Study of DPX-Survivac Therapy in Patients With Recurrent Ovarian Cancer

Key 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

Key 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