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About
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
Full description
Primary Objective(s):
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.
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Inclusion criteria
neutrophils <1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL, total bilirubin >1.5 upper limit of normal (ULN) (except known Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 of upper limit of normality (ULN) Glomerular Filtration Rate (GFR) <40 mL/min/1.73 m2 (GFR will be calculated using the CKD-EPI equation per institutional standard)
or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
Exclusion criteria
History of previous malignancy other than malignancy treated with curative intent and with no evidence of active disease ≥3 years before the first dose of the study drugs and of low potential risk for recurrence. Patients with the following diagnoses represents an exception and may enroll:
International Normalized Ratio (INR) or Prothrombin Time (PT) or Activated Partial Thromboplastin Time (aPTT) >1.5 × ULN unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
Participants under anti-hypertensive treatment who cannot temporarily (for at least 36 hours) withhold antihypertensive medications prior to each IMP dosing.
Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤14 days prior to administration of investigational product. Patients with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study provided the viral load is undetectable at Screening.
Unstable or severe uncontrolled medical condition (e.g., unstable cardiac or pulmonary function or uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk to the patient associated with his or her participation in the study.
Female subjects who are pregnant or breast-feeding
Known hypersensitivity (≥ Grade 3) to or contraindication for the use of any study intervention or components thereof, including premedication to be administered in this study, as well as PEG or any pegylated drug and E. coli-derived protein".
Patient with active, known, or suspected autoimmune disease that has required systemic therapy. Exceptions: patients with vitiligo, type I diabetes mellitus, and endocrinopathies.
Primary purpose
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0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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