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

Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer.

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.

Study Overview

• Status: Terminated
• Conditions: Platinum-resistant Epithelial Ovarian Cancer
• Intervention / Treatment: Other: Maveropepimut-S; Drug: Cyclophosphamide 50mg

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).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 0A9
      • CHUM - Centre Hospitalier de l'Universite de Montreal
• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • PanOncology Trials
• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford Health Care
  • Florida
    • Ocala, Florida, United States, 34474
      • Ocala Oncology
  • New York
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital-Long Island
    • New York, New York, United States, 10016
      • NYU Langone: Laura and Isaac Perlmutter Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Maveropepimut-S; SC injection on days 7, 28, then q8w; Other Names: MVP-S; DPX-Survivac; Drug: Cyclophosphamide 50mg; PO BID, one week on, one week off; Other Names: Cytoxan; Procytox; CPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	per RECIST v1.1 criteria	up to 13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	per iRECIST criteria	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
Progression Free Survival (6m PFS)		at 6 months
Overall Survival (OS)		up to 23 months
CA-125 Response	monthly measurements	up to 13 months
Frequency of adverse events	graded using NCI CTCAE v5.0	up to 13 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cell mediated immune response	analysis of PBMC/plasma samples	up to 13 months
Changes in Tumor Micro-environment (TME)	analysis of paired biopsies	up to 2 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Actual): July 24, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Immunotherapy; T cell education; DPX-Survivac; Platinum-resistant (PROC); High grade serous (HGSOC)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide
• Other Study ID Numbers: P1606-SUR-O25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No