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Prueba de inmunoterapia con nivolumab e ipilimumab con o sin el fármaco dirigido cabozantinib en cáncer de nasofaringe recurrente, metastásico o incurable

30 de octubre de 2026 actualizado por: National Cancer Institute (NCI)

Estudio aleatorizado de fase 2 de nivolumab e ipilimumab con o sin cabozantinib en pacientes con carcinoma nasofaríngeo avanzado que han progresado después del tratamiento con platino e inmunoterapia

This phase II trial tests how well nivolumab and ipilimumab immunotherapy with or without cabozantinib works in treating patients with nasopharyngeal cancer that has come back (after a period of improvement) (recurrent), has spread from where it first started (primary site) to other places in the body (metastatic), or for which no treatment is currently available (incurable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving immunotherapy with nivolumab and ipilimumab and targeted therapy with cabozantinib may help shrink and stabilize nasopharyngeal cancer.

Descripción general del estudio

Estado

Suspendido

Condiciones

Intervención / Tratamiento

Descripción detallada

PRIMARY OBJECTIVE:

I. To determine if the progression-free survival (PFS) of the triplet combination (cabozantinib S-malate, nivolumab, and ipilimumab [CaboNivoIpi]) is more favorable than the doublet (nivolumab and ipilimumab [NivoIpi]).

SECONDARY OBJECTIVES:

I. To compare safety and tolerability between the two arms (Common Terminology Criteria for Adverse Events [CTCAE] version [v]5.0.).

II. To compare overall response rate (ORR) between the two arms via both Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and immune-modified Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.

III. To compare overall survival (OS) between the two arms. IV. To assess response by primary or acquired PD-1/L1 inhibitor resistance in the prior line of therapy.

EXPLORATORY OBJECTIVE:

I. To evaluate molecular and immunologic predictors of response (Epstein-Barr virus [EBV] viral load; PD-L1 score) between arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial.

ARM B: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 and cabozantinib S-malate orally (PO) daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may continue with cabozantinib S-malate after 2 years per treating investigator. Patients undergo CT or MRI and collection of blood samples throughout the trial.

