Spots Global Cancer Trial Database for Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma

Study Description

Brief Summary: 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

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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