NCT05535023

Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx Squamous Cell Carcinoma

Phase 2 Study of Neoadjuvant SAR444245 Plus Cemiplimab in HPV Related Oropharynx

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma
• Oropharynx Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	SAR444245	Given by vein (IV)
DRUG	Cemiplimab	Given by vein (IV)

Timeline

• Start date: 2022-08-24
• Primary completion: 2023-07-25
• Completion: 2023-07-25
• First posted: 2022-09-10
• Last updated: 2023-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study