Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Treatments: Cyclophosphamide

Criteria

Key Inclusion Criteria:

• 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

• ECOG 0-1

• Live expectancy ≥ 6 months

• Meet protocol-specified laboratory requirements

Key Exclusion Criteria:

• 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