Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC

ID#: NCT03916627

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: July 23, 2019

End Date: August 07, 2027

Contact Information:
Clinical Trials Administrator
Summary: The primary objective of the study is to evaluate the clinical activity of neoadjuvant cemiplimab therapy in patients with resectable Non-small cell lung cancer (NSCLC), Hepatocellular carcinoma (HCC), and Head and neck squamous cell carcinoma (HNSCC) lesions, as measured by pathological evaluations of resected tumors. The secondary objectives of the study are: - To assess the anti-tumor activity of neoadjuvant and adjuvant cemiplimab therapy as defined by multiple criteria - To determine the safety and tolerability of neoadjuvant and adjuvant cemiplimab therapy including delay to surgery - To assess the change in tumor-infiltrating CD8 T-cell density and to explore the correlation to the pathological response to therapy
Eligibility: 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