Primary Outcomes:

Primary Outcome 1 - Measure: Efficacy as measured by objective response rate

Primary Outcome 1 - Time Frame: Approximately 24 months

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

Primary Outcome 2 - Time Frame: Approximately 24 months

Condition:

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

Eligibility

Criteria:
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

- Subjects with HCC, NSCLC, BlCa, or MSI-H subjects other than those with gastric or
colorectal cancer must have evidence of survivin expression in their pre-treatment
biopsy sample

- 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No