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Prueba de la adición de nivolumab a la quimioterapia en el tratamiento del sarcoma de tejido blando

11 de noviembre de 2026 actualizado por: National Cancer Institute (NCI)

Un ensayo multicéntrico de fase II de paclitaxel con y sin nivolumab en taxanos sin tratamiento previo, y nivolumab y cabozantinib en sujetos con angiosarcoma tratados previamente con taxanos

This phase II trial studies how well paclitaxel with and without nivolumab works in treating patients with soft tissue sarcoma that have not received taxane drugs, and how well nivolumab and cabozantinib work in treating taxane pretreated patients with soft tissue sarcoma. Nivolumab works through the body's immune system to help the immune system act against tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is being done to see if the combination of nivolumab and paclitaxel or cabozantinib can shrink soft tissue sarcoma and possibly prevent it from coming back.

Descripción general del estudio

Estado

Estado

Indica el estado de contratación actual o el estado de acceso ampliado.
Activo, no reclutando

Condiciones

Condiciones

La enfermedad, trastorno, síndrome, dolencia o lesión que se está estudiando. En ClinicalTrials.gov, las condiciones también pueden incluir otros problemas relacionados con la salud, como la esperanza de vida, la calidad de vida y los riesgos para la salud.

Intervención / Tratamiento

Intervención / Tratamiento

Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.

Descripción detallada

PRIMARY OBJECTIVES:

I. To determine the progression free survival (PFS) for paclitaxel with and without nivolumab in subjects with taxane naive angiosarcoma.

II. To determine the overall response rate (ORR) of nivolumab in combination with cabozantinib S-malate (cabozantinib) in patients with taxane pre-treated angiosarcoma.

SECONDARY OBJECTIVES:

I. To determine the ORR of paclitaxel in combination with nivolumab. II. To determine clinical activity of the addition of nivolumab to paclitaxel or cabozantinib in subjects with angiosarcoma by determination of overall survival (OS) for each combination.

III. To determine clinical activity of the addition of nivolumab to cabozantinib in subjects with taxane pre-treated angiosarcoma by determination of progression free survival (PFS) at 6 months by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria.

IV. To assess toxicity of the concurrent nivolumab-paclitaxel and nivolumab-cabozantinib combinations in subjects with angiosarcoma based on National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.

V. To measure symptomatic adverse events (AE) for patients via Patient Reported Outcome (PRO)-CTCAE, Functional Assessment of Cancer Therapy General (FACT-G) questionnaire, and Linear Analogue Self-Assessment (LASA).

OUTLINE: Patients who have not previously received a taxane are randomized to Arm I or Arm II. Patients who have previously received a taxane are assigned to Arm III.

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve complete response (CR), partial response (PR) or stable disease (SD) on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm III.

ARM III (EFFECTIVE OF 10/28/2021, NEW PATIENT ACCRUAL PERMANENTLY CLOSED): Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib orally (PO) daily. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity.

Patients also undergo collection of blood at baseline and on study, computed tomography (CT) scan, spiral CT, or magnetic resonance imaging (MRI), or FDG-positron emission tomography (FDG-PET) scan throughout the trial.

After completion of study treatment, patients are followed up every 3 months for 3 years.

Tipo de estudio

Tipo de estudio

Describe la naturaleza de un estudio clínico. Los tipos de estudio incluyen estudios de intervención (también llamados ensayos clínicos), estudios observacionales (incluidos registros de pacientes) y acceso ampliado.
Intervencionista

Inscripción (Actual)

Inscripción

El número de participantes en un estudio clínico. La inscripción "anticipada" es el número objetivo de participantes que los investigadores necesitan para el estudio.
90

