Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer
Inclusion Criteria
- Histologically confirmed, stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
- Platinum-resistant or -sensitive subjects after completing first-line treatment (debulking surgery and adjuvant or neoadjuvant treatment with standard of care treatment such as carboplatin and paclitaxel). Subjects may have had any number of subsequent lines of chemotherapy.
- Must have evidence of progressive disease with either biochemical (i.e. rising CA-125) and/or radiologic progression
- Must have measurable disease by RECIST v1.1, a successful pre-treatment tumor biopsy, and be willing to undergo tumor biopsy during treatment
- Ambulatory with an ECOG 0-1
- Life expectancy ≥ 6 months
- Meet protocol-specified laboratory requirements
Exclusion Criteria
- Eligible for otherwise curative treatment or undergoing concurrent therapy
- Prior receipt of survivin based vaccines or immune checkpoint inhibitors (e.g. anti-CTLA-4, anti-PD-1, anti-PD-L1, or any other antibody or drug specifically targeting T cell co-stimulation) or an IDO inhibitor
- Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
- Clinical ascites
- Any single lesion greater than or equal to 4 cm (per RECIST v1.1)
- Malignant bowel obstruction
- History of autoimmune disease requiring treatment within the last two years (except vitiligo or diabetes)
- Recent history of thyroiditis
- Presence of a serious acute infection or chronic infection
- Active central nervous system (CNS) or leptomeningeal metastasis (brain metastases)
- GI condition that might limit absorption of oral agents
- Other serious intercurrent chronic or acute illness, including myocardial infarction or cerebrovascular event within 6 months
- Ongoing treatment with steroid therapy or other immunosuppressive
- Receipt of monoamine oxidase inhibitors (MAOIs) or UGT1A9 inhibitors
- Receipt of live attenuated vaccines
- Acute or chronic skin and/or microvascular disorders
- Edema or lymphedema in the lower limbs > grade 2
California
Palo Alto
Oregon
Portland
Pennsylvania
Philadelphia
The Phase 1b component is a multicenter, non-randomized, open label, uncontrolled, safety and effectiveness study to identify the recommended Phase 2 dose (R2PD) of epacadostat in combination with DPX-Survivac and cyclophosphamide. The Phase 2 component was initially a multicenter, randomized, open-label study to evaluate the safety and effectiveness of DPX-Survivac + cyclophosphamide with or without the RP2D of epacadostat. The design of the study has been amended to a single arm study in which up to 16 evaluable subjects will be enrolled to received DPX-Survivac plus intermittent low dose cyclophosphamide (i.e. treatment arm 2).
Trial Phase Phase I/II
Trial Type Treatment
Lead Organization
ImmunoVaccine Technologies, Inc. (IMV Inc.)
- Primary ID ONC-DPX-Survivac-06
- Secondary IDs NCI-2017-00256, DeCidE1
- Clinicaltrials.gov ID NCT02785250