Table 1

Selected cemiplimab combination trials in advanced solid tumors*

ICIs ‡‡Other agentsNCT trial numberPhasePredictive biomarkersStatus
Cemiplimab in combination with other immunotherapy agents
CemiplimabSAR-439459 (anti-TGF¶-beta mAb)NCT04729725IbSomatic mutations
Change in protein expression
Change in RNA expression
Circulating- free DNA
Peripheral mononuclear blood cells
Cytokine levels
TGF-beta
Microbiome analysis		Recruiting
CemiplimabPan-TGF¶-beta neutralizing abSAR439459NCT03192345INot availableRecruiting
CemiplimabCMP-001 (CpGA DNA Toll-like receptor 9 agonist)NCT04916002IINot availableNot yet recruiting
CemiplimabREGN7075 (bispecific antibody directed against both EGFR†§ and the costimulatory T-cell-specific surface glycoprotein CD28)NCT04626635I and IINot availableRecruiting
Cemiplimab or pembrolizumabCavrotolimod (Toll-like receptor 9 agonist)NCT03684785I and IITumor-infiltrating lymphocytes, PD-L1, and other checkpoint expressionRecruiting
CemiplimabREGN3767 (anti-LAG3† mAb)†NCT03005782INot availableRecruiting
CemiplimabSAR441000 (mRNA mixture encoding IL-12** sc, interferon alpha 2b, GM-CSF††, and IL-15 sushi)NCT03871348INot availableRecruiting
Cemiplimab in combination with chemotherapy
CemiplimabImmunotherapy
Chemotherapy		NCT04988074IIRate of induction tumor/HPV
HPV ctDNA clearance
Characterization of immune microenvironment		Not yet recruiting
Cemiplimab or other ICIsCP-506 (HAPs)‡
Carboplatin		NCT04954599I
II		Not availableNot yet recruiting
Not yet recruiting

  • *As of November 8, 2021. Source: clinicaltrials.gov.

  • †Lymphocyte-activation gene 3.

  • ‡Hypoxia-activated prodrugs.

  • §Human epidermal growth factor receptor.

  • ¶ transforming growth factor

  • ** Interleukin

  • ††granulocyte-macrophage colony-stimulating factor

  • ‡‡ Immune checkpoint inhibitors

  • HPV, human papilloma virus; mAb, monoclonal antibody; PD-L1, programmed death-ligand 1.