Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects with Platinum-Resistant, Epithelial Ovarian Cancer (AVALON) - AVALO

Immunovaccine Technologies Inc. (IMV Inc.)0 个研究点目标入组 73 人开始时间: 2023年1月30日最近更新: 2023年8月21日

适应症

试验速览

暂无简介。

•Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, histologically diagnosed high-grade serous
•Platinum-resistant disease, meeting one of the following definitions.
•a. Relapsing within 3-6 months after completion of initial platinum-based
•treatment, OR
•b. Progressing while on treatment with = 2nd platinum-based therapy,
•c. Progressing within 6 months after the completion of = 2nd platinum-based treatment
•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.
•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 36
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 37

•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 cancer 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 dysfunction
•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

发起方

Immunovaccine Technologies Inc. (IMV Inc.)