After completion of study treatment, patients are followed up every 8-12 weeks until progression of disease occurs or a new non-protocol anti-cancer therapy is initiated and then every 6 months for up to 2 years.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Irvine, California, Estados Unidos, 92612
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
      • Los Angeles, California, Estados Unidos, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, Estados Unidos, 90020
        • Keck Medicine of USC Koreatown
      • Los Angeles, California, Estados Unidos, 90033
        • Los Angeles General Medical Center
      • Newport Beach, California, Estados Unidos, 92663
        • USC Norris Oncology/Hematology-Newport Beach
      • Orange, California, Estados Unidos, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Palo Alto, California, Estados Unidos, 94304
        • Stanford Cancer Institute Palo Alto
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30308
        • Emory University Hospital Midtown
    • Idaho
      • Boise, Idaho, Estados Unidos, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell, Idaho, Estados Unidos, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, Estados Unidos, 83814
        • Kootenai Health - Coeur d'Alene
      • Nampa, Idaho, Estados Unidos, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls, Idaho, Estados Unidos, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, Estados Unidos, 83864
        • Kootenai Clinic Cancer Services - Sandpoint
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University
      • Chicago, Illinois, Estados Unidos, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Estados Unidos, 60612
        • University of Illinois
      • Danville, Illinois, Estados Unidos, 61832
        • Carle at The Riverfront
      • DeKalb, Illinois, Estados Unidos, 60115
        • Northwestern Medicine Cancer Center Kishwaukee
      • Effingham, Illinois, Estados Unidos, 62401
        • Carle Physician Group-Effingham
      • Evanston, Illinois, Estados Unidos, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Geneva, Illinois, Estados Unidos, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, Estados Unidos, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Glenview, Illinois, Estados Unidos, 60026
        • Northwestern Medicine Glenview Outpatient Center
      • Grayslake, Illinois, Estados Unidos, 60030
        • Northwestern Medicine Grayslake Outpatient Center
      • Harvey, Illinois, Estados Unidos, 60426
        • Ingalls Memorial Hospital
      • Highland Park, Illinois, Estados Unidos, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Lake Forest, Illinois, Estados Unidos, 60045
        • Northwestern Medicine Lake Forest Hospital
      • Mattoon, Illinois, Estados Unidos, 61938
        • Carle Physician Group-Mattoon/Charleston
      • New Lenox, Illinois, Estados Unidos, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • Orland Park, Illinois, Estados Unidos, 60462
        • University of Chicago Medicine-Orland Park
      • Orland Park, Illinois, Estados Unidos, 60462
        • Northwestern Medicine Orland Park
      • Urbana, Illinois, Estados Unidos, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, Estados Unidos, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Iowa
      • Ankeny, Iowa, Estados Unidos, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Clive, Iowa, Estados Unidos, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Estados Unidos, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Council Bluffs, Iowa, Estados Unidos, 51503
        • Heartland Oncology and Hematology LLP
      • Council Bluffs, Iowa, Estados Unidos, 51503
        • Methodist Jennie Edmundson Hospital
      • Council Bluffs, Iowa, Estados Unidos, 51503
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ
      • Des Moines, Iowa, Estados Unidos, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Estados Unidos, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Estados Unidos, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, Estados Unidos, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Waukee, Iowa, Estados Unidos, 50263
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02111
        • Tufts Medical Center
    • Minnesota
      • Bemidji, Minnesota, Estados Unidos, 56601
        • Sanford Joe Lueken Cancer Center
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63128
        • Mercy Hospital South
    • Montana
      • Anaconda, Montana, Estados Unidos, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, Estados Unidos, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, Estados Unidos, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, Estados Unidos, 59405
        • Benefis Sletten Cancer Institute
      • Kalispell, Montana, Estados Unidos, 59901
        • Logan Health Medical Center
      • Missoula, Montana, Estados Unidos, 59804
        • Community Medical Center
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Estados Unidos, 68114
        • Oncology Associates PC
      • Omaha, Nebraska, Estados Unidos, 68114
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
    • New Jersey
      • Basking Ridge, New Jersey, Estados Unidos, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, Estados Unidos, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, Estados Unidos, 07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack, New York, Estados Unidos, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, Estados Unidos, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, Estados Unidos, 10065
        • Memorial Sloan Kettering Cancer Center
      • Uniondale, New York, Estados Unidos, 11553
        • Memorial Sloan Kettering Nassau
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, Estados Unidos, 28204
        • Novant Health Presbyterian Medical Center
      • Huntersville, North Carolina, Estados Unidos, 28078
        • Novant Health Cancer Institute - Huntersville
      • Matthews, North Carolina, Estados Unidos, 28105
        • Novant Health Cancer Institute - Matthews
      • Mooresville, North Carolina, Estados Unidos, 28117
        • Novant Health Cancer Institute - Mooresville
    • North Dakota
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Estados Unidos, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, Estados Unidos, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45220
        • Good Samaritan Hospital - Cincinnati
    • Oklahoma
      • Lawton, Oklahoma, Estados Unidos, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Estados Unidos, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Ontario, Oregon, Estados Unidos, 97914
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health and Science University
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, Estados Unidos, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Estados Unidos, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, Estados Unidos, 23298
        • VCU Massey Comprehensive Cancer Center
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26506
        • West Virginia University Healthcare
      • Parkersburg, West Virginia, Estados Unidos, 26101
        • Camden Clark Medical Center
    • Wisconsin
      • Eau Claire, Wisconsin, Estados Unidos, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Marshfield, Wisconsin, Estados Unidos, 54449
        • Marshfield Medical Center-Marshfield
      • Minocqua, Wisconsin, Estados Unidos, 54548
        • Marshfield Medical Center - Minocqua
      • Rice Lake, Wisconsin, Estados Unidos, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, Estados Unidos, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Weston, Wisconsin, Estados Unidos, 54476
        • Marshfield Medical Center - Weston

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients must have histologically documented nasopharyngeal carcinoma (NPC) regardless of World Health Organization (WHO) classification (keratinizing squamous cell carcinoma, non-keratinizing, or basaloid squamous cell carcinoma) and regardless of association with Epstein-Barr virus (EBV) and/or human papillomavirus (HPV)

  • Recurrent, metastatic and incurable disease treated with platinum-gemcitabine and prior PD-1/L1 blockade (as first or second-line therapy)

  • Patients are eligible regardless of prior smoking history, p16 immunohistochemistry (IHC) status, PD-L1 expression status, EBV tumor status, EBV viral load at baseline, or tumor genomic alteration status

  • Patients must have at least one measurable lesion (by RECIST v1.1) which has not been previously irradiated that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions as >= 10 mm (>= 1 cm) (and short axis for nodal lesions, LN >= 15 mm) with CT scan, MRI, or calipers by clinical exam

  • Patients may have had no more than 2 prior lines of prior systemic therapy for recurrent, metastatic NPC

  • No prior VEGFR targeted therapy permitted

  • Age >= 18 years

  • Eastern Cooperative Oncology Group Performance (ECOG) performance status 0-2

  • Absolute neutrophil count (ANC) >= 1,000/mm^3

  • Hemoglobin >= 9 g/dL

  • Platelet count >= 100,000/mm^3

  • Creatinine or creatinine clearance =< 1.5 mg/dL or >= 30 Modification of Diet in Renal Disease (MDRD)

  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN); except subjects with Gilbert syndrome who can have a total bilirubin < 3 mg/dL

  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGT]) =< 3 x upper limit of normal (ULN)

    • Up to =< 5 allowed with liver metastases

  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test, per institution standard, done =< 7 days prior to registration is required.

