Testar a Adição de Cemiplimab (REGN2810) à Quimioterapia Administrada Antes da Cirurgia em Doentes com Carcinoma Espinocelular Sinonasal
Quimioterapia Neoadjuvante Com ou Sem Cemiplimab (REGN2810) no Carcinoma de Células Escamosas Sinonasal: Um Estudo de Fase 2 Randomizado
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
- Medicamento: Carboplatin
- Medicamento: Paclitaxel
- Procedimento: Magnetic Resonance Imaging
- Procedimento: Biopsy Procedure
- Procedimento: Biospecimen Collection
- Procedimento: Positron Emission Tomography
- Radiação: Radiation Therapy
- Procedimento: Surgical Procedure
- Biológico: Cemiplimab
- Medicamento: Carboplatin
- Outro: Chemoradiotherapy
- Medicamento: Cisplatin
- Procedimento: Computed Tomography
Descrição detalhada
PRIMARY OBJECTIVE:
I. To assess whether neoadjuvant therapy (NAT) with cemiplimab (REGN2810)/carboplatin/paclitaxel (Arm 1) results in improved event free survival (EFS) compared to carboplatin/paclitaxel (Arm 2) in participants with sinonasal squamous cell carcinoma (SNSCC).
SECONDARY OBJECTIVES:
I. To compare objective response rate (ORR) between neoadjuvant cemiplimab (REGN2810)/carboplatin/paclitaxel (Arm 1) and neoadjuvant carboplatin/paclitaxel (Arm 2) and to historical standard of care (SOC) in participants with SNSCC.
II. To compare overall survival (OS) between neoadjuvant cemiplimab (REGN2810)/carboplatin/paclitaxel (Arm 1) and carboplatin/paclitaxel (Arm 2) and to historical SOC in participants with SNSCC.
III. To characterize toxicity with NAT in SNSCC. IV. To measure changes in T-cell clonality/diversity using ribonucleic acid (RNA) sequencing (RNAseq) and correlate with NAT response and EFS.
V. To evaluate organ preservation (orbital and skull base) rate with NAT in SNSCC.
CORRELATIVE OBJECTIVES:
I. To correlate human papillomavirus (HPV) status with ORR and OS after NAT. II. To correlate combined positive score (CPS) for PD-L1 expression with OS and EFS.
III. To measure the kinetics of circulating tumor DNA (ctDNA) pre- and post-NAT and correlate with ORR and OS after NAT.
IV. To correlate change in Sinonasal Morbidity Score with ORR and EFS after NAT.
V. To conduct DNA sequencing on pre-treatment tumor biopsies to determine whether features of the tumor genomic landscape are associated with response to NAT.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1:
NAT: Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1 of each cycle, carboplatin IV over 30 minutes on day 1 of each cycle, and paclitaxel IV over 180 minutes on day 1 of each cycle. Cycles repeat every 21 days (3 weeks) for up to 2 cycles (6 weeks) in the absence of disease progression or unacceptable toxicity. At the discretion of the investigator, patients may alternatively receive carboplatin IV over 30 minutes and paclitaxel IV over 60 minutes weekly during the 2, 3-week cycles. Up to 14 days after completion of NAT, patients are evaluated for response and proceed to definitive therapy.
DEFINITIVE THERAPY: Patients with complete response (CR) or partial response (PR) receive concurrent SOC chemoradiotherapy (CRT). Patients with stable disease (SD) or progressive disease (PD) undergo surgery within 6 weeks of completion of NAT followed by SOC adjuvant therapy.
ADJUVANT THERAPY: Within 3-4 weeks of NAT or 4-6 weeks of surgery, patients undergo radiation therapy (RT) once daily, 5 days per week for a total of 30 fractions over 6 weeks and receive cisplatin or carboplatin weekly during RT.
Patients also undergo magnetic resonance imaging (MRI), positron emission tomography (PET)/computed tomography (CT), CT, and collection of blood samples throughout the trial. Patients may undergo biopsy pre-treatment and/or on study.
ARM 2:
NAT: Patients receive carboplatin IV over 30 minutes on day 1 of each cycle and paclitaxel IV over 180 minutes on day 1 of each cycle. Cycles repeat every 21 days (3 weeks) for up to 2 cycles (6 weeks) in the absence of disease progression or unacceptable toxicity. At the discretion of the investigator, patients may alternatively receive carboplatin IV over 30 minutes and paclitaxel IV over 60 minutes weekly during the 2, 3-week cycles. Up to 14 days after completion of NAT, patients are evaluated for response and proceed to definitive therapy.
