Primary Objective(s):~- To evaluate the major pathologic response (MPR; ≤ 10% residual tumor) rate of SAR444245 combined with cemiplimab administered in the neoadjuvant setting~Secondary Objective(s):~To evaluate the safety and tolerability of neoadjuvant SAR444245 plus cemiplimab using NCI-CTCAE version 5.0~To evaluate the feasibility of neoadjuvant SAR444245 plus cemiplimab by assessing the percentage of patients not able to undergo the initially proposed~surgery due to disease progression or an adverse event attributed to the drug combination~To evaluate the objective response rate (ORR) to neoadjuvant SAR444245 plus cemiplimab by RECIST 1.1 (12)~To evaluate the proportion of patients who changed TNM stage (ie: change of TNM stage post-treatment as compared to pre-treatment) followed neoadjuvant SAR444245 plus cemiplimab~To assess the 1-year disease-free (DFS) survival rate~Exploratory Objective(s):~To evaluate HPV cell-free DNA as a biomarker of response to therapy~To evaluate pre- and post- treatment tumor and blood biomarkers and correlate with pathologic and clinical response and toxicity.~To evaluate the relationship between matched time-point RECIST criteria on anatomic imaging (T1/T2 MRI or contrast CT) with candidate functional imaging (diffusion-weighted imaging, MR relaxometry, MRI/CT radiomics), pathologic (MPR) and serum (cfDNA) novel biomarkers of therapeutic response.
To learn if SAR444245 given in combination with cemiplimab can help to kill cancer cells in patients with HPV-related oropharynx cancer who are scheduled to have surgery to remove the disease