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. 2022 Aug 24;12:935383. doi: 10.3389/fonc.2022.935383
Inclusion criteria
  • 18 years of age or older

  • Histologically or cytologically verified, inoperable locally recurrent or metastatic SCAC

  • No prior systemic therapy other than the following:

  • •Chemotherapy administered concomitantly with radiotherapy as a radiosensitizing agent

  • •Prior neoadjuvant or adjuvant therapy if completed ≥6 months before study entry

  • Measurable disease per RECIST v1.1 as determined by local site investigator/radiology assessment and after any tissue collected during biopsy

  • Adequate tissue and whole blood sample with the central testing result before randomization

  • Biopsy for archival samples within 9 months before randomization

  • ECOG performance status 0 to 1

  • If HIV-positive, then must be stable as defined by:

  • •CD4+ count ≥200/μl

  • •Undetectable viral load per standard of care assay

  • •Receiving antiretroviral therapy (ART/HAART) for at least 4 weeks before study enrollment and have not experienced any HIV-related opportunistic infection for at least 4 weeks before study enrollment