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

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
DPX-Survivac
DPX-Survivac(Aqueous)
Cyclophosphamide
Sponsored by
ImmunoVaccine Technologies, Inc. (IMV Inc.)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring vaccine, immunotherapy, combination therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Winthrop University Hospital
  • Lenox Hill Hospital
  • Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Safety as measured by adverse event reporting (CTCAE)

Secondary Outcome Measures

Cell mediated immunity as measured by the antigen specific response in peripheral blood
Impact on residual tumour
Evaluated by standard of care radiology and CA-125

Full Information

First Posted
November 2, 2017
Last Updated
June 16, 2021
Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)
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1. Study Identification

Unique Protocol Identification Number
NCT03332576
Brief Title
Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 23, 2013 (Actual)
Primary Completion Date
September 8, 2016 (Actual)
Study Completion Date
September 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImmunoVaccine Technologies, Inc. (IMV Inc.)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Keywords
vaccine, immunotherapy, combination therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
3 Doses DPX-Survivac (1 prime, 2 boost q8w) Low dose cyclophosphamide
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w) Low dose cyclophosphamide
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w) Low dose cyclophosphamide
Intervention Type
Biological
Intervention Name(s)
DPX-Survivac
Intervention Description
SubQ injection
Intervention Type
Biological
Intervention Name(s)
DPX-Survivac(Aqueous)
Intervention Description
SubQ injection
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
PO BID
Primary Outcome Measure Information:
Title
Safety as measured by adverse event reporting (CTCAE)
Time Frame
up to 11 months
Secondary Outcome Measure Information:
Title
Cell mediated immunity as measured by the antigen specific response in peripheral blood
Time Frame
up to 11 months
Title
Impact on residual tumour
Description
Evaluated by standard of care radiology and CA-125
Time Frame
up to 11 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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