DEFINITIVE THERAPY: Patients with CR or PR receive concurrent SOC CRT. Patients with SD or PD undergo surgery within 6 weeks of completion of NAT followed by SOC adjuvant therapy.
ADJUVANT THERAPY: Within 4-6 weeks of surgery, patients undergo RT once daily, 5 days per week for a total of 30 fractions over 6 weeks and receive cisplatin or carboplatin weekly during RT.
Patients also undergo MRI, PET/CT, CT, and collection of blood samples throughout the trial. Patients may undergo biopsy pre-treatment and/or on study.
After completion of definitive therapy, patients are followed up at 3, 9, 15, 21, and 27 months and then every 12 months for an additional 3 years (5 years total follow up).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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California
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Irvine, California, Estados Unidos, 92612
- Recrutamento
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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Contato:
- Site Public Contact
- Número de telefone: 877-827-8839
- E-mail: ucstudy@uci.edu
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Investigador principal:
- Edward Kuan
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Los Angeles, California, Estados Unidos, 90033
- Recrutamento
- USC / Norris Comprehensive Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 323-865-0451
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Investigador principal:
- Jacob S. Thomas
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Orange, California, Estados Unidos, 92868
- Recrutamento
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 877-827-8839
- E-mail: ucstudy@uci.edu
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Investigador principal:
- Edward Kuan
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Sacramento, California, Estados Unidos, 95817
- Recrutamento
- University of California Davis Comprehensive Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 916-734-3089
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Investigador principal:
- Shiruyeh Schokrpur
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Recrutamento
- Yale University
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Contato:
- Site Public Contact
- Número de telefone: 203-785-5702
- E-mail: canceranswers@yale.edu
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Investigador principal:
- Aarti Bhatia
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Trumbull, Connecticut, Estados Unidos, 06611
- Recrutamento
- Smilow Cancer Hospital Care Center-Trumbull
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Contato:
- Site Public Contact
- Número de telefone: 203-785-5702
- E-mail: canceranswers@yale.edu
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Investigador principal:
- Aarti Bhatia
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Waterbury, Connecticut, Estados Unidos, 06708
- Recrutamento
- Smilow Cancer Hospital-Waterbury Care Center
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Contato:
- Site Public Contact
- Número de telefone: 203-785-5702
- E-mail: canceranswers@yale.edu
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Investigador principal:
- Aarti Bhatia
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Waterford, Connecticut, Estados Unidos, 06385
- Recrutamento
- Smilow Cancer Hospital Care Center - Waterford
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Contato:
- Site Public Contact
- Número de telefone: 203-785-5702
- E-mail: canceranswers@yale.edu
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Investigador principal:
- Aarti Bhatia
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Florida
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Ruskin, Florida, Estados Unidos, 33570
- Recrutamento
- Moffitt Cancer Center at SouthShore
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Contato:
- Site Public Contact
- Número de telefone: 800-679-0775
- E-mail: ClinicalTrials@moffitt.org
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Investigador principal:
- Jimmy J. Caudell
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Tampa, Florida, Estados Unidos, 33607
- Recrutamento
- Moffitt Cancer Center-International Plaza
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Contato:
- Site Public Contact
- Número de telefone: 800-679-0775
- E-mail: ClinicalTrials@moffitt.org
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Investigador principal:
- Jimmy J. Caudell
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Tampa, Florida, Estados Unidos, 33612
- Recrutamento
- Moffitt Cancer Center - McKinley Campus
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Contato:
- Site Public Contact
- Número de telefone: 800-679-0775
- E-mail: ClinicalTrials@moffitt.org
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Investigador principal:
- Jimmy J. Caudell
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Tampa, Florida, Estados Unidos, 33612
- Recrutamento
- Moffitt Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 800-679-0775
- E-mail: ClinicalTrials@moffitt.org
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Investigador principal:
- Jimmy J. Caudell
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Wesley Chapel, Florida, Estados Unidos, 33544
- Recrutamento
- Moffitt Cancer Center at Wesley Chapel
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Contato:
- Site Public Contact
- Número de telefone: 800-679-0775
- E-mail: ClinicalTrials@moffitt.org
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Investigador principal:
- Jimmy J. Caudell
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Recrutamento
- Emory University Hospital Midtown
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Contato:
