Recruiting
Phase 2

Carboplatin & Paclitaxel

Sponsor:

National Cancer Institute (NCI)

Code:

NCT07281417

Conditions

Sinonasal Squamous Cell Carcinoma

Stage III Sinonasal Cancer AJCC v8

Stage IVA Sinonasal Cancer AJCC v8

Stage IVB Sinonasal Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy Procedure

Biospecimen Collection

Carboplatin

Carboplatin

Cemiplimab

Study Details

Brief summary:

This phase II trial compares the effect of chemotherapy (carboplatin and paclitaxel) with versus without cemiplimab given before surgery (neoadjuvant) in patients with sinonasal squamous cell cancer. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. 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. The usual approach for patients with sinonasal squamous cell cancer is surgery followed by radiation therapy, with or without chemotherapy. Recently, some patients have also been treated with neoadjuvant chemotherapy before surgery. Adding cemiplimab to chemotherapy before surgery may be more effective at stopping the cancer from growing or spreading, compared to chemotherapy alone.

Conditions

Sinonasal Squamous Cell Carcinoma

Stage III Sinonasal Cancer AJCC v8

Stage IVA Sinonasal Cancer AJCC v8

Stage IVB Sinonasal Cancer AJCC v8

Study ID

NCT07281417

Start date

Sep 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 16, 2030

Anticipated

Primary completion date

Dec 16, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have histologically confirmed squamous cell carcinoma of sinonasal origin
  • Patients must have a T stage (T3, T4a, and select T4b) primary tumor according to American Joint Committee on Cancer (AJCC) 8th edition. 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
  • No evidence of metastatic disease determined by pre-treatment imaging. Metastatic disease to neck nodes is considered locally advanced and therefore allowable. Patients with N0 and N1-3 disease will be eligible
  • Known HPV status (i.e., HPV negative, p16 immunohistochemistry \[IHC\] positive, high risk \[HR\]-HPV in situ hybridization \[ISH\] positive) from testing performed prior to referral. HPV status data (e.g., date of test, type of test \[p16 IHC or HR-HPV ISH\] and testing result) must be collected during enrollment. Patients who do not have this information available for collection will not be enrolled on this study
  • Age ≥ 18 years

  • Because no dosing or adverse event data are currently available on the use of cemiplimab (REGN2810) in combination with carboplatin and paclitaxel in patients < 18 years of age, children are excluded from this study
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
  • Hemoglobin ≥ 8 g/dL (acceptable to reach via transfusion)
  • Absolute neutrophil count ≥ 1,500/mcL
  • Platelets ≥ 100,000/mcL
  • Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 × institutional ULN
  • Creatinine clearance ≥ 40 mL/min
  • Human immunodeficiency virus (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 hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C 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 a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • 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 New York Heart Association 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-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. For this reason and because paclitaxel is a class D agent with the potential for teratogenic or abortifacient effects, women of childbearing potential (WCBP) and men should use highly effective contraception during treatment and for 6 months after the last dose of the study drugs. WCBP and men should avoid donating eggs/sperm during treatment and for 6 months after the last dose of the study drugs. Women should discontinue nursing during treatment and for 6 months after the last dose of the study drugs
  • Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
  • Prior to enrollment, verification of payment coverage by insurance (or other payment) for neoadjuvant paclitaxel and carboplatin chemotherapy must be obtained

Exclusion Criteria:

  • Patients with unresectable disease
  • Patients presenting with T3 disease without the need for maxillectomy and/or orbital invasion requiring orbital dissection/resection
  • Patients who have had any previous systemic therapy to the index lesion in the past 12 months. This includes cemiplimab (REGN2810) and/or other immune modulating agents. Previous systemic therapy may alter or affect response
  • Patients who had palliative RT (< 20 Gy) within 1 week prior to entering the study
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs)
  • History of pneumonitis within the last 5 years
  • Patients who have not recovered from adverse events (AEs) 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
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cemiplimab (REGN2810) or carboplatin and paclitaxel
  • 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). Men and WCBP who are not prepared to use highly effective contraception during and for 6 months after completion of treatment are excluded from this study

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 (cemiplimab, carboplatin, paclitaxel)

See Detailed Description.

active comparator: Arm 2 (carboplatin, paclitaxel)

See Detailed Description.

Interventions

Biopsy Procedure

Undergo biopsy

Biospecimen Collection

Undergo collection of blood samples

Carboplatin

Given IV

Carboplatin

Given carboplatin

Cemiplimab

Given IV

Chemoradiotherapy

Undergo SOC CRT

Cisplatin

Given cisplatin

Computed Tomography

Undergo PET/CT and CT

Magnetic Resonance Imaging

Undergo MRI

Paclitaxel

Given IV

Positron Emission Tomography

Undergo PET/CT

Radiation Therapy

Undergo radiation therapy

Surgical Procedure

Undergo surgery

Primary outcome measure

  • Event free survival (EFS) [ Time Frame: From randomization to first occurrence of progression of disease or death, assessed up to 5 years ]

Central Contacts and Locations

Locations

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Edward Kuan

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Site Public Contact

323-865-0451

Principal Investigator:

Jacob S. Thomas

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Edward Kuan

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Shiruyeh Schokrpur

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Aarti Bhatia

Smilow Cancer Hospital Care Center-Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Aarti Bhatia

Smilow Cancer Hospital-Waterbury Care Center

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Aarti Bhatia

Smilow Cancer Hospital Care Center - Waterford

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

Site Public Contact

203-785-5702canceranswers@yale.edu

Principal Investigator:

Aarti Bhatia

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Site Public Contact

800-679-0775ClinicalTrials@moffitt.org

Principal Investigator:

Jimmy J. Caudell

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Jose A. Monteiro de Oliveira Novaes

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Susanne M. Arnold

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Site Public Contact

877-668-0683cancerclinicaltrials@med.unc.edu

Principal Investigator:

Siddharth Sheth

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Dan P. Zandberg

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Site Public Contact

434-243-6303uvacancertrials@hscmail.mcc.virginia.edu

Principal Investigator:

Varinder Kaur

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-04.