EUCTR2018-002172-40-IT进行中（未招募）1 期
Primary Ipilimumab and Nivolumab combo-immunotherapy followed by adjuvant Nivolumab in locally advanced or limited metastatic melanoma. - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
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
- •Patients must have histologically or cytologically confirmed 8th ed. AJCC Stage IIIB/C/D
- •or Stage IV oligometastatic resectable melanoma. Patients with cutaneous, mucosal, acral,
- •ocular or unknown primary melanomas are eligible for enrollment. Oligometastatic
- •melanoma is defined as three or fewer areas of resectable disease excluding central
- •nervous system and bone involvement. In case of involvement of three areas, one must be
- •superficial (cutaneous-subcutaneous). Resectable tumors are defined as having no
- •significant vascular, neural or bony involvement. A multidisciplinary discussion within
- •surgical oncologists, medical oncologists, and radiologist will assess if disease is
- •resectable.
- •· Signed Written Informed Consent.
- •· Patients must be willing and able to comply with scheduled visits, treatment schedule,
- •laboratory tests and all protocol procedures.
- •· Males and Females, ages =18 years of age.
- •· Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •· Have measurable disease based on RECIST 1.1.
- •· Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor
- •lesion at baseline and at the time points specified in the Study Procedure Tables.
- •· Known BRAF V600 mutation status as determined by local institutional standard. All
- •BRAF statuses (BRAF wild type or BRAF 600 mutation positive) are eligible.
- •· Patients who have been previously treated in the adjuvant setting for melanoma will be
- •eligible for treatment after a 28 day washout period.
- •· Patients must be medically fit enough to undergo surgery as determined by the treating
- •medical and surgical oncology team.
- •· Demonstrate adequate organ function as defined below: Hematologic Absolute neutrophil
- •count (ANC) >/= 1.5 X 10^9/L; Hemoglobin >/= 9.5 g/dL Platelets >/= 100 X 10^9/L
- •PT/INR and PTT >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) AST and
- •ALT Albumin /=2.5 g/dL Renal Creatinine OR Calculated creatinine
- •clearance OR 24-hour urine creatinine clearance /= 50 mL/min >/= 50
- •· Women are eligible to participate if: non-childbearing potential defined as pre-menopausal
- •females with a documented tubal ligation or hysterectomy; or postmenopausal defined as
- •12 months of spontaneous amenorrhea
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •oncological therapies or other concomitant experimental oncologic treatments.
- •B. Major surgery within the previous 3 weeks
- •C. Cerebral, leptomeningee or bone metastases
- •D. Pregnancy or lactation.
- •E. Concomitant pathologies that increase, in the opinion of investigators, the risk associated with
- •the Participation in the study, the administration of the treatment or interfering with the
- •interprettazioen of Results
- •F. Active oncological pathologies arising in the two years preceding enlistment except
- •Pre-existing diagnosis of melanoma and treatable neoplasia and apparently treated with local
- •G. Patients with autoimmune diseases known or suspected, with the exception of vitiligo, diabetes
- •mellitus of type I, hypothyroidism resulting from autoimmune diseases and requiring substitution
- •therapy, Psoriasis that does not require systemic therapy, or conditions that you expect a flare to
- •Cause of external factors
- •H. Corticosteroid therapy (> 10 mg/day of prednisone or equivalent) or other treatment
- •Immunosuppressants within 14 days of administration of treatment
- •I. Topical or inhalatory steroids and replacement therapy for adrenal insufficiency with > 10
- •mg/day of prednisone or equivalents are allowed in the absence of an active autoimmune disease
- •J. Previous anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody therapy.
研究者
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