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

Part of paid clinical trials in New York, New York.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03916627
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cemiplimab — DRUG
    Administered intravenous (IV)
  • Platinum Doublet — DRUG
    Administered intravenous (IV)
  • fianlimab — DRUG
    Administered IV

Study Details

This study is being done to better understand whether or not cemiplimab by itself and in combination with other treatments given prior to surgery will cause your tumor to respond in a beneficial way; whether the drug(s) are safe and what side effects they cause; and other details about how they function in the body. One of the treatments that will be combined cemiplimab is another experimental drug called fianlimab. In this form, cemiplimab and fianlimab will each individually be called "study drug" or "study drugs" when combined. Cemiplimab (also known as REGN2810) and fianlimab (also known as REGN3767) are both a type of drug called a monoclonal antibody. Antibodies are proteins naturally found in your blood that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target specific proteins in the body that may be involved in your cancer. * Cemiplimab is a drug that blocks the programmed death receptor 1 (PD-1), a cell receptor on immune cells * Fianlimab is a drug that blocks the action of a protein called lymphocyte activation gene (LAG)-33 (LAG-3)

Key Dates

Start date
Jul 23, 2019
Status verified
Jan 2026
Primary completion
Mar 31, 2025
Completion
May 14, 2030

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1
    Cemiplimab prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
  • Experimental: Cohort A2
    Cemiplimab and platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
  • Experimental: Cohort A3
    Platinum doublet prior to surgery; cemiplimab and platinum doublet post surgery (NSCLC) Not open for accrual
  • Experimental: Cohort B
    Cemiplimab prior to surgery; cemiplimab post surgery (HCC)
  • Experimental: Cohort C
    Cemiplimab prior to surgery; standard of care radiation and/or chemotherapy followed by cemiplimab post surgery (HNSCC) Not open for accrual
  • Experimental: Cohort B2
    SBRT 8 Gy X 3 fractions followed by cemiplimab prior to surgery; cemiplimab post surgery (HCC)
  • Experimental: Cohort B3
    Cemiplimab and fianlimab before and after surgery (HCC)

Primary Outcome Measure

Major pathologic response (MPR) at time of surgery for the NSCLC cohorts [ Time Frame: At time of surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

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By condition
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By specialty
OncologyENTGI oncologyHepatologyLung oncologyLung disease
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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