START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer

Exclusion Criteria

• •1. Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1.
• •2. Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of \>10 mg/day prednisone) within 4 weeks before Day 1. Inhaled or topical corticosteroid use is allowed.
• •3. Prior or concomitant radiotherapy within 4 weeks before Day 1.
• •4. Participation in a study with an investigational drug or device within 4 weeks prior to Day 1.
• •5. Active bacterial, viral, or fungal infection that requires systemic therapy.
• •6. Active autoimmune disease that has required systemic treatment in the past two years.
• •7. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study.
• •8. Any concomitant medical condition requiring receipt of a therapeutic anticoagulant that, in the opinion of the treating physician, cannot safely be withheld to allow for repeated injection of PeptiCRAd 1 and tumor biopsies.
• •9. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C or active tuberculosis.
• •10. Known active central nervous system metastases. Patients with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage are excluded.
• •Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted.
• •11. Any prior severe AE according to Common Terminology Criteria for Adverse Events (CTCAE), severe hypersensitivity reaction attributed to prior anti-PD1 or PDL1 therapy or components of the study intervention or has a history of any contraindication that, in the investigator's opinion, would contraindicate pembrolizumab administration such as:
• •* Resolution of side effect of prior anti-PD1 or PDL1 therapy to Grade 1
• •* Grade 2 or higher pneumonitis
• •* Grade 4 AST or ALT elevation
• •* Grade 3 or higher colitis attributable to immunotherapy Note: in the absence of clinical symptoms of pancreatitis, elevations of amylase or lipase are not contraindications to therapy on this trial.
• •12. History of or planned tissue / organ transplant.
• •13. Females who are pregnant or breast feeding or expecting to conceive within the projected duration of the study starting with the screening visit or males expecting to father children within the projected duration of the study starting with the screening visit.
• •14. Unwillingness or inability to comply with the study protocol for any reason.
• •15. Admission to an institution by virtue of an order issued by the judicial or administrative authorities.
• •16. Sponsor or Contract Research Organization employees, or employees under the direct supervision of the investigator or the investigational sites and/or involved directly in the study.
• •17. Prior or concurrent malignancy, unless the natural history or treatment of the disease does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.