- Site Public Contact
- Número de telefone: 888-946-7447
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Investigador principal:
- Jose A. Monteiro de Oliveira Novaes
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- Recrutamento
- University of Kentucky/Markey Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 859-257-3379
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Investigador principal:
- Susanne M. Arnold
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- Recrutamento
- UNC Lineberger Comprehensive Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 877-668-0683
- E-mail: cancerclinicaltrials@med.unc.edu
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Investigador principal:
- Siddharth Sheth
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- Recrutamento
- UPMC Hillman Cancer Center
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Contato:
- Site Public Contact
- Número de telefone: 412-647-8073
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Investigador principal:
- Dan P. Zandberg
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
- Recrutamento
- University of Virginia Cancer Center
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Investigador principal:
- Varinder Kaur
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Contato:
- Site Public Contact
- Número de telefone: 434-243-6303
- E-mail: uvacancertrials@hscmail.mcc.virginia.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
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Patients must have histologically confirmed squamous cell carcinoma of sinonasal origin
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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
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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
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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
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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
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Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
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Hemoglobin ≥ 8 g/dL (acceptable to reach via transfusion)
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Absolute neutrophil count ≥ 1,500/mcL
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Platelets ≥ 100,000/mcL
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Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
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Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 × institutional ULN
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Creatinine clearance ≥ 40 mL/min
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Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
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For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
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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
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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
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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
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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
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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
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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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm 1 (cemiplimab, carboplatin, paclitaxel)
See Detailed Description. |
Given IV
Outros nomes:
Given IV
Outros nomes:
Undergo MRI
Outros nomes:
Undergo biopsy
Outros nomes:
Undergo collection of blood samples
Outros nomes:
Undergo PET/CT
Outros nomes:
Undergo radiation therapy
Outros nomes:
Undergo surgery
Outros nomes:
Given IV
Outros nomes:
Given carboplatin
Outros nomes:
Undergo SOC CRT
Outros nomes:
Given cisplatin
Outros nomes:
Undergo PET/CT and CT
Outros nomes:
|
|
Comparador Ativo: Arm 2 (carboplatin, paclitaxel)
See Detailed Description. |
Given IV
Outros nomes:
Given IV
Outros nomes:
Undergo MRI
Outros nomes:
Undergo biopsy
Outros nomes:
Undergo collection of blood samples
Outros nomes:
Undergo PET/CT
Outros nomes:
Undergo radiation therapy
Outros nomes:
Undergo surgery
Outros nomes:
Given carboplatin
Outros nomes:
Undergo SOC CRT
Outros nomes:
Given cisplatin
Outros nomes:
Undergo PET/CT and CT
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Event free survival (EFS)
Prazo: From randomization to first occurrence of progression of disease or death, assessed up to 5 years
|
Progression will be assessed per Response Evaluation Criteria in Solid Tumors version 1.1. To evaluate EFS, survival functions will be computed using the Kaplan-Meier method and compared between groups using the stratified log-rank test. Adjustment for additional covariates will be performed using Cox proportional hazards regression analysis if numbers allow. |
From randomization to first occurrence of progression of disease or death, assessed up to 5 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall response rate (ORR)
Prazo: Up to 5 years
|
ORR will be defined as complete response + partial response (≥ 30% decrease in tumor volume) per Response Evaluation Criteria in Solid Tumors version 1.1 criteria. ORR will be estimated with a 95% confidence interval using the exact Clopper Pearson method. The ORR will be compared between with neoadjuvant cemiplimab (REGN2810)/carboplatin/paclitaxel (Arm 1) to carboplatin/paclitaxel (Arm 2) using the Cochran-Mantel-Haenszel test, stratified by the same factors used for the primary endpoint. ORR for the aggregate study cohort (Arm 1 + Arm 2) will be compared to historical standard of care using the same analysis plan. |
