Clinical Trial Details

Primary Objective:
1.1 Primary Objectives
1.1.1

• To evaluate major pathologic response rate (defined as ?10% of residual viable tumor) of CDX-1140 combined with cemiplimab (REGN2810) compared with cemiplimab (REGN2810) alone.

Secondary Objectives:
1.2 Secondary Objectives
1.2.1
Evaluate the rate of any pathologic response of CDX-1140 in combination with cemiplimab (REGN2810).
1.2.2

• To evaluate toxicity and tolerability of CDX-1140 and programmed cell death protein 1 (PD-1) blockade combination in neoadjuvant (pre-surgical) setting.
  1.2.3

• To compare gene expression profiles by RNA sequencing (RNAseq) between CDX-1140 and control groups as well as correlate gene expression with pathologic response.
  1.2.4

• To evaluate circulating tumor DNA (ctCNA) as a biomarker of response to neoadjuvant immunotherapy
  1.2.5
  To evaluate the pharmacokinetics (PK) of CDX-1140 and cemiplimab (REGN2810) used in combination (Arm 2) and the relationship of outcomes to baseline and time-varying clearance of both agents.

Exploratory Objectives:
1.3 Exploratory Objectives
1.3.1

• To evaluate dynamic changes in tumor microenvironment (TME) and circulating immune cell populations. To compare dynamic changes in TME while on treatment with subsequent pathologic response in the final specimen.
  1.3.2

• To evaluate changes in circulating plasma cytokines pre and post neoadjuvant immunotherapy with CDX-1140 and cemiplimab (REGN2810).
  1.3.3

• To correlate major pathologic response with the level of programmed cell death ligand 1 (PD-L1) expression.
  1.3.4
  To explore the correlation of pathologic response to disease free recurrence and overall survival at 2 years after surgery.