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

NCT ID: NCT05243524

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2023-08-31

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).

Conditions

Platinum-resistant Epithelial Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MVP-S + CPA

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.

Group Type: EXPERIMENTAL

Maveropepimut-S

Intervention Type: OTHER

SC injection on days 7, 28, then q8w

Cyclophosphamide 50mg

Intervention Type: DRUG

PO BID, one week on, one week off

Interventions

Maveropepimut-S

SC injection on days 7, 28, then q8w

Intervention Type: OTHER

Cyclophosphamide 50mg

PO BID, one week on, one week off

Intervention Type: DRUG

Other Intervention Names

MVP-S; DPX-Survivac; CPA; Procytox; Cytoxan

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ImmunoVaccine Technologies, Inc. (IMV Inc.)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford Health Care

Palo Alto, California, United States

Ocala Oncology

Ocala, Florida, United States

NYU Langone Hospital-Long Island

Mineola, New York, United States

NYU Langone: Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

CHUM - Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

PanOncology Trials

San Juan, , Puerto Rico

Countries

United States; Canada; Puerto Rico

Other Identifiers

P1606-SUR-O25

Identifier Type: -

Identifier Source: org_study_id