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

Prior treatment

• 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
• 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
• Allogenic tissue/solid organ transplant
• Ongoing treatment with steroid therapy or other immunosuppressive
• Receipt of live attenuated vaccines

Other illness

• Malignant bowel obstruction or recent history of bowel obstruction
• 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
• 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
• Acute or chronic skin and/or microvascular disorders
• Severe hypersensitivity (≥ Grade 3) to pembrolizumab

Lab values

• For NSCLC subjects: Known EGFR mutations or ALK rearrangements

Other

• Clinical ascites or pleural fluid that cannot be managed
• For OvCa, subjects with any single lesion greater than 5 cm
• Active CNS metastases and/or carcinomatous meningitis
• Edema or lymphedema in the lower limbs \> grade 2

• Subjects with advanced or metastatic solid tumours who have completed treatment with first line therapy:
  • Epithelial ovarian, fallopian tube, or peritoneal cancer
  • Hepatocellular carcinoma
  • Non-small cell lung cancer
  • Urothelial cancer
  • Microsatellite instability high solid tumours, other than the above indications
• Radiologic and/or biochemical evidence of disease progression
• Completion of pre-treatment tumour biopsy
• Must have measurable disease by RECIST v1.1
• Ambulatory with an ECOG 0-1
• Life expectancy ≥ 6 months
• Meet protocol-specified laboratory requirements