Safety and Efficacy of p53 Gene Therapy Combined With Immune Checkpoint Inhibitors in Solid Tumors.

Exclusion criteria

• . History of allergic reactions to any components of the treatments (Ad-p53 or immune checkpoint inhibitors).
• . Active alcohol dependence
• . Neuropathy of less than or equal to grade 2 CTCAE.
• . Except for ongoing treatment with anti-PD-1 or anti-PD-L1 which is permitted (see Inclusion Criterion #4 above), there should be no other antibody-based therapy, targeted small-molecule therapy, hormonal therapy, chemotherapy, radiation, biological or investigational therapy within 14 days of first administration of Study Treatment (C1D1). Subjects with prior cytotoxic or investigational products less than 2 weeks prior to trial treatment might be eligible after discussion between investigator and Sponsor, if toxicities from the prior treatment have been resolved to Grade 1 (NCI CTCAE). If a patient with HNSCC is receiving combination pembrolizumab plus chemotherapy, the first Ad-p53 Study Treatment should be administered 2 weeks following the completion of final chemotherapy treatments and 5 days before their next anti-PD-1/anti-PD-L1 scheduled dose. Ad-p53 intratumoral injections should not be given within 24 hours of immune checkpoint inhibitor infusions.
• . Prior additional malignancy within 2 years except for non-melanoma skin cancer, carcinoma in situ of the breast, oral cavity, cervix or other cancers, unless approved by the Sponsor.
• . Prior autologous or allogenic organ or tissue transplantation.
• . Severe, active comorbidity, including any of the following:
• . Active clinically serious infection (grade 2 or greater, CTCAE) or requiring intravenous antibiotics at the time of study treatment.