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

September 11, 2023 updated by: ImmunoVaccine Technologies, Inc. (IMV Inc.)

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: up to 13 months
per RECIST v1.1 criteria
up to 13 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: up to 13 months
per iRECIST criteria
up to 13 months
Duration of Response (DOR)
Time Frame: up to 23 months
up to 23 months
Disease Control Rate (DCR)
Time Frame: up to 13 months
up to 13 months
Time to Progression (TTP)
Time Frame: up to 23 months
up to 23 months
Progression Free Survival (PFS)
Time Frame: up to 23 months
up to 23 months
Progression Free Survival (6m PFS)
Time Frame: at 6 months
at 6 months
Overall Survival (OS)
Time Frame: up to 23 months
up to 23 months
CA-125 Response
Time Frame: up to 13 months
monthly measurements
up to 13 months
Frequency of adverse events
Time Frame: up to 13 months
graded using NCI CTCAE v5.0
up to 13 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cell mediated immune response
Time Frame: up to 13 months
analysis of PBMC/plasma samples
up to 13 months
Changes in Tumor Micro-environment (TME)
Time Frame: up to 2 months
analysis of paired biopsies
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ImmunoVaccine Technologies, Inc. (IMV Inc.)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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