Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

  • days left to enroll
  • participants needed
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 27 January 2021


The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.

Condition Advanced Cutaneous Squamous Cell Carcinoma
Treatment IBI318
Clinical Study IdentifierNCT04611321
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on27 January 2021


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Inclusion Criteria

Able to understand and willing to sign the ICF
Adults 18 years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy at least 12 weeks
Adequate organ and bone marrow function
Histologically confirmed diagnosis of invasive CSCC

Exclusion Criteria

Prior treatment with an agent that blocks the PD-1/PD-L1 pathway
Any investigational drugs received within 4 weeks prior to the first study treatment
Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy
History of autoimmune disease , present active autoimmune disease or inflammatory diseases
Pregnant or nursing females
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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