Fase

Fase

La etapa de un ensayo clínico que estudia un fármaco o producto biológico, según las definiciones desarrolladas por la Administración de Drogas y Alimentos de los Estados Unidos (FDA). La fase se basa en el objetivo del estudio, el número de participantes y otras características. Hay cinco fases: Fase 1 temprana (anteriormente enumerada como Fase 0), Fase 1, Fase 2, Fase 3 y Fase 4. No aplicable se usa para describir ensayos sin fases definidas por la FDA, incluidos ensayos de dispositivos o intervenciones conductuales.
  • 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
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85054
        • Mayo Clinic Hospital in Arizona
      • Scottsdale, Arizona, Estados Unidos, 85259
        • Mayo Clinic in Arizona
      • Tucson, Arizona, Estados Unidos, 85704
        • University of Arizona Cancer Center-Orange Grove Campus
      • Tucson, Arizona, Estados Unidos, 85719
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, Estados Unidos, 85719
        • University of Arizona Cancer Center-North Campus
    • Arkansas
      • Fort Smith, Arkansas, Estados Unidos, 72903
        • Mercy Hospital Fort Smith
    • California
      • Duarte, California, Estados Unidos, 91010
        • City of Hope Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • UCHealth University of Colorado Hospital
    • Connecticut
      • Derby, Connecticut, Estados Unidos, 06418
        • Smilow Cancer Hospital-Derby Care Center
      • Fairfield, Connecticut, Estados Unidos, 06824
        • Smilow Cancer Hospital Care Center-Fairfield
      • Glastonbury, Connecticut, Estados Unidos, 06033
        • Smilow Cancer Hospital Care Center at Glastonbury
      • Greenwich, Connecticut, Estados Unidos, 06830
        • Smilow Cancer Hospital Care Center at Greenwich
      • Guilford, Connecticut, Estados Unidos, 06437
        • Smilow Cancer Hospital Care Center - Guilford
      • Hartford, Connecticut, Estados Unidos, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • New Haven, Connecticut, Estados Unidos, 06520
        • Yale University
      • North Haven, Connecticut, Estados Unidos, 06473
        • Yale-New Haven Hospital North Haven Medical Center
      • Orange, Connecticut, Estados Unidos, 06477
        • Smilow Cancer Hospital-Orange Care Center
      • Torrington, Connecticut, Estados Unidos, 06790
        • Smilow Cancer Hospital-Torrington Care Center
      • Trumbull, Connecticut, Estados Unidos, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
      • Waterbury, Connecticut, Estados Unidos, 06708
        • Smilow Cancer Hospital-Waterbury Care Center
      • Waterford, Connecticut, Estados Unidos, 06385
        • Smilow Cancer Hospital Care Center - Waterford
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20016
        • Sibley Memorial Hospital
    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • UF Health Cancer Institute - Gainesville
      • Jacksonville, Florida, Estados Unidos, 32224-9980
        • Mayo Clinic in Florida
      • Tampa, Florida, Estados Unidos, 33612
        • Moffitt Cancer Center
      • Tampa, Florida, Estados Unidos, 33607
        • Moffitt Cancer Center-International Plaza
      • Tampa, Florida, Estados Unidos, 33612
        • Moffitt Cancer Center - McKinley Campus
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30308
        • Emory University Hospital Midtown
    • Hawaii
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Estados Unidos, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, Estados Unidos, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Estados Unidos, 96817
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, Estados Unidos, 96817
        • Kuakini Medical Center
      • Honolulu, Hawaii, Estados Unidos, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, Estados Unidos, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Island Urology
      • Honolulu, Hawaii, Estados Unidos, 96817
        • Hawaii Diagnostic Radiology Services LLC
      • Kahului, Hawaii, Estados Unidos, 96732
        • Straub Medical Center - Kahului Clinic
      • Kailua, Hawaii, Estados Unidos, 96734
        • Castle Medical Center
      • Lihue, Hawaii, Estados Unidos, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • ‘Aiea, Hawaii, Estados Unidos, 96701
        • Hawaii Cancer Care - Westridge
      • ‘Aiea, Hawaii, Estados Unidos, 96701
        • Pali Momi Medical Center
      • ‘Aiea, Hawaii, Estados Unidos, 96701
        • Queen's Cancer Center - Pearlridge
      • ‘Aiea, Hawaii, Estados Unidos, 96701
        • The Cancer Center of Hawaii-Pali Momi
      • ‘Ewa Beach, Hawaii, Estados Unidos, 96706
        • The Queen's Medical Center - West Oahu
    • Illinois
      • Alton, Illinois, Estados Unidos, 62002
        • OSF Saint Anthony's Health Center
      • Aurora, Illinois, Estados Unidos, 60504
