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

• Status: Completed
• Trial end date: 2019-09-09
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoVaccine Technologies, Inc.; ImmunoVaccine Technologies, Inc. (IMV Inc.)
• Treatments: Cyclophosphamide; Vaccines

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