Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients

Exclusion Criteria

• •ii. Non-microsatellite instability high (non-MSI high).
• •iii. Progression on previous systemic therapy.
• •3. At least one tumor lesion amenable to IT injection and biopsy that has not been previously irradiated.
• •4. Measurable disease based on RECIST 1.1., including ≥ 1 measurable lesion(s) to be injected
• •5. Performance status of 0 or 1 on the ECOG Performance Scale
• •6. Life expectancy of \>3 months.
• •7. Willingness to provide biological samples required for the duration of the study, including a fresh tumor biopsy sample whilst on study.
• •8. Adequate organ function assessed by laboratory values obtained ≤14 days prior to enrollment
• •Exclusion:
• •1. Availability of and patient acceptance of an alternative curative therapeutic option.
• •2. Patients with tumor lesion(s) \> 5cm in diameter.
• •3. Recent or ongoing serious infection, including any active Grade 3 or higher per the NCI CTCAE, v5.0 viral, bacterial, or fungal infection within 2 weeks of registration.
• •4. Patients who have a diagnosis of ocular, mucosal or acral melanoma.
• •5. Known seropositivity for and with active infection with HIV.
• •6. Seropositive for and with evidence of active viral infection with HBV.
• •7. Seropositive for and with active viral infection with HCV.
• •8. Known history of active or latent TB.
• •9. Any concomitant serious health condition, which, in the opinion of the investigator, would place the patient at undue risk from the study, including uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
• •10. Prior therapy within the following timeframe before the planned start of study treatment as follows:
• •1. Small molecule inhibitors, and/or other investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
• •2. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤ 3 weeks or 5 half-lives, whichever is shorter.
• •3. Radioimmunoconjugates or other similar experimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter.
• •11. NYHA classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or SVT).
• •12. Any known or suspected active organ-threatening autoimmune disease, such as inflammatory bowel disease, autoimmune hepatitis, lupus, or pneumonitis, with the exception of hypothyroidism and type 1 diabetes that are controlled with treatment
• •13. Immunodeficiency or immunosuppression, including systemic corticosteroids at \>10 mg/day prednisone or equivalent within 1 week prior to planned start of study treatment.
• •14. History of Grade 3 or 4 immune-mediated adverse reaction to immune CPIs.
• •15. Toxicities from previous therapies that have not resolved to a Grade 1 or less.
• •16. History of non-infectious pneumonitis that required steroids, or current pneumonitis.
• •17. High volume disease, as assessed clinically by the medical monitor via parameters such as radiologic impression and tumor markers or lactate dehydrogenase (LDH).
• •18. Portal vein thrombosis involving more than intrahepatic portal vein branches: thrombosis of the right or left portal vein branch or the bifurcation, partial or complete obstruction of the portal vein trunk.
• •18.19. Known concurrent malignancy.