Nous-PEV: a Novel Immunotherapy for Lung Cancer and Melanoma

Inclusion Criteria

• •1. Age ≥ 18 years.
• •2. Patients with histologically or cytologically confirmed unresectable stage III or stage IV Cutaneous Melanoma, as per AJCC staging system (8th edition). First-line treatment-naive patients.
• •3. Participation in this trial will be dependent upon supplying tumor tissue from newly obtained specimen. Newly obtained biopsies of a tumor lesion, not previously irradiated, must be provided in the form of excisional biopsies, resected tissue or core needle biopsies.
• •4. Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1 by the local site Investigator / radiologist assessment
• •5. Presence of at least one lesion amenable to repeated biopsy, ideally not the one being used for measuring.
• •6. Willingness to undergo a minimum of two fresh lesion biopsies (pre-treatment and on-treatment).
• •7. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• •8. Life expectancy of at least 12 months.
• •9. Adequate renal, hepatic, and hematologic functions
• •10. A female patient is eligible to participate if she is not pregnant and not breastfeeding
• •11. A male patient must agree to use an adequate contraception
• •1. Age ≥ 18 years.
• •2. Histologically or cytologically confirmed stage IV squamous or non-squamous NSCLC without EGFR or ALK/ROS1 /RET genomic alteration.
• •3. Tumor expression with PD-L1 ≥50% tumor proportion score (TPS).
• •4. First-line treatment-naïve patients.
• •5. Participation in this trial will be dependent upon supplying tumor tissue from a newly obtained specimen. Newly obtained biopsies of a tumor lesion, not previously irradiated, must be provided in the form of excisional biopsies, resected tissue or core needle biopsies.
• •6. Presence of at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 as determined by the local site Investigator / radiologist assessment.
• •7. Presence of at least one tumor lesion amenable to repeated biopsy, if possible, ideally not the one being used for measuring.
• •8. Willingness to undergo a minimum of two fresh tumor biopsies (pre-treatment and on-treatment).
• •9. ECOG performance status 0 to 1.
• •10. Life expectancy of at least 6 months.
• •11. Adequate renal, hepatic, and hematologic functions
• •12. A female patient is eligible to participate if she is not pregnant and not breastfeeding
• •13. A male patient must agree to use a contraceptive during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.