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

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ClinicalTrials.gov Identifier: NCT03916627
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief 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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Hepatocellular Carcinoma Head and Neck Squamous Cell Carcinoma Drug: cemiplimab Drug: Platinum Doublet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Cohorts B and C are not randomized
Primary Purpose: Treatment
Official Title: A Multi-Cohort Exploratory Study of Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC
Estimated Study Start Date : May 28, 2019
Estimated Primary Completion Date : May 3, 2022
Estimated Study Completion Date : June 11, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A1
Cemiplimab prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC)
Drug: cemiplimab
Administered intravenous (IV)
Other Names:
  • REGN2810
  • Libtayo

Drug: Platinum Doublet
Administered intravenous (IV)

Experimental: Cohort A2
Cemiplimab and platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC)
Drug: cemiplimab
Administered intravenous (IV)
Other Names:
  • REGN2810
  • Libtayo

Drug: Platinum Doublet
Administered intravenous (IV)

Experimental: Cohort A3
Platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC)
Drug: cemiplimab
Administered intravenous (IV)
Other Names:
  • REGN2810
  • Libtayo

Drug: Platinum Doublet
Administered intravenous (IV)

Experimental: Cohort B
Cemiplimab prior to surgery; cemiplimab post surgery (HCC)
Drug: cemiplimab
Administered intravenous (IV)
Other Names:
  • REGN2810
  • Libtayo

Experimental: Cohort C
Cemiplimab prior to surgery; standard of care radiation and/or chemotherapy followed by cemiplimab post surgery (HNSCC)
Drug: cemiplimab
Administered intravenous (IV)
Other Names:
  • REGN2810
  • Libtayo




Primary Outcome Measures :
  1. Major pathologic response (MPR) at time of surgery for the NSCLC cohorts [ Time Frame: At time of surgery ]
    Cohorts A1, A2, A3

  2. Significant tumor necrosis (STN) at time of surgery is the primary endpoint for the HCC cohort [ Time Frame: At time of surgery ]
    Cohort B

  3. Major treatment effect (MTE) at time of surgery is the primary endpoint for the HNSCC cohort [ Time Frame: At time of surgery ]
    Cohort C


Secondary Outcome Measures :
  1. Delay to surgery [ Time Frame: Surgery >28 days following last dose of cemiplimab ]
    As defined by surgery >28 days following last dose of cemiplimab in neoadjuvant period

  2. Disease-free survival (DFS) [ Time Frame: Up to 60 months ]
    Defined as the time from date of surgery until recurrence of tumor or death from any cause

  3. Overall response rate (ORR) [ Time Frame: At time of surgery ]
    Defined as the percent of patients with a complete response (CR) or partial response (PR) documented by the Investigator per modified RECIST 1.1.

  4. Overall survival (OS) [ Time Frame: Up to 60 months ]
    Defined as the time from the first dosing of cemiplimab (chemotherapy for Cohort A3) and date of death for any reason

  5. OS rate [ Time Frame: 12 months ]
  6. OS rate [ Time Frame: 18 months ]
  7. OS rate [ Time Frame: 24 months ]
  8. OS rate [ Time Frame: 36 months ]
  9. OS rate [ Time Frame: 48 months ]
  10. OS rate [ Time Frame: 60 months ]
  11. Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: 90 days post last dose of cemiplimab ]
    Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)

  12. Incidence of irAEs [ Time Frame: 90 days post last dose of cemiplimab ]
    Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)

  13. Incidence of SAEs [ Time Frame: 90 days post last dose of cemiplimab ]
    Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)

  14. Incidence of deaths [ Time Frame: 90 days post last dose of cemiplimab ]
  15. Incidence of laboratory abnormalities [ Time Frame: 90 days post last dose of cemiplimab ]
    Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)

  16. Change in tumor-infiltrating CD8 T-cell density [ Time Frame: Baseline to time of surgery ]
    Defined as the change from baseline to the time of surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Note: Other protocol defined Inclusion/Exclusion criteria apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916627


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Not yet recruiting
New York, New York, United States, 10029
Contact    212-824-9472      
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03916627     History of Changes
Other Study ID Numbers: R2810-ONC-1866
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://errs.regeneron.com/external

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Regeneron Pharmaceuticals:
NSCLC
HCC
HNSCC
Resectable

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Neoplasms, Squamous Cell
Liver Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Hepatocellular
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Bronchogenic
Respiratory Tract Diseases
Adenocarcinoma
Digestive System Diseases
Liver Diseases