Study on DPX-Survivac with Low Dose Cyclophosphamide and Pembrolizumab for Advanced and Recurrent Solid Tumors

Inclusion Criteria

• Have advanced or metastatic solid tumors and have completed first-line therapy, including:
  • Epithelial ovarian, fallopian tube, or peritoneal cancer
  • Liver cancer (hepatocellular carcinoma)
  • Non-small cell lung cancer
  • Bladder cancer (urothelial cancer)
  • Other high microsatellite instability solid tumors
• Show signs of disease progression through scans or tests
• Have completed a tumor biopsy before treatment
• Have measurable disease according to specific criteria
• Be able to walk and perform daily activities with minimal assistance (ECOG score 0-1)
• Have a life expectancy of at least 6 months
• Meet specific lab test requirements

Exclusion Criteria

• Have received chemotherapy or immunotherapy within 28 days before starting the study treatment
• Have had radiation therapy within 2 weeks before starting the study treatment
• Have previously been treated with certain immune therapies and experienced severe side effects
• For lung cancer patients: Have specific genetic mutations (EGFR or ALK)
• Have received survivin-based vaccines or immunotherapies before
• Have another active cancer, except for certain skin, cervical, or bladder cancers
• Have fluid buildup in the abdomen or chest that cannot be managed
• Have a bowel obstruction or recent history of it
• For ovarian cancer patients: Have any single tumor larger than 5 cm
• Have an autoimmune disease requiring treatment in the last two years
• Have a recent history of thyroid inflammation
• Have a history of lung inflammation requiring steroids or current lung inflammation
• Have a serious infection
• Have active cancer spread to the brain or spinal fluid
• Have a digestive condition affecting absorption of oral medications
• Have had a tissue or organ transplant
• Have a serious illness, including recent heart attack or stroke
• Are currently on steroid therapy or other immune-suppressing treatments
• Have received live vaccines recently
• Have severe skin or blood vessel disorders
• Have significant swelling in the lower limbs
• Have a severe allergy to pembrolizumab