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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

• Ovarian Cancer
• Hepatocellular Carcinoma
• Non-small Cell Lung Cancer
• Bladder Cancer
• Microsatellite Instability-High

ELIGIBILITY

Key Inclusion Criteria:
* Subjects with advanced or metastatic solid tumours who have completed treatment with first line therapy:
1. Epithelial ovarian, fallopian tube, or peritoneal cancer

- 2. Hepatocellular carcinoma

- 3. Non-small cell lung cancer

- 4. Urothelial cancer

- 5. 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

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LOCATION