Clinical trial NCT03332576: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epithelial Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Keywords: vaccine
immunotherapy
combination therapy
Lead sponsor: ImmunoVaccine Technologies, Inc. (IMV Inc.)
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety as measured by adverse event reporting (CTCAE)
timeFrame: up to 11 months
Secondary outcomes:
measure: Cell mediated immunity as measured by the antigen specific response in peripheral blood
timeFrame: up to 11 months
measure: Impact on residual tumour
timeFrame: up to 11 months
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References: