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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03332576
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
ImmunoVaccine Technologies, Inc. (IMV Inc.)

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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Biological: DPX-Survivac Biological: DPX-Survivac(Aqueous) Drug: Cyclophosphamide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : August 23, 2013
Actual Primary Completion Date : September 8, 2016
Actual Study Completion Date : September 9, 2019


Arm Intervention/treatment
Experimental: Cohort 1

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

Low dose cyclophosphamide

Biological: DPX-Survivac
SubQ injection

Drug: Cyclophosphamide
PO BID

Experimental: Cohort 2

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

Low dose cyclophosphamide

Biological: DPX-Survivac
SubQ injection

Drug: Cyclophosphamide
PO BID

Experimental: Cohort 3

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

Low dose cyclophosphamide

Biological: DPX-Survivac
SubQ injection

Drug: Cyclophosphamide
PO BID

Experimental: Cohort 4

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

Low dose cyclophosphamide

Biological: DPX-Survivac
SubQ injection

Drug: Cyclophosphamide
PO BID

Experimental: Cohort 5

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

Low dose cyclophosphamide

Biological: DPX-Survivac
SubQ injection

Biological: DPX-Survivac(Aqueous)
SubQ injection

Drug: Cyclophosphamide
PO BID




Primary Outcome Measures :
  1. Safety as measured by adverse event reporting (CTCAE) [ Time Frame: up to 11 months ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332576


Locations
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United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Lenox Hill Hospital
New York, New York, United States, 10028
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
ImmunoVaccine Technologies, Inc. (IMV Inc.)
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Responsible Party: ImmunoVaccine Technologies, Inc. (IMV Inc.)
ClinicalTrials.gov Identifier: NCT03332576    
Other Study ID Numbers: ONC-DPX-Survivac-03
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ImmunoVaccine Technologies, Inc. (IMV Inc.):
vaccine
immunotherapy
combination therapy
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Peritoneal Neoplasms
Carcinoma, Ovarian Epithelial
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents