NCT03259425终止2 期
Phase II Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma (Neo-NivoHF10)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Pathological Response
研究概览
简要总结
This is a single-arm, open label, Phase II study evaluating the safety and efficacy of neoadjuvant Nivolumab and HF10 in resectable stage IIIB, IIIC, and IVM1a melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be >18 years or older.
- •Participants must have stage IIIB, IIIC, or IVM1a (equivalent staging at time of enrollment via American Joint Committee on Cancer (AJCC) 7th edition) metastatic melanoma which is eligible for complete surgical resection.
- •Prior systemic, regional and radiation anticancer therapies must have been completed at least three months prior to enrollment. Prior therapies (including anti-programmed death (PD)-1 inhibitors) are allowed provided three months have elapsed from last dose.
- •Participants must be a candidate for intralesional therapy.
- •At least 1 injectable cutaneous, subcutaneous, or nodal melanoma lesion > 10 mm in longest diameter OR
- •Multiple injectable melanoma lesions which in aggregate have a longest diameter of > 10 mm AND
- •Must have no known bleeding diathesis or coagulopathy that would make intratumoral injection unsafe.
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Serum (LDH) level < 1.5 upper limit of normal (ULN) within 28 days prior to enrollment.
- •Participants have adequate organ function within 28 days prior to enrollment, as defined in the protocol
- •Men and women of childbearing potential must agree to use adequate contraception from the time of consent through 7 months after final nivolumab study treatment.
- •Females of childbearing potential must have a negative urine or serum pregnancy test within 1 week prior to the start of treatment.
- •Participants must be able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •Participants with active visceral, central nervous system, or any bone metastases melanoma (Stage IVM1b or IVM1c).
- •Participants whose primary diagnosis was ocular melanoma.
- •Participants receiving anti-herpes medication (i.e., acyclovir, famciclovir, or valacyclovir) within 1 week prior to initiating HF10 treatment. Participants may not require intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug other than intermittent topical use.
- •Participants who have an active herpetic skin lesion(s) or prior complications of herpes simplex virus (HSV)-1 infection.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator.
- •Medical history of autoimmune disease (e.g. Crohn's disease, ulcerative colitis) or other disease requiring systemic glucocorticoid or immunosuppressive therapy. Subjects who receive daily steroid replacement therapy serve as an exception to this rule. Daily prednisone equivalent at doses up to 10 mg would qualify.
- •Participants with clinically evident Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Epstein-Barr Virus (EBV) infection are excluded.
- •Pregnant or breast feeding women; women desiring to become pregnant within the timeframe of the study are also excluded.
研究组 & 干预措施
Nivolumab and HF10, all participants
Experimental
干预措施: Nivolumab (Drug)
Nivolumab and HF10, all participants
Experimental
干预措施: HF10 (Drug)
结局指标
主要结局
Pathological Response
时间窗: at time of surgery (12 weeks)
Following 12 weeks of neoadjuvant treatment with nivolumab and HF10, participants underwent definitive surgery. A percent viable tumor was assessed semi-quantitatively in the definitive surgical resection specimen by estimating the proportion of residual tumor in relation to the total tumor area and reported as percentage viability. A pathologic complete response was defined as no viable residual melanoma cells in the surgical specimen. A major pathologic response was defined as \<50% viable tumor cells. A minor pathologic response was defined as 50% or greater viable tumor cells, including specimens that had 100% viability at surgery.
次要结局
- Recurrence-free Survival: Number of Participants With no Disease Recurrence After Surgery(up to 2 years post-surgery (1 year after end of adjuvant nivolumab, which was given for up to 1 year post-surgery))
- Overall Survival: Number of Participants Alive One Year After Completing Adjuvant Nivolumab(up to 2 years post-surgery (1 year after end of adjuvant nivolumab, which was given for up to 1 year post-surgery))
- Number of Participants With Adverse Events Related to HF10 Treatment(throughout HF10 treatment (up to 84 days))
- Number of Participants With Adverse Events Related to Nivolumab Treatment(throughout nivolumab treatment (up to 84 days prior to surgery and up to 1 year after surgery))
- Number of Participants With Complete Surgical Resection(Within 28 days after Day 84)
- Radiographic Response: Number of Participants Within Each Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Response Category(12 weeks from baseline to surgery)
研究者
研究点 (1)
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