Merkel Cell Carcinoma Cutaneous Squamous Cell Carcinoma or Other Advanced Solid Tumors: A Phase 1b/2 Study of Cavrotolimod Combined with Pembrolizumab or Cemiplimab (AST-008-102)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Or Other Advanced Solid Tumors
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Must have an advanced inoperable histologically diagnosed solid tumor. 2) Willing to use one of the following effective methods of contraception for at least 30 days before administration of cavrotolimod, during treatment with cavrotolimod, pembrolizumab, or cemiplimab, and for at least four months after the last dose of cavrotolimod, pembrolizumab, or cemiplimab. 3) Adequate organ function. 4) No history of CTCAE G4 irAEs from CPI.

You may not be eligible for this study if the following are true:

  • 1) Small molecule or tyrosine kinase inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of cavrotolimod, chemotherapy or biological cancer therapy within 3 weeks prior to the first dose of cavrotolimod, nitrosourea, or radioisotope within 6 weeks prior to first dose of cavrotolimod, or non-recovery to CTCAE G1 or better from the AEs due to cancer therapeutics administered more than 4 weeks earlier. 2) Known hypersensitivity to any phosphorothioate oligonucleotide, or previous exposure to a TLR9 agonist drug. 3) Previous severe hypersensitivity reaction to treatment with pembrolizumab, cemiplimab or another anti-PD-(L)1 monoclonal antibody.


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