Phase 1 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer

April 20, 2017 updated by: ImmunoVaccine Technologies, Inc. (IMV Inc.)

Phase 1-2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer

Immunotherapy is a novel way to treat cancer and does so by targeting the immune system to destroy tumor cells. Many different therapeutic vaccines have been evaluated in phase 1, 2, and even phase 3 trials. Much has been learned about the principles of applying immune-based therapies and specifically the types of patients that may be most likely to mount an effective immune response. When used alone, cancer vaccines may have their greatest impact earlier in the disease course or in situations with minimal residual disease.

ImmunoVaccine Technologies Inc. (Immunovaccine) is an immuno-oncology company developing a novel adjuvanting technology platform termed DepoVax. DepoVax was created to enhance the speed, strength and duration of an immune response. The peptide antigens included in DPX-Survivac are designed to target Survivin, a protein which is over-expressed in many cancer types, including epithelial ovarian cancers.

This study was designed be a phase 1-2 trial to determine the safety and immunogenicity profiles of DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose oral cyclophosphamide. The dosing-finding phase 1 study of 15 subjects would move directly into a randomized phase 2 study. However, with the evolving field of immunotherapy Immunovaccine has begun to focus on combination therapies, combining DPX-Survivac treatment with checkpoint inhibitors and other immune modulators, such as in NCT02785250.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The standard treatment for all ovarian cancer is aggressive debulking surgery followed by chemotherapy. Ovarian carcinoma is one of the most chemosensitive solid tumors and early stage patients are most responsive to treatment. However, despite improvements to the standard treatment over the past three decades, almost all patients with advanced stage disease at presentation will relapse, with an average progression free survival of 16-18 months. When residual or recurrent disease manifests itself, resistance to chemotherapy often prohibits further curative therapy. Therefore, there are still significant unmet needs in treating ovarian cancer patients.

Treatment with DPX-Survivac is for patients with late-stage ovarian, fallopian tube, or peritoneal cancer who have completed initial chemotherapy treatment and successful debulking surgery. The phase 1 dose finding study will administer 3 doses of DPX-Survivac with or without accompanying low dose oral cyclophosphamide.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

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
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • United States
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research 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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Main Inclusion Criteria:

  • Subjects with stage IIc-IV epithelial ovarian, fallopian tube and peritoneal cancer who have completed adjuvant treatment consisting of up to 8 cycles of paclitaxel and carboplatin chemotherapy or other acceptable chemotherapy after initial debulking surgery with evidence of a complete or partial response by radiological imaging. These subjects may remain on hormonal therapy during the trial if such treatment has been prescribed by their treating physician. These subjects may have been in a clinical trial for an investigational carboplatin based adjuvant therapy.
  • Subjects with recurrent ovarian, fallopian tube or peritoneal cancer who have clinical or radiologic evidence of a complete or partial response or stable disease after completion of first-line chemotherapy for their recurrent disease and are not suitable for additional cytotoxic therapy are eligible. These subjects may have previously received a course of adjuvant chemotherapy earlier in their disease management as described in point one above. These subjects are eligible regardless of their CA-125 results. These subjects may have been in a clinical trial of an investigational therapy.
  • Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy greater than 60 days prior to receiving the first injection of DPX-Survivac
  • At least 30 days since localized surgery, radiotherapy or chemotherapy
  • Subjects may be on a biphosphonate provided it had not been initiated within 14 days prior to receiving the first injection of DPX-Survivac

Main Exclusion Criteria:

  • Subjects undergoing concurrent chemotherapy, radiation therapy, immunotherapy are excluded
  • Subjects who participated in therapeutic adjuvant ovarian cancer studies are excluded except for platinum-based adjuvant studies
  • Subjects who have received more than one course of chemotherapy for recurrent disease
  • Subjects receiving bevacizumab for maintenance therapy are excluded (subjects who received bevacizumab as part of their adjuvant therapy will be permitted)
  • History of autoimmune disease
  • Subjects with recent history of thyroiditis
  • Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection including but not limited to: urinary tract infection, HIV, viral hepatitis
  • Subjects with brain metastases
  • Concurrent (within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
  • Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions
  • Serious intercurrent chronic or acute illness, such as cardiac disease, hepatic disease, or other illness considered by the investigator as an unwarranted high risk for an investigational product
  • Subjects on steroid therapy or other immunosuppressive, such as azathioprine or cyclosporin A
  • Allergies to any component of the vaccine
  • Pregnant or nursing mothers
  • Subjects with a medical or psychological impediment to probable compliance with the protocol

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vaccine
Cohort A: 0.5 mL of DPX-Survivac (injection)
Biological: DPX-Survivac
Vaccine targeting survivin antigen will be administered subcutaneously.
EXPERIMENTAL: Vaccine + low dose cyclophosphamide
Cohort B: 0.1 mL DPX-Survivac (injection) with low dose cyclophosphamide (oral)
Biological: DPX-Survivac
Vaccine targeting survivin antigen will be administered subcutaneously.
Drug: low dose cyclophosphamide (oral)
Low dose cyclophosphamide will be taken by mouth.
EXPERIMENTAL: Vaccine + low dose cyclophosphamide.
Cohort C: 0.5 mL DPX-Survivac (injection) with low dose cyclophosphamide (oral)
Biological: DPX-Survivac
Vaccine targeting survivin antigen will be administered subcutaneously.
Drug: low dose cyclophosphamide (oral)
Low dose cyclophosphamide will be taken by mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of reported adverse events
Time Frame: Until 6 month follow up
The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of subcutaneous administration of DPX-Survivac.
Until 6 month follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Levels of cell mediated immunity targeting the survivin epitopes
Time Frame: Until 6 month follow up
Until 6 month follow up

Collaborators and Investigators

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

Sponsor

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2011

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (ESTIMATE)

August 12, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC-DPX-Survivac-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Ovarian Cancer

Clinical Trials on DPX-Survivac

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe