Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients
Non-small Cell Lung Cancer, Hepatocellular Carcinoma, Head and Neck Squamous Cell Carcinoma
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, HCC, HNSCC, Resectable
Eligibility Criteria
Key Inclusion Criteria:
- Patient must have a known diagnosis of NSCLC, HCC, or HNSCC as defined in the protocol
- Patient must be willing and able to provide blood samples at the indicated time points
- Patient must be willing and able to have excisional or core needle biopsies of tumor prior to initiation of cemiplimab as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patient is determined to be a surgical candidate for resection of their tumor
- Adequate organ and bone marrow function as defined in the protocol
Key Exclusion Criteria:
- Patients who have had any systemic anti-cancer therapy or radiotherapy within 6 months prior to entering the study for their current tumor or a different primary tumor
- Patients whose tumor burden, or pace of tumor growth, in the opinion of the Investigator will not permit delaying surgery
- Patients who have participated in a study of an investigational agent or an investigational device within 4 weeks of study therapy or 5 half-lives (whichever is longer)
- Patients who have had major surgery within 14 days prior to initiation of neoadjuvant Therapy
- Patients with metastatic disease for whom the intent of surgery would not be curative
- Uncontrolled, intercurrent illness as defined in the protocol and as determined by the Investigator
- Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
- Has active autoimmune disease that has required systemic treatment in the past 1 year
- Has a known, additional malignancy that is progressing and/or requires active treatment. Exceptions include patients with: basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy; in situ cervical or anal cancer; prostate cancer on stable dose of hormonal therapy without rising PSA; breast cancer who have been treated with curative intent, who may be on hormonal therapy.
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to study treatment.
- Uncontrolled infection with human immunodeficiency virus (HIV), HBV or hepatitis C infection (HCV); or diagnosis of immunodeficiency as defined in the protocol
- NSCLC cohorts only: Patients do not have a history of smoking. History of smoking is defined as smoking ≥100 cigarettes in a lifetime.
- NSCLC cohorts only: Patients with tumors tested positive for EGFR gene mutations, ALK gene translocations, or ROS1 fusions.
Note: Other protocol defined Inclusion/Exclusion criteria apply
Sites / Locations
- Icahn School of Medicine at Mount SinaiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort A1
Cohort A2
Cohort A3
Cohort B
Cohort C
Cohort B2
Cohort B3
Cemiplimab prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
Cemiplimab and platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
Platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
Cemiplimab prior to surgery; cemiplimab post surgery (HCC)
Cemiplimab prior to surgery; standard of care radiation and/or chemotherapy followed by cemiplimab post surgery (HNSCC) Not open for accrual
SBRT 8 Gy X 3 fractions followed by cemiplimab prior to surgery; cemiplimab post surgery (HCC)
Cemiplimab and fianlimab before and after surgery (HCC)