Up to 5 years
|
|
Incidence of adverse events (AEs) associated with neoadjuvant therapy (NAT)
Prazo: Up to 5 years
|
Both acute toxicities and chronic toxicities will be graded by the treating investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The frequency of participants experiencing a specific AE will be tabulated by dose level, cycle, seriousness, worst severity, timing of occurrence, outcome, and relationship to study drug. In addition, the number and percentage of participants experiencing a specific toxicity will be tabulated similarly. Accrual will be halted if excessive numbers of unacceptable toxicities are observed. This is defined as > 30% grade 4 treatment-related AEs, which are directly attributable to NAT. |
Up to 5 years
|
|
Changes in T-cell clonality/diversity
Prazo: Up to 5 years
|
The changes in T-cell clonality/diversity will be assessed using ribonucleic acid sequencing (RNAseq) and correlated with NAT response and EFS. RNAseq data will undergo quality control, alignment to the human reference genome, and transcript quantification using standard bioinformatics pipelines. T-cell receptor sequences will be reconstructed using tools such as MiXCR or TRUST4. Measures of T-cell clonality and diversity (e.g., Shannon entropy, clonality index) will be calculated. Changes in T-cell clonality/diversity pre- and post-treatment will be assessed using paired t-tests or Wilcoxon signed-rank tests. Associations with NAT response and EFS will be analyzed using logistic regression and Cox proportional hazards models, adjusting for relevant covariates. Multiple testing correction using the Benjamini-Hochberg method will be applied where appropriate. |
Up to 5 years
|
|
Organ preservation rates
Prazo: Up to 5 years
|
Organ preservation in the post-treatment setting is defined as physical and functional preservation of the organ. For example, orbital preservation would imply maintenance of the entirety of the orbit and preservation of vision and motion. Orbital preservation rates will be summarized using descriptive statistics such as mean, standard deviation, median, and range. At the time of enrollment the treating team, with the guidance of the surgical team, will indicate what major anatomic locations would have to be resected if the patient elected initial primary surgical therapy (palate, orbit, and/or skull base). This prospective information will allow concrete subsequent secondary analyses of organ preservation rates without the bias of outcome or recall. |
Up to 5 years
|
|
Overall survival (OS)
Prazo: From the start of NAT to death, assessed up to 5 years
|
The Kaplan-Meier method will be used to estimate OS and 95% confidence intervals will be reported. OS for the aggregate study cohort (Arm 1 + Arm 2) will be compared to historical standard of care using the same analysis plan. |
From the start of NAT to death, assessed up to 5 years
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
OS
Prazo: From the start of NAT to death, assessed up to 5 years
|
Will correlate human papillomavirus status, combined positive score for PD-L1 expression, and circulating tumor deoxyribonucleic acid (ctDNA) with OS. |
From the start of NAT to death, assessed up to 5 years
|
|
EFS
Prazo: From randomization to first occurrence of progression of disease or death, assessed up to 5 years
|
Will correlate human papillomavirus status, combined positive score for PD-L1 expression, and ctDNA with EFS. |
From randomization to first occurrence of progression of disease or death, assessed up to 5 years
|
|
NAT response rates
Prazo: Up to 5 years
|
Will correlate human papillomavirus status, combined positive score for PD-L1 expression, and ctDNA with NAT response rates. |
Up to 5 years
|
|
ctDNA
Prazo: At pre-treatment, in weeks 7-8 (post-NAT visit), and at 3 months following definitive treatment
|
ctDNA will be measured at pre-defined timepoints. Sequencing using whole exome sequencing will be conducted on pre-treatment tissue. |
At pre-treatment, in weeks 7-8 (post-NAT visit), and at 3 months following definitive treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Siddharth Sheth, Ohio State University Comprehensive Cancer Center LAO
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Produtos químicos orgânicos
- Técnicas de investigação
- Terapêutica
- Técnicas de laboratório clínico
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Terapia medicamentosa
- Técnicas citológicas
- Citodiagnóstico
- Hidrocarbonetos
- Cicloparaffinas
- Hidrocarbonetos, aliciclicos
- Hidrocarbonetos, cíclicos
- Terpenos
- Fenômenos físicos
- Produtos químicos inorgânicos
- Compostos de cloro
- Compostos de nitrogênio
- Complexos de coordenação
- Taxóides
- Ciclodecanos
- Diterpenos
- Elementos
- Metais
- Economia de saúde e organizações
- Técnicas de diagnóstico, cirúrgico
- Técnicas de química, analíticas
- Análise de espectro
- Metais, pesados
- Compostos de platina
- Elementos de transição
- Terapia de modalidade combinada
- Economia
- Carboplatina
- Paclitaxel
- Cisplatina
- Citrato de 1,2-diaminociclohexanoplatina II
- Radioterapia
- Radiação
- Biópsia
- Manipulação de amostras
- Espectroscopia de ressonância magnética
- Procedimentos cirúrgicos, operatórios
- Platina
- Quimiorradioterapia
- cemiplimab
- Impostos
Outros números de identificação do estudo
- NCI-2025-09016
- UM1CA186712 (Concessão/Contrato do NIH dos EUA)
- 10721 (Outro identificador: CTEP)
- NCI-2025-09016 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 10721 (Outro identificador: Ohio State University Comprehensive Cancer Center LAO)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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