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

June 16, 2021 updated by: ImmunoVaccine Technologies, Inc. (IMV Inc.)

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

As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

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
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • United States
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New York, New York, United States, 10028
        • Lenox Hill Hospital

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

Key Inclusion Criteria:

  • Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
  • Complete or partial response following standard of care surgery and first line chemotherapy
  • May have one disease recurrence with complete or partial response or stable disease following standard of care second line care treatment
  • Previous investigational biologic therapy allowed, must be more than 56 days prior to first injection
  • Previous treatment with bisphosphonate allowed, must be completed 14 days prior to first injection
  • Ambulatory with an ECOG 0-1
  • Life expectancy > 6 months
  • Meet protocol-specified lab requirements
  • Provide informed consent and have ability to comply with protocol requirements

Key Exclusion Criteria:

  • Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout periods as specified in protocol)
  • Prior receipt of survivin based vaccines
  • Participation in prior therapeutic adjuvant ovarian cancer studies, except for platinum-based adjuvant studies
  • Progressive disease (rising CA-125 acceptable)
  • More than one course of chemotherapy for recurrent disease
  • Concurrent bevacizumab as maintenance therapy
  • Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
  • History of autoimmune disease
  • Recent history of thyroiditis
  • Presence of a serious acute infection or chronic infection
  • Brain metastases
  • Other serious intercurrent chronic or acute illness
  • Ongoing treatment with steroid therapy or other immunosuppressive
  • Acute or chronic skin 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: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1

6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w)

Low dose cyclophosphamide
Drug: Cyclophosphamide
PO BID
Biological: DPX-Survivac
SubQ injection
Experimental: Cohort 2

6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w)

Low dose cyclophosphamide
Drug: Cyclophosphamide
PO BID
Biological: DPX-Survivac
SubQ injection
Experimental: Cohort 3

3 Doses DPX-Survivac (1 prime, 2 boost q8w)

Low dose cyclophosphamide
Drug: Cyclophosphamide
PO BID
Biological: DPX-Survivac
SubQ injection
Experimental: Cohort 4

5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w)

Low dose cyclophosphamide
Drug: Cyclophosphamide
PO BID
Biological: DPX-Survivac
SubQ injection
Experimental: Cohort 5

5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w)

Low dose cyclophosphamide
Drug: Cyclophosphamide
PO BID
Biological: DPX-Survivac
SubQ injection
Biological: DPX-Survivac(Aqueous)
SubQ injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety as measured by adverse event reporting (CTCAE)
Time Frame: up to 11 months
up to 11 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cell mediated immunity as measured by the antigen specific response in peripheral blood
Time Frame: up to 11 months
up to 11 months
Impact on residual tumour
Time Frame: up to 11 months
Evaluated by standard of care radiology and CA-125
up to 11 months

Collaborators and Investigators

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

Sponsor

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)

August 23, 2013

Primary Completion (Actual)

September 8, 2016

Study Completion (Actual)

September 9, 2019

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC-DPX-Survivac-03

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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