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

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ClinicalTrials.gov Identifier: NCT05243524
Recruitment Status : Recruiting
First Posted : February 17, 2022
Last Update Posted : December 23, 2022
Sponsor:
Information provided by (Responsible Party):
ImmunoVaccine Technologies, Inc. (IMV Inc.)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Platinum-resistant Epithelial Ovarian Cancer Other: Maveropepimut-S Drug: Cyclophosphamide 50mg Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2b Single Arm Study of Maveropepimut-S and Low-Dose Cyclophosphamide in Subjects With Platinum-Resistant, Epithelial Ovarian Cancer.
Actual Study Start Date : August 5, 2022
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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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:
  • CPA
  • Procytox
  • Cytoxan


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 13 months ]
    per RECIST v1.1 criteria


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 13 months ]
    per iRECIST criteria

  2. Duration of Response (DOR) [ Time Frame: up to 23 months ]
  3. Disease Control Rate (DCR) [ Time Frame: up to 13 months ]
  4. Time to Progression (TTP) [ Time Frame: up to 23 months ]
  5. Progression Free Survival (PFS) [ Time Frame: up to 23 months ]
  6. Progression Free Survival (6m PFS) [ Time Frame: at 6 months ]
  7. Overall Survival (OS) [ Time Frame: up to 23 months ]
  8. CA-125 Response [ Time Frame: up to 13 months ]
    monthly measurements

  9. Frequency of adverse events [ Time Frame: up to 13 months ]
    graded using NCI CTCAE v5.0


Other Outcome Measures:
  1. Cell mediated immune response [ Time Frame: up to 13 months ]
    analysis of PBMC/plasma samples

  2. Changes in Tumor Micro-environment (TME) [ Time Frame: up to 2 months ]
    analysis of paired biopsies


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05243524


Locations
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United States, California
Stanford Health Care Recruiting
Palo Alto, California, United States, 94305
Contact: Alaina Poe    650-724-3308    agpoe@stanford.edu   
Principal Investigator: Oliver Dorigo, MD PhD         
United States, Florida
Ocala Oncology Recruiting
Ocala, Florida, United States, 34474
Contact: Vippin Shetty    352-547-1954    vippin.shetty@usoncology.com   
Principal Investigator: Ketan Doshi, MD         
United States, New York
NYU Langone Hospital-Long Island Recruiting
Mineola, New York, United States, 11501
Contact: Kathryn Devlin, RN    516-663-1871    kathryn.devlin@nyulangone.org   
Principal Investigator: Eva Chalas, MD         
NYU Langone: Laura and Isaac Perlmutter Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Kathryn Devlin, RN    516-663-1871    kathryn.devlin@nyulangone.org   
Canada, Quebec
CHUM - Centre hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 0A9
Contact: Genevieve St-Onge    514-890-8000 ext 30777    genevieve.st-onge.recherche.chum@ssss.gouv.qc.ca   
Principal Investigator: Diane Provencher, MD         
Puerto Rico
PanOncology Trials Recruiting
San Juan, Puerto Rico, 00935
Contact: Josselyn Molina-Avila, MD    787-407-3333    josselyn.molina@panoncologytrials.com   
Contact: Isamar Alicea    787-407-3333    isamar.alicea@panoncologytrials.com   
Principal Investigator: Josselyn Molina-Avila, MD         
Sponsors and Collaborators
ImmunoVaccine Technologies, Inc. (IMV Inc.)
More Information
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Responsible Party: ImmunoVaccine Technologies, Inc. (IMV Inc.)
ClinicalTrials.gov Identifier: NCT05243524    
Other Study ID Numbers: P1606-SUR-O25
First Posted: February 17, 2022    Key Record Dates
Last Update Posted: December 23, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ImmunoVaccine Technologies, Inc. (IMV Inc.):
T cell education
DPX-Survivac
Immunotherapy
Platinum-resistant (PROC)
High grade serous (HGSOC)
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists