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

Inclusion Criteria Cohort #1: * Age ≥ 18 years. * ECOG performance status ≤ 2 (Karnofsky ≥ 60%). * Histologically confirmed muscle-invasive bladder cancer (MIBC) or upper tract urothelial carcinoma (renal pelvis and/or ureter). * Patients with carcinomas showing mixed histologies are required to have a dominant transitional cell pattern. * Complete surgical resection of MIBC (R0) or upper tract urothelial carcinoma (renal pelvis and/or ureter). 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. * Patient must have fully recovered from surgical resection in the opinion of the treating MD. * ctDNA positive result as identified by Signatera. * Radiologic confirmation (by conventional imaging) of absence of residual disease and absence of metastasis. * Adequate bone marrow and organ function as defined below: * WBC ≥ 1.5 K/cumm * Absolute neutrophil count ≥ 1.0 K/cumm * Platelets ≥ 50 K/cumm * Hemoglobin ≥ 8.0 g/dL * Total bilirubin ≤ 1.5 x IULN * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN * Creatinine clearance \> 30 mL/min by Cockcroft-Gault * The effects of synthetic long peptide personalized cancer vaccines and Hiltonol on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the durati…