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OpenTrials
Completed

NCT Number: NCT03332576

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DPX-Survivac

Biological

SubQ injection

DPX-Survivac(Aqueous)

Biological

SubQ injection

Cyclophosphamide

Drug

PO BID

Primary outcomes

  1. Safety as measured by adverse event reporting (CTCAE)

    Time frame: up to 11 months

Secondary outcomes

  1. Cell mediated immunity as measured by the antigen specific response in peripheral blood

    Time frame: up to 11 months

  2. Impact on residual tumour

    Time frame: up to 11 months

    Evaluated by standard of care radiology and CA-125

Sponsors and collaborators

Lead sponsor

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2016
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.