    • Pregnant women are excluded from this study because nivolumab, ipilimumab, and cabozantinib are all Class C or D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants, secondary to treatment of the mother with any of the study agents, breastfeeding should be discontinued if the mother is treated with as part of this study (in either arm)

  • No active tumor bleeding: or radiographic evidence of major blood vessel infiltration as judged by the treating investigator

  • Prior -anti-cancer therapy is allowed: Patients need to be recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1), with the exception of alopecia. Any life-threatening events clearly attributable to prior immunotherapy exposure that have a high possibility of recurring should warrant exclusion: including severe pneumonitis, grade 4 bullous dermatitis/drug reaction with eosinophilia and systemic symptoms (DRESS), neurologic events such as autoimmune encephalitis transverse myelitis, and/or myocarditis. Maintenance hormonal replacement or long-term hormonal therapy exposure is permitted.

    • No chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration. Palliative (limited-field) radiation therapy is permitted, if all of the following criteria are met:

      • Repeat imaging demonstrates no new sites of bone metastases.
      • The lesion being considered for palliative radiation is not a target lesion

  • No patients with a prior malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen

  • Brain metastases allowed: Patients with treated brain metastases are eligible if follow-up brain imaging 3 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial

  • For patients with evidence of chronic hepatitis B (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 receiving treatment, they are eligible if they have an undetectable HCV viral load

  • Solid organ or tissue transplant is allowed: - subsequent therapy with nivolumab increases the risk of organ/tissue rejection. Patients must be instructed that it is crucial they stay in touch with their transplant team during treatment

  • No active autoimmune disease: or history of autoimmune disease that might recur, and which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of

    • Immune related neurologic disease,
    • Multiple sclerosis,
    • Autoimmune (demyelinating) neuropathy,
    • Guillain-Barre syndrome (GBS),
    • Myasthenia gravis;
    • Systemic autoimmune disease such as SLE,
    • Connective tissue diseases,
    • Scleroderma, inflammatory bowel disease (IBD),
    • Crohn's, ulcerative colitis,
    • Patients with a history of toxic epidermal necrolysis (TEN),
    • Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease

  • Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible

  • Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome, and psoriasis controlled with topical medication and patients with only positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible

  • Pneumonitis should be evaluated for the nature of the disease process, need for treatment prior study treatment, and the risk of exacerbation with study treatment

  • Able to swallow oral medication: No known medical condition causing an inability to swallow oral formulations of agents

  • No condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study registration. Patients are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses > 10 mg daily prednisone are permitted. A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted

  • Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel) is prohibited. Allowed anticoagulants are the following:

    • Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
    • Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor

  • Concomitant use of any medications or substances that are strong inhibitors or inducers of CYP3A4 is discouraged; if unavoidable, the dose of cabozantinib on study should be adjusted accordingly. Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) intended to treat the disease under study are prohibited

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Arm A (nivolumab, ipilimumab)

Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI and collection of blood samples throughout the trial.
Biológico: Ipilimumab

Given IV

Otros nombres:
  • Anticuerpo monoclonal anti-antígeno-4 asociado a linfocitos T citotóxicos
  • BMS-734016
  • Ipilimumab Biosimilar CS1002
  • MDX-010
  • MDX-CTLA4
  • Yervoy
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
Procedimiento: Magnetic Resonance Imaging

Undergo MRI

Otros nombres:
  • Resonancia magnética
  • Resonancia magnetica
  • Exploración de imágenes por resonancia magnética
  • Imágenes Médicas, Resonancia Magnética / Resonancia Magnética Nuclear
  • SRES
  • Imágenes de RM
  • Imágenes de RMN
  • RMN
  • Imágenes de resonancia magnética nuclear
  • Imágenes por resonancia magnética (IRM)
  • resonancia magnética nuclear
  • Imágenes por resonancia magnética (procedimiento)
  • Resonancias magnéticas
  • Resonancia magnética estructural
Biológico: Nivolumab

Given IV

Otros nombres:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • MDX1106
  • BMS 936558
  • ABC 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
  • BMS936558
  • ONO 4538
  • ONO4538
Procedimiento: Biospecimen Collection

Undergo collection of blood samples

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Procedimiento: Computed Tomography

