NL-OMON49074招募中2 期
eo-adjuvant T-VEC + Nivolumab combination therapy for resectable early metastatic (stage IIIB/C/D-IV M1a) melanoma with injectable disease. - NIVEC
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
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
- •- Adults at least 18 years of age.
- •- WHO performance score of 0 or 1.
- •- Cytologically or histologically confirmed diagnosis of stage IIIB/C/D/IVM1a
- •(AJCC 8th edition) melanoma, eligible for surgical resection.
- •- Subjects must have measurable disease according to RECIST 1.1 and must be a
- •candidate for intralesional therapy with at least one injectable cutaneous,
- •subcutaneous or nodal melanoma lesion (>= 10 mm in longest diameter) or with
- •multiple injectable lesions that in aggregate have a longest diameter of >= 10
- •- Prior isolated limb perfusion (ILP) is allowed (>= 12 weeks prior to
- •enrollment).
- •- Screening laboratory values must meet the following criteria: - WBC >=
- •2.0x10^9/L, Neutrophils >=1.5x10^9/L, Platelets >=100 x10^9/L, Hemoglobin >=5.5
- •mmol/L, Creatinine <=1.5x ULN, AST <= 1.5 x ULN, ALT <= 1.5 x ULN, Bilirubin <=1.5
- •- LDH < 2 x ULN.
- •- Women of childbearing potential (WOCBP) must use highly effective method(s)
- •of contraception during T-VEC and nivolumab treatement and for a period of 5
- •months after the last dose of nivolumab.
- •- Women of childbearing potential must have a negative serum or urine pregnancy
- •test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours
- •prior to en-rollment and within 24 hours prior to the start of Nivolumab.
- •- Men receiving nivolumab and who are sexually active with WOCBP should use
- •contraception during treatment and for a period of 7 months after the last dose
- •of nivolumab.
- •- Men who are sexually active with WOCBP must use any contraceptive method with
- •a failure rate of less than 1% per year.
- •- Women who are not of childbearing potential (i.e., who are postmenopausal),
- •or sur-gically sterile as well as azoospermic men do not require contraception.
- •- Patient is capable of understanding and complying with the protocol
- •requirements and has signed the Informed Consent document.
- •- Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily
- •prednisone equivalent, are permitted in the absence of active autoimmune
- •- International normalization ratio (INR) or prothrombin time (PT) <=1.5 x ULN,
- •unless the subject is receiving anticoagulant therapy, in which case PT and
- •partial thromboplastin time (PTT)/ activated PTT (aPTT) must be within
- •therapeutic range of intended use of anticoagulants.
排除标准
- •- Liver, Bone, Lung, Brain or other Visceral Metastases
- •- No measurable lesion according to RECIST 1.1.
- •- Prior radiotherapy for melanoma.
- •- Prior systemic cancer therapies, including, but not limited to anti-CTLA-4,
- •anti-PD-1, anti-PD-L1.
- •- No other malignancies, except adequately treated and a cancer-related
- •life-expectancy of more than 5 years.
- •- Patients will be excluded if they test positive for hepatitis B virus surface
- •antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody),
- •indicating acute or chronic infection.
- •- Patients will be excluded if they have known history of testing positive for
- •human im-munodeficiency virus (HIV) or known acquired immunodeficiency syndrome
- •- History or evidence of active autoimmune disease that requires systemic
- •treatment (ie, with use of disease modifying agents, corticosteroids or
- •immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or
- •physiologic corticosteroid re-placement therapy for adrenal or pituitary
- •insufficiency, etc.) is not considered a form of systemic treatment. Evidence
- •of clinically significant immunosuppression such as the following:
- •- Primary immunodeficiency state such as Severe Combined Immunodeficiency
- •- Cconcurrent opportunistic infection.
- •- Receiving systemic immunosuppressive therapy (> 2 weeks) including oral
- •steroid doses > 10 mg/day of prednisone or equivalent within 7 days prior to
- •enrollment.
- •- Active herpetic skin lesions or prior complications of HSV-1 infection (e.g.,
- •herpetic keratitis or encephalitis).
- •- Requirement of intermittent or chronic systemic (intravenous or oral)
- •treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent
- •topical use.
- •- Previous treatment with talimogene laherparepvec or any other oncolytic
- •- Received live vaccine within 30 days prior to enrollment.
- •- Subject has known sensitivity to talimogene laherparepvec or nivolumab or any
- •of its components to be administered during dosing.
- •- Female subject of childbearing potential who is unwilling to use highly
- •effective method(s) of effective contraception during study treatment and
- •through 5 months after the last dose of study medication (per protocol through
- •3 months after the last dose of talimogene laherparepvec and through 5 months
- •after the last dose of nivolumab).
- •- Sexually active subjects and their partners unwilling to use male or female
- •latex con-dom to avoid potential viral transmission during sexual contact while
- •on treatment and within 30 days after treatment with talimogene laherparepvec.
- •- Subjects who are unwilling to minimize exposure with his/her blood or other
- •body fluids to individuals who are at higher risks for HSV-1 induced
- •complications such as immunosuppressed individuals, individuals known to have
- •HIV infection, pregnant women, or infants under the age of 3 months, during
- •talimogene laherparepvec treatment and through 30 days after the last dose of
- •talimogene laherparepvec.
- •- No Allergies and Adverse Drug Reaction.
- •- History of allergy to study drug components.
- •- History of severe hypersensitivity reaction to any monoclonal antibody.
- •- No underlying medical conditions that, in the Investigator's opinion, will
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研究者
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