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8110 Gatehouse Road, Falls Church, VA 22042

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)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04812535

Background Information

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.

Offered At

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

Eligibility Information

  • 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

Ineligibility Information

  • 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