ClinicalTrials.gg
RecruitingNCT06980038Updated Oct 26, 2026

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

A Phase 2 interventional study of Anti-CD40 Agonist Monoclonal Antibody CDX-1140 and Biopsy Procedure in Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma and Laryngeal Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI). Recruiting at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Sep 25, 20261 site addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

PRIMARY OBJECTIVE:

I. To evaluate major pathologic response rate (defined as ≤ 10% of residual viable tumor) of anti-CD40 agonist monoclonal antibody CDX-1140 (CDX-1140) combined with cemiplimab (REGN2810) compared with cemiplimab (REGN2810) alone.

SECONDARY OBJECTIVES:

I. Evaluate the rate of any pathologic response of CDX-1140 in combination with cemiplimab (REGN2810).

II. To evaluate toxicity and tolerability of CDX-1140 and programmed cell death protein 1 (PD-1) blockade combination in neoadjuvant (pre-surgical) setting.

III. To compare gene expression profiles by ribonucleic acid (RNA) sequencing (RNAseq) between CDX-1140 and control groups as well as correlate gene expression with pathologic response.

IV. To evaluate circulating tumor deoxyribonucleic acid (DNA) (ctCNA) as a biomarker of response to neoadjuvant immunotherapy V. To evaluate the pharmacokinetics (PK) of CDX-1140 and cemiplimab (REGN2810) used in combination (arm 2) and the relationship of outcomes to baseline and time-varying clearance of both agents.

EXPLORATORY OBJECTIVES:

I. To evaluate dynamic changes in tumor microenvironment (TME) and circulating immune cell populations.

Ia. To compare dynamic changes in TME while on treatment with subsequent pathologic response in the final specimen.

II. To evaluate changes in circulating plasma cytokines pre and post neoadjuvant immunotherapy with CDX-1140 and cemiplimab (REGN2810).

III. To correlate major pathologic response with the level of programmed cell death ligand 1 (PD-L1) expression.

IV. To explore the correlation of pathologic response to disease free recurrence and overall survival at 2 years after surgery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive cemiplimab intravenously (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 computed tomography (CT) scan, positron emission tomography (PET) during screening and tumor biopsy and blood sample collection throughout the study.

ARM II: 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.

After completion of study treatment, patients are followed up at week 9-10, week 18, at 6 months and every 3-6 months for 2 years after surgery.

02

Conditions studied

  • 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
03

In context

Squamous Cell Carcinoma of Head and Neck

2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.

This study's planned enrollment of 44 is close to the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have 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 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 , 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
  • (ECOG) performance status ≤ 2 ( ≥ 60%)
  • (Hb) ≥ 7 g/dL (transfusion allowed to bring Hb to this level)
  • ≥ 1,000/mcL
  • ≥ 100,000/mcL
  • Total ≤ 1.5 × institutional (ULN)
  • (AST) (serum glutamic oxaloacetic transaminase [SGOT]) /alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN
  • Creatinine ≤ 1.5 × institutional ULN OR (GFR) ≥ 60 mL/min/1.73 m\^2
  • (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the Functional Classification. To be eligible for this trial, patients should be class II or better
  • Based on its mechanism of action, cemiplimab (REGN2810) can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the /PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Women of and men should use effective during treatment with cemiplimab (REGN2810) and for 4 months after the last dose. The reproductive and developmental toxicity of CDX-1140 has not been evaluated. Women of childbearing potential and their partners who receive CDX-1140 must therefore take adequate contraceptive measures
  • Ability to understand and the willingness to sign a written document. Legally authorized representatives may sign and give informed consent on behalf of study participants

Exclusion criteria

Exclusion Criteria:

  • Active or documented history of disease within 2 years before screening
  • Prior or planned hematopoietic stem cell transplantation (HSCT)
  • History of organ transplant that requires use of 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
  • Any previous treatment with a or PD-L1 inhibitor, including cemiplimab (REGN2810). It is unclear how prior exposure to immunotherapy would impact future use of checkpoint inhibitors
  • Concurrent use of prednisone (10 mg or more)
  • Patients with new pulmonary infiltrates indicative of pneumonitis, history of (non-infectious) pneumonitis/interstitial lung disease, or current pneumonitis/interstitial lung disease, including grade 1 pneumonitis (i.e., asymptomatic, clinical or diagnostic observation only, intervention not indicated)
  • Another active for which the natural history or treatment has potential to interfere with the safety or efficacy assessment of the regimen on this trial
  • Patients who have not recovered from AE due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
  • Patients who are receiving any other investigational agents, such as concurrent chemotherapy, biologic, immunologic or hormonal therapy for cancer treatment
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDX-1140 or cemiplimab (REGN2810)
  • Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
  • Pregnant women are excluded from this study because of the increased risk of immune-mediated rejection of the developing fetus with cemiplimab (REGN2810). Because of the potential for serious adverse reactions in breastfed children, women should not breastfeed during treatment with cemiplimab (REGN2810) and for at least 4 months after the last dose. These risks may also apply to CDX-1140
Terms in these criteria, in plain language(25)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study 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.

    Procedure: Biospecimen Collection · Biological: Cemiplimab · Procedure: Computed Tomography · Procedure: Positron Emission Tomography · Procedure: Tumor Resection

  • 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.

