Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer
- Conditions
- Platinum-resistant Epithelial Ovarian Cancer
- Interventions
- Other: Maveropepimut-S
- Registration Number
- NCT05243524
- Lead Sponsor
- ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Brief 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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MVP-S + CPA Maveropepimut-S 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. MVP-S + CPA Cyclophosphamide 50mg 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.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) up to 13 months per RECIST v1.1 criteria
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) up to 13 months per iRECIST criteria
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 monthly measurements
Frequency of adverse events up to 13 months graded using NCI CTCAE v5.0
Trial Locations
- Locations (6)
NYU Langone Hospital-Long Island
🇺🇸Mineola, New York, United States
Ocala Oncology
🇺🇸Ocala, Florida, United States
CHUM - Centre hospitalier de l'Université de Montréal
🇨🇦Montréal, Quebec, Canada
PanOncology Trials
🇵🇷San Juan, Puerto Rico
Stanford Health Care
🇺🇸Palo Alto, California, United States
NYU Langone: Laura and Isaac Perlmutter Cancer Center
🇺🇸New York, New York, United States