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 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