NCT05243524终止2 期
Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer.
ImmunoVaccine Technologies, Inc. (IMV Inc.)6 个研究点 分布在 3 个国家目标入组 16 人开始时间: 2022年8月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
Phase 2, single arm, study to assess the efficacy and safety of maveropepimut-S (MVP-S) and low-dose cyclophosphamide (CPA) in subjects with recurrent, platinum resistant ovarian cancer.
详细描述
A Simon two-stage statistical design to assess MVP-S in combination with low dose CPA in platinum-resistant epithelial ovarian cancer patients who have received no greater than 4 previous lines of anti-cancer therapy.
MVP-S, previously called DPX-Survivac, was recently evaluated in a small Phase 2 single arm study of ovarian cancer patients known as DeCidE1 (NCT02785250).
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, histologically diagnosed high-grade serous
- •Platinum-resistant disease (relapsing within 3-6 months after completion of initial platinum-based treatment). Patients progressing at any time on or after ≥ 2nd platinum-based therapy are eligible.
- •Received ≤ 4 prior lines of anti-cancer therapy for ovarian cancer, including at least one platinum-based therapy
- •Evidence of progressive disease
- •Measurable disease (RECIST v1.1) with at least one non-target lesion accessible by image-guided biopsy. No single lesion may be larger than 4 cm in diameter.
- •Completed pre-treatment tumor biopsy and willing to undergo on-treatment tumor biopsy
- •Live expectancy ≥ 6 months
- •Meet protocol-specified laboratory requirements
排除标准
- •Concurrent chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or radiotherapy
- •Prior receipt of survivin-based vaccines/therapy, immune checkpoint inhibitors, IDO inhibitor, or cell-based therapy
- •Non-epithelial tumor origin of the ovary, fallopian tube, or peritoneum
- •Clinical ascites
- •Concurrent second malignancy other than basal or squamous cell skin cancer, cervical carcinoma in situ, or Stage I or II caner in complete remission
- •GI condition that might limit absorption of oral agents
- •Recent history of thyroiditis
- •History of autoimmune disease requiring treatment within the last two years (except paraneoplastic syndrome, vitiligo, or diabetes)
- •History of bowel obstruction related to the disease
- •Presence of a serious acute infection or chronic infection
- •Uncontrolled concurrent illness or history of significant cardiac or pulmonary disfunction
- •Myocardial infarction or cerebrovascular event within past 6 months
- •Known central nervous system (CNS) or leptomeningeal metastasis (brain metastases)
- •Clinically significant illness or major surgery within past 28 days or anticipated need for major surgery during study treatment
- •Ongoing treatment with steroid therapy or other immunosuppressive
- •Receipt of live attenuated vaccines
- •Edema or lymphedema in the lower limbs > grade 2
- •Acute or chronic skin and/or microvascular disorders
研究组 & 干预措施
MVP-S + CPA
Experimental
All subjects will receive two doses of maveropepimut-S (q3w) followed by up to six doses (q8w) plus low-dose cyclophosphamide on a repeating cycle of one week on/one week off.
干预措施: Maveropepimut-S (Other)
MVP-S + CPA
Experimental
All subjects will receive two doses of maveropepimut-S (q3w) followed by up to six doses (q8w) plus low-dose cyclophosphamide on a repeating cycle of one week on/one week off.
干预措施: Cyclophosphamide 50mg (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 13 months
per RECIST v1.1 criteria
次要结局
- Objective Response Rate (ORR)(up to 13 months)
- Duration of Response (DOR)(up to 23 months)
- Disease Control Rate (DCR)(up to 13 months)
- Time to Progression (TTP)(up to 23 months)
- Progression Free Survival (PFS)(up to 23 months)
- Progression Free Survival (6m PFS)(at 6 months)
- Overall Survival (OS)(up to 23 months)
- CA-125 Response(up to 13 months)
- Frequency of adverse events(up to 13 months)
研究者
研究点 (6)
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