        • Rush-Copley Medical Center
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University
      • Chicago, Illinois, Estados Unidos, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Estados Unidos, 60612
        • Rush MD Anderson Cancer Center
      • 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
      • 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
      • Mount Vernon, Illinois, Estados Unidos, 62864
        • SSM Health Good Samaritan
      • Urbana, Illinois, Estados Unidos, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Estados Unidos, 61801
        • The Carle Foundation Hospital
      • Warrenville, Illinois, Estados Unidos, 60555
        • Northwestern Medicine Cancer Center Warrenville
      • Yorkville, Illinois, Estados Unidos, 60560
        • Rush-Copley Healthcare Center
    • Indiana
      • Fort Wayne, Indiana, Estados Unidos, 46845
        • Parkview Regional Medical Center
    • Iowa
      • Ames, Iowa, Estados Unidos, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, Estados Unidos, 50010
        • McFarland Clinic - Ames
      • Boone, Iowa, Estados Unidos, 50036
        • McFarland Clinic - Boone
      • Fort Dodge, Iowa, Estados Unidos, 50501
        • McFarland Clinic - Trinity Cancer Center
      • Jefferson, Iowa, Estados Unidos, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Estados Unidos, 50158
        • McFarland Clinic - Marshalltown
    • Kansas
      • Garden City, Kansas, Estados Unidos, 67846
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, Estados Unidos, 67530
        • Central Care Cancer Center - Great Bend
    • Louisiana
      • Shreveport, Louisiana, Estados Unidos, 71103
        • LSU Health Sciences Center at Shreveport
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Estados Unidos, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • University of Michigan Rogel Cancer Center
    • Minnesota
      • Burnsville, Minnesota, Estados Unidos, 55337
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, Estados Unidos, 55337
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, Estados Unidos, 55008
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, Estados Unidos, 55433
        • Mercy Hospital
      • Edina, Minnesota, Estados Unidos, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Estados Unidos, 55432
        • Unity Hospital
      • Maple Grove, Minnesota, Estados Unidos, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, Estados Unidos, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Estados Unidos, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Estados Unidos, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Estados Unidos, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Estados Unidos, 55454
        • Health Partners Inc
      • Monticello, Minnesota, Estados Unidos, 55362
        • Monticello Cancer Center
      • New Ulm, Minnesota, Estados Unidos, 56073
        • New Ulm Medical Center
      • Princeton, Minnesota, Estados Unidos, 55371
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, Estados Unidos, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic in Rochester
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Estados Unidos, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Estados Unidos, 55102
        • United Hospital
      • Shakopee, Minnesota, Estados Unidos, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Estados Unidos, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Estados Unidos, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Estados Unidos, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Estados Unidos, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, Estados Unidos, 55092
        • Fairview Lakes Medical Center
    • Missouri
      • Ballwin, Missouri, Estados Unidos, 63011
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, Estados Unidos, 65613
        • Central Care Cancer Center - Bolivar
      • City of Saint Peters, Missouri, Estados Unidos, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Creve Coeur, Missouri, Estados Unidos, 63141
        • Siteman Cancer Center at West County Hospital
      • Joplin, Missouri, Estados Unidos, 64804
        • Freeman Health System
      • Joplin, Missouri, Estados Unidos, 64804
        • Mercy Hospital Joplin
      • Rolla, Missouri, Estados Unidos, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Estados Unidos, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Estados Unidos, 64506
        • Heartland Regional Medical Center
      • Springfield, Missouri, Estados Unidos, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Estados Unidos, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Estados Unidos, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, Estados Unidos, 63136
        • Siteman Cancer Center at Christian Hospital
      • St Louