Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

Part of paid clinical trials in Irvine, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06980038
Phase
PHASE2
Status
Recruiting
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Conditions

  • Head and Neck Squamous Cell Carcinoma
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Nasal Cavity Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Nasal Cavity Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma
  • Stage III Laryngeal Cancer AJCC v8
  • Stage III Lip and Oral Cavity Cancer AJCC v8
  • Stage III Nasopharyngeal Carcinoma AJCC v8
  • Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
  • Stage IVA Laryngeal Cancer AJCC v8
  • Stage IVA Lip and Oral Cavity Cancer AJCC v8
  • Stage IVA Nasopharyngeal Carcinoma AJCC v8
  • Stage IVB Laryngeal Cancer AJCC v8
  • Stage IVB Lip and Oral Cavity Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Anti-CD40 Agonist Monoclonal Antibody CDX-1140 — BIOLOGICAL
    Given IV
  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan
  • Tumor Resection — PROCEDURE
    Undergo resection surgery

Study Details

This phase II trial compares the effectiveness of cemiplimab with CDX-1140 to cemiplimab without CDX-1140 prior to surgery in treating patients with stage III-IV head and neck cancer. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1140 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving cemiplimab with CDX-1140 versus cemiplimab alone before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed for patients with stage III-IV head and neck cancer.

Key Dates

Start date
May 27, 2026
Status verified
May 2026
Primary completion
Nov 24, 2027
Completion
Nov 24, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (Cemiplimab)
    Patients receive cemiplimab IV over 30 minutes on day 1. Patients then undergo standard of care surgical resection on day 29-36 and receive standard of care adjuvant therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET during screening and tumor biopsy and blood sample collection throughout the study.
  • Experimental: Arm II (CDX-1140 and cemiplimab)
    Patients receive CDX-1140 IV over 90 minutes on day 1 and cemiplimab IV over 30 minutes on day 4. Patients then undergo standard of care surgical resection on day 29-36 and receive standard of care adjuvant therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET during screening and tumor biopsy and blood sample collection throughout the study.

Primary Outcome Measure

Incidence of adverse events (AE) [ Time Frame: From the time of their first treatment with CDX-1140 and/or cemiplimab (REGN2810), up to 2 years after surgical resection ]

Locations (6)

FacilityCityStateZIPSite coordinators
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612
Site Public Contact
[email protected]
877-827-8839
Victoria M. Villaflor (PRINCIPAL_INVESTIGATOR)
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Site Public Contact
[email protected]
877-827-8839
Victoria M. Villaflor (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Site Public Contact
888-946-7447
Jose A. Monteiro de Oliveira Novaes (PRINCIPAL_INVESTIGATOR)
Ochsner Medical Center JeffersonNew OrleansLouisiana70121
Site Public Contact
[email protected]
504-842-8084
Daniel Johnson (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232
Site Public Contact
412-647-8073
Kevin J. Contrera (PRINCIPAL_INVESTIGATOR)
VCU Massey Comprehensive Cancer CenterRichmondVirginia23298
Site Public Contact
[email protected]
804-628-6430
Erin R. Alesi (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CAEmory University Hospital Midtown· Atlanta, GAOchsner Medical Center Jefferson· New Orleans, LAUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PAVCU Massey Comprehensive Cancer Center· Richmond, VA

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