An Open label, Multicenter Phase II study of the C5A-ANTIBODY IFX-1 alone or IFX-1 + PEMBROLIZUMAB in Patients with Pd-1 or Pd-L1-Resistant/Refractory Locally Advanced Or Metastatic Cutaneous Squamous Cell Carcinoma (InFla RX IFX1-P2.8)

The purpose of this study is to determine the safety, effectiveness, and best dosage of the study drug IFX-1 when used alone or in combination with pembrolizumab to treat locally advanced or metastatic Cutaneous Squamous Cell Carcinoma (cSCC). The study will also assess what happens with IFX-1 in the body.

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031
A Department of Inova Fairfax Hospital

• Age 18 years or older
• Patients with biopsy-proven, histologically or cytologically confirmed
  • (a.) locally advanced cSCC not amenable for curative treatment or
  • (b.) metastatic cSCC
• Patients must have been treated with all approved therapies for
  • (a.) inoperable locally advanced cSCC contraindicated for radiation therapy or
  • (b.) metastatic cSCC
• All patients to be included must have progressed on PD-1- or PD-L1-inhibitory antibody therapy
• Patients must have progressed on treatment with an anti-PD1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies
• Additional eligibility in protocol

• Pregnant females, breastfeeding females
• 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.
• 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
• 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 adverse event
• Additional ineligibility in protocol

For additional information, please see: https://www.clinicaltrials.gov/ct2/show/ NCT04812535