Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.

Exclusion Criteria

• •Patients with limited cSCC, who do not require systemic therapy
• •Has known active central nervous system metastases and/or carcinomatous meningitis.
• •Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for ≥4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for ≥14 days prior to first dose of study treatment.
• •Has a diagnosis of immunodeficiency or autoimmune disease, or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 3 weeks prior the first dose of study treatment
• •Patients who have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis
• •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen 4, OX 40, CD137) and was discontinued from that treatment due to a ≥Grade 3 irAE
• •Has severe hypersensitivity (≥Grade 3) to pembrolizumab or IFX-1 and/or any of their excipients or had a severe (≥Grade 3) infusion-related reaction to treatments with other mAbs
• •Patients who fulfil inclusion criterion 6 (washout times) but who have not recovered from side effects of such therapies
• •Has received a live vaccine within 30 days prior to the first dose of study treatment
• •Patients who have undergone major surgery \<4 weeks prior to starting study treatment
• •Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
• •Patients with known ≥Grade 3 (per National Cancer Institute common terminology criteria for adverse events \[NCI CTCAE\] v5.0 criteria) active systemic or cutaneous viral, bacterial, or fungal infection
• •Patients with known history of Hepatitis B or C infections or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C Antibody or RNA. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
• •Patients who have a history of human immunodeficiency virus infection
• •Patients who have a history of interstitial lung disease
• •Patients who have had an allogeneic tissue/solid organ transplant
• •Patients with a history of other malignancies during the past 5 years.
• •Patients who are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 3 months after the last dose of IFX-1 or 120 days after the last dose of pembrolizumab
• •Women of childbearing potential (WOCBP) who have a positive serum pregnancy test result within 7 days before treatment
• •Male patients and WOCBP who do not agree to practice an effective method of contraception during study and until 3 months after last dose of IFX-1 or 120 days after last dose of pembrolizumab
• •Patients with congestive heart failure, Class III or IV, by New York Heart Association criteria
• •Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment
• •Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document