Personalized Cancer Vaccine (PCV) Strategy in Patients with Solid Tumors and Molecular Residual Disease

Eligibility Criteria

• * Age ≥ 18 years.
• * ECOG performance status ≤ 1 (Karnofsky ≥ 60%).
• * Histologically confirmed muscle-invasive bladder cancer (MIBC).
• * Patients with carcinomas showing mixed histologies are required to have a dominant transitional cell pattern.
• * Tumor, nodes, metastases (TNM) classification (based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th ed.) at pathological examination of surgical resection specimen as follows: pT2-4aN0M0 or pT0-4aN+M0. For patients being treated with neoadjuvant chemotherapy who are being considered for inclusion prior to surgery, clinical staging is acceptable.
• * Availability of a ctDNA report that is based on tumor tissue specimen and matched blood within 28 days of enrollment.
• * Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis.
• * Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
• * Receiving any other investigational agents, or planning to receive other investigational agents as part of neoadjuvant therapy.
• * Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
• * A psychiatric illness or social situations that would limit compliance with study requirements as determined by the investigator from the medical history, physical exam, and/or medical record.
• * Prior or currently active autoimmune disease requiring management with immunosuppression. This includes inflammatory bowel disease, ulcerative colitis, Crohn's disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines. In the case of asthma or chronic obstructive pulmonary disease taking inhaled corticosteroids that does not require daily systemic corticosteroids is acceptable. Additionally, local acting steroids (topical, inhaled, or intraarticular) will be allowed. Patients on intermittent or short course steroids will be allow if the dose does not exceed 4 mg of dexamethasone (or equivalent) per day for \> 7 consecutive days. Premedication for chemotherapy does not apply to this criterion and may be administered as per SOC practice. Any patients receiving steroids should be discussed with the PI to determine if eligible.
• * Pregnant and/or breastfeeding.
• * Known HIV-positive status.
• * History of positive test for Hepatitis B virus surface antigen (HBsAg) and/or positive Hepatitis C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.