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

Key Inclusion Criteria:

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

Key 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