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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

ConditionsHead and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaNasal Cavity Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaOropharyngeal Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Nasal Cavity Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaStage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Nasopharyngeal Carcinoma AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8Stage IVA Nasopharyngeal Carcinoma AJCC v8Stage IVB Laryngeal Cancer AJCC v8Stage IVB Lip and Oral Cavity Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have histologically or cytologically confirmed American Joint Committee on Cancer (AJCC) stage III-IV T0-4, N0-3b, M0 mucosal head and neck squamous cell carcinoma (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx, and nasal cavity) that is appropriate for surgical resection. Both previously untreated (primary) and recurrent (salvage) settings will be eligible. Tumors must be accessible to biopsy in clinic (patients with laryngeal, hypopharyngeal, nasal cavity and base of tongue tumors will have endoscopic biopsies)

For patients with oropharyngeal cancer, only p16-negative (non-human papillomavirus [HPV] related) patients will be eligible

Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam

Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of cemiplimab (REGN2810) alone or in combination with CDX-1140 in patients < 18 years of age, children are excluded from this study

Disqualifiers

Active or documented history of autoimmune disease within 2 years before screening

Prior or planned allogeneic hematopoietic stem cell transplantation (HSCT)

History of organ transplant that requires use of immunosuppressive medications

Current or prior use of immunosuppressive medication within 14 days prior to the start of study drug administration. Immunosuppressants may interfere with study drug efficacy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anti-CD40 Agonist Monoclonal Antibody CDX-1140

    Biological/Vaccine

    Given IV

  • Biopsy Procedure

    Procedure/Surgery

    Undergo tumor biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Cemiplimab

    Biological/Vaccine

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Tumor Resection

    Procedure/Surgery

    Undergo resection surgery

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Arm I (Cemiplimab)Active comparator 5 interventions
Group B: Arm II (CDX-1140 and cemiplimab)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AE)

Will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Descriptive statistics will be used.

Time frame
From the time of their first treatment with CDX-1140 and/or cemiplimab (REGN2810), up to 2 years after surgical resection
2

Major pathologic response

Defined as ≤ 10% of viable tumor area relative to total tumor area.

Time frame
Up to 2 years after surgical resection

Secondary outcomes

1

Acute incidence of adverse events

Will be assessed using NCI CTCAE version 5.0. Descriptive statistics will be used.

Time frame
From the time of their first treatment with CDX-1140 and/or cemiplimab (REGN2810), up to 2 years after surgical resection
2

Late incidence of adverse events

Will be assessed using NCI CTCAE version 5.0. Descriptive statistics will be used.

Time frame
From the time of their first treatment with CDX-1140 and/or cemiplimab (REGN2810), up to 2 years after surgical resection
3

Quantitative pathologic response

Two-sample t-test, Mann-Whitney U test, or log rank test will be used where appropriate to analyze the correlation between efficacy outcomes.

Time frame
Up to 2 years after surgical resection
4

Tumor infiltrating immune populations

Two-sample t-test, Mann-Whitney U test, or log rank test will be used where appropriate to analyze the correlation between efficacy outcomes.

Time frame
Up to 2 years after surgical resection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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