Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors

Exclusion Criteria

• •Chemotherapy or immunotherapy within treatment within 28 days of start of study treatment
• •Radiotherapy within treatment within 2 weeks of start of study treatment
• •Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor where subject was discontinued from that treatment due to a Grade 3 or higher immune-related toxicity
• •For NSCLC subjects: Known EGFR mutations or ALK rearrangements
• •Prior receipt of survivin-based vaccine(s) and/or immunotherapies
• •Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
• •Clinical ascites or pleural fluid that cannot be managed
• •Malignant bowel obstruction or recent history of bowel obstruction
• •For OvCa, subjects with any single lesion greater than 5 cm
• •Autoimmune disease requiring treatment within the last two years (except replacement therapy)
• •Recent history of thyroiditis
• •Any history of (non-infectious) pneumonitis that required steroid therapy or current pneumonitis
• •Presence of a serious acute or chronic infection
• •Active CNS metastases and/or carcinomatous meningitis
• •GI condition that might limit absorption of oral agents
• •Allogenic tissue/solid organ transplant
• •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 live attenuated vaccines
• •Acute or chronic skin and/or microvascular disorders
• •Edema or lymphedema in the lower limbs \> grade 2
• •Severe hypersensitivity (≥ Grade 3) to pembrolizumab