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

NCT05243524 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: P1606-SUR-O25
• Study Type: interventional
• Target: 16
• Locations: 3 countries
• Sites: 6

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.

Conditions

Platinum-resistant Epithelial Ovarian Cancer

Keywords

T cell education; DPX-Survivac; Immunotherapy; Platinum-resistant (PROC); High grade serous (HGSOC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  per RECIST v1.1 criteria

  up to 13 months

Secondary Outcomes (9)

• 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

Other Outcomes (2)

• Cell mediated immune response

  up to 13 months

• Changes in Tumor Micro-environment (TME)

  up to 2 months

Study Arms (1)

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.

Other: Maveropepimut-S; Drug: Cyclophosphamide 50mg

Interventions

Maveropepimut-S OTHER

SC injection on days 7, 28, then q8w

Also known as: MVP-S, DPX-Survivac

MVP-S + CPA

Cyclophosphamide 50mg DRUG

PO BID, one week on, one week off

Also known as: CPA, Procytox, Cytoxan

MVP-S + CPA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmunoVaccine Technologies, Inc. (IMV Inc.): lead

Study Sites (6)

Stanford Health Care

Palo Alto, California, 94305, United States

Location

Ocala Oncology

Ocala, Florida, 34474, United States

Location

NYU Langone Hospital-Long Island

Mineola, New York, 11501, United States

Location

NYU Langone: Laura and Isaac Perlmutter Cancer Center

New York, New York, 10016, United States

Location

CHUM - Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

PanOncology Trials

San Juan, 00935, Puerto Rico

Location

MeSH Terms

Interventions

Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 17, 2022
• Study Start: August 5, 2022
• Primary Completion: July 24, 2023
• Study Completion: August 31, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (4); PR (1)