Undergo CT scan

Otros nombres:
  • Connecticut
  • GATO
  • Análisis de gato
  • Tomografía Axial Computarizada
  • Tomografía axial computarizada
  • Tomografía computarizada
  • tomografía
  • Tomografía axial computarizada (procedimiento)
  • Tomografía computarizada (TC)
  • Escaneo de gato de diagnóstico
  • Tipo de servicio de escaneo de gato de diagnóstico
Experimental: Arm B (nivolumab, ipilimumab, cabozantinib)

Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 and cabozantinib S-malate PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may continue with cabozantinib S-malate after 2 years per treating investigator. Patients undergo CT or MRI and collection of blood samples throughout the trial.
Biológico: Ipilimumab

Given IV

Otros nombres:
  • Anticuerpo monoclonal anti-antígeno-4 asociado a linfocitos T citotóxicos
  • BMS-734016
  • Ipilimumab Biosimilar CS1002
  • MDX-010
  • MDX-CTLA4
  • Yervoy
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
Procedimiento: Magnetic Resonance Imaging

Undergo MRI

Otros nombres:
  • Resonancia magnética
  • Resonancia magnetica
  • Exploración de imágenes por resonancia magnética
  • Imágenes Médicas, Resonancia Magnética / Resonancia Magnética Nuclear
  • SRES
  • Imágenes de RM
  • Imágenes de RMN
  • RMN
  • Imágenes de resonancia magnética nuclear
  • Imágenes por resonancia magnética (IRM)
  • resonancia magnética nuclear
  • Imágenes por resonancia magnética (procedimiento)
  • Resonancias magnéticas
  • Resonancia magnética estructural
Droga: Cabozantinib S-malate

Given PO

Otros nombres:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
Biológico: Nivolumab

Given IV

Otros nombres:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • MDX1106
  • BMS 936558
  • ABC 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
  • BMS936558
  • ONO 4538
  • ONO4538
Procedimiento: Biospecimen Collection

Undergo collection of blood samples

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Procedimiento: Computed Tomography

Undergo CT scan

Otros nombres:
  • Connecticut
  • GATO
  • Análisis de gato
  • Tomografía Axial Computarizada
  • Tomografía axial computarizada
  • Tomografía computarizada
  • tomografía
  • Tomografía axial computarizada (procedimiento)
  • Tomografía computarizada (TC)
  • Escaneo de gato de diagnóstico
  • Tipo de servicio de escaneo de gato de diagnóstico

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free survival (PFS)
Periodo de tiempo: From randomization to the first of either progression or death from any cause, or censored at last known tumor assessment date, assessed up to 2 years

PFS will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.
From randomization to the first of either progression or death from any cause, or censored at last known tumor assessment date, assessed up to 2 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall survival (OS)
Periodo de tiempo: From randomization to death from any cause, or censored at last known follow-up, assessed up to 2 years

OS will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.
From randomization to death from any cause, or censored at last known follow-up, assessed up to 2 years
Incidence of adverse events
Periodo de tiempo: Up to 2 years

The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the chi-square or Fisher's exact test.
Up to 2 years
Response by subgroups of interest
Periodo de tiempo: Up to 2 years

Will also report and compare the overall response rate (ORR) between different subgroups of interest (primary or acquired PD-1/L1 inhibitor resistance in the prior line of therapy (further defined below), etc.). These comparisons will be done via chi-square or Fisher's exact tests. We'll also assess primary versus acquired resistance to prior PD-1 inhibition in each arm as well. While not a formal stratification, in the interim and final analysis we'll also descriptively assess these subgroups between arms as well.
Up to 2 years
ORR
Periodo de tiempo: Up to 2 years

The response rate will be compared via chi-square or Fisher's exact tests between the 2 treatment arms using both the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and also separately for the immune-modified RECIST criteria.
Up to 2 years
Predictors of response
Periodo de tiempo: Up to 2 years

Will correlate the baseline data (Epstein-Barr virus viral load, p16 immunohistochemistry status, smoking history, and PD-L1 score) with ORR data. For this analysis, logistic regression models will be assessed using the baseline data to predict binary response data. Odds ratios and 95% confidence intervals will be reported. Will also summarize the data using descriptive statistics and graphical methods.
Up to 2 years

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Ari J Rosenberg, Alliance for Clinical Trials in Oncology

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

19 de febrero de 2024

Finalización primaria (Estimado)

6 de diciembre de 2028

Finalización del estudio (Estimado)

6 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2023

Primero enviado que cumplió con los criterios de control de calidad

13 de junio de 2023

Publicado por primera vez (Actual)

15 de junio de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NCI-2023-04469
  • U10CA180821 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2023-04469 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • A092105 (Otro identificador: CTEP)
  • A092105 (Otro identificador: Alliance for Clinical Trials in Oncology)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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