    Biological: Anti-CD40 Agonist Monoclonal Antibody CDX-1140 · Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Biological: Cemiplimab · Procedure: Computed Tomography · Procedure: Positron Emission Tomography · Procedure: Tumor Resection

Interventions

  • Given IV

    Also known as: Agonist CD40 Antibody CDX-1140, Anti-CD40 Agonistic Monoclonal Antibody CDX-1140, CDX 1140, CDX-1140

  • ProcedureBiopsy Procedure

    Undergo tumor biopsy

    Also known as: Biopsy, BIOPSY_TYPE, Bx

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • BiologicalCemiplimab

    Given IV

    Also known as: Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN 2810, REGN-2810, REGN2810

  • ProcedureComputed Tomography

    Undergo CT scan

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • ProcedurePositron Emission Tomography

    Undergo PET scan

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

  • ProcedureTumor Resection

    Undergo resection surgery

06

What researchers measure

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

  5. Serum cytokines levels

    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

  6. Circulating tumor deoxyribonucleic acid (ctDNA) levels

    Two-sample t-test, Mann-Whitney U test, or log rank test will be used where appropriate to analyze the correlation between efficacy outcomes. Will also compare ctDNA levels between the two arms and between responders and non-responders using a Student's t-test.

    Time frame: Up to 2 years after surgical resection

  7. Gene expression levels

    Will be assessed using DEseq2, and will also be compared between treatment arms and between those with and without achieving pathologic response.

    Time frame: Day 3 and day 29-36

  8. Gene set enrichment

    Gene set statistics will be run with fgsea using MSigDb61 pathways annotated in the HALLMARK databases.

    Time frame: Up to 2 years after surgical resection

  9. Pharmacokinetic (PK) parameters

    Including clearance and area-under-the-curve, will be calculated for cemiplimab (REGN2810) and CDX-1140 in combination. Impact of baseline and time-varying clearance of cemiplimab (REGN2810) and CDX-1140 in combination will be correlated to efficacy data and AEs to evaluate any PK-related efficacy or toxicity relationship. Also, comparison of observed cemiplimab (REGN2810) PK with historical data will be included.

    Time frame: Up to study completion

07

Study locations

12 of 12 sites recruiting
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
    Irvine, California 92612, United States
    Recruiting
    • Site Public Contact · Contactucstudy@uci.edu · 877-827-8839
    • Victoria M. Villaflor · Principal investigator
  • Los Angeles General Medical Center
    Los Angeles, California 90033, United States
    Recruiting
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
    Recruiting
    • Site Public Contact · Contact323-865-0451
    • Jacob S. Thomas · Principal investigator
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
    Recruiting
    • Site Public Contact · Contactucstudy@uci.edu · 877-827-8839
    • Victoria M. Villaflor · Principal investigator
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
    Recruiting
    • Site Public Contact · Contact888-946-7447
    • Jose A. Monteiro de Oliveira Novaes · Principal investigator
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
    Recruiting
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
    Recruiting
    • Site Public Contact · Contact551-996-2897
    • Robert S. Alter · Principal investigator
  • University of Cincinnati Cancer Center-UC Medical Center
    Cincinnati, Ohio 45219, United States
    Recruiting
    • Site Public Contact · Contactcancer@uchealth.com · 513-584-7698
    • Chad A. Zender · Principal investigator
  • University of Cincinnati Cancer Center-West Chester
    West Chester, Ohio 45069, United States
    Recruiting
    • Site Public Contact · Contactcancer@uchealth.com · 513-584-7698
    • Chad A. Zender · Principal investigator
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
    Recruiting
    • Site Public Contact · Contacttrials@ohsu.edu · 503-494-1080
    • Jeremy P. Cetnar · Principal investigator
  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
    Recruiting
    • Site Public Contact · Contact412-647-8073
    • Kevin J. Contrera · Principal investigator
  • VCU Massey Comprehensive Cancer Center
    Richmond, Virginia 23298, United States
    Recruiting
    • Site Public Contact · ContactCTOclinops@vcu.edu · 804-628-6430
    • Erin R. Alesi · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Data sharing details ↗ · grants.nih.gov

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Nov 2027, 17 months after the start.

Of 298 non-industry phase 2 interventional studies under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 85. This study's planned 17 months is below that.

Counting every sponsor, half of 366 studies reached it within 53 months; a quarter within 35 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2025
First posted
May 20, 2025
StartActual
May 27, 2026
Primary completionEst.
Nov 24, 2027
CompletionEst.
Nov 24, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added
Show site
  • Hackensack University Medical Center · Hackensack, United States
Sep 25, 2026
Show all 2 updates
  1. Oct 26, 2026
    Minor edits only
    + 1 other change: verification date
  2. Sep 25, 2026
    1 site added
    Show site
    • Hackensack University Medical Center · Hackensack, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06980038
Responsible party
Sponsor
First posted
May 20, 2025
Start date
May 27, 2026
Primary completion
Nov 24, 2027 (estimated)
Completion
Nov 24, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Matin Imanguli
principal investigator · JHU Sidney Kimmel Comprehensive Cancer Center LAO

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: CDX-1140

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