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: Efficacy as measured by objective response rate

Primary Outcome 1 - Timeframe: Approximately 24 months

Primary Outcome 2 - Measure: Safety as measured by the rate of adverse events

Primary Outcome 2 - Timeframe: Approximately 24 months

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:
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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

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Overall Contact

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LOCATION