- •History of sensitivity to any component of SD-101 or hypersensitivity reaction to treatment with a monoclonal antibody and/or any of its excipients
- •Any known additional malignancy that is progressing or requires active treatment. Exceptions are cutaneous melanoma or HNSCC under study per
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