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

Fallopian Tube Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332576
• Other study ID #: ONC-DPX-Survivac-03
• Status: Completed
• Phase: Phase 1
• Start date: August 23, 2013
• Est. completion date: September 9, 2019

Study information

• Verified date: June 2021
• Source: ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 9, 2019
• Est. primary completion date: September 8, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Peritoneal Cancer
• Peritoneal Neoplasms

Intervention

Biological:
• DPX-Survivac
SubQ injection
• DPX-Survivac(Aqueous)
SubQ injection

Drug:
• Cyclophosphamide
PO BID

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
United States	Winthrop University Hospital	Mineola	New York
United States	Lenox Hill Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
ImmunoVaccine Technologies, Inc. (IMV Inc.)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by adverse event reporting (CTCAE)		up to 11 months
Secondary	Cell mediated immunity as measured by the antigen specific response in peripheral blood		up to 11 months
Secondary	Impact on residual tumour	Evaluated by standard of care radiology and CA-125	up to 11 months