Phase 1 Clinical Trial of a Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease
This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. The hypothesis of the trial is that synthetic long peptide personalized cancer vaccines will be safe and capable of generating measurable neoantigen-specific T-cell responses enabling ctDNA clearance. The personalized cancer vaccines are composed of synthetic long peptides corresponding to prioritized cancer neoantigens and will be co-administered with poly-ICLC.
• 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 duration of study participation, and for 5 months after completion of study interventions. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
• No concurrent investigational therapies outside of this protocol are allowed.
• 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.
• Age ≥ 18 years.
• ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
• Histologically confirmed gastroesophageal adenocarcinoma
• Stage II or III gastroesophageal adenocarcinoma (GEC).
• Complete surgical resection of GEC (R0). Full recovery from surgery and enrollment within 52 weeks following surgery with curative intent. 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:
‣ Esophageal and Esophagogastric junction adenocarcinoma T1 N1-3 M0 or T2-4 N0-2M0.
⁃ Gastric adenocarcinoma T1-2 N1-3 M0 or T3-4 N0-3 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 and 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 duration of study participation, and for 5 months after completion of study interventions. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
• No concurrent investigational therapies outside of this protocol are allowed.
• 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.
• Age ≥ 18 years.
• ECOG performance status ≤ 1.
• Histologically or cytologically confirmed diagnosis of Melanoma. Stage IIB/C or IIIB-C (per AJCC 8th edition). Completed R0 resection within 36 months prior to enrollment and have fully recovered from surgery.
• Planning to receive or have received adjuvant immunotherapy for 1 year.
• Availability of a SignateraTM ctDNA report within 28 days prior to enrollment demonstrating ctDNA-positivity (MRD+). Note: Patients may be pre-screened prior to obtaining ctDNA results to facilitate assay design.
• 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.
• 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
• 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.
• Age ≥ 18 years.
• ECOG performance status ≤ 1.
• Histological diagnosis of non-small cell lung carcinoma, stages II, IIIA or IIIB with complete R0 resection. Completed R0 resection within 9 months of surgery.
• Planned to receive or have received adjuvant immunotherapy for 1 year.
• Availability of a SignateraTM ctDNA report within 28 days prior to enrollment demonstrating ctDNA-positivity (MRD+). Note: Patients may be pre-screened prior to obtaining ctDNA results to facilitate assay design.
• 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.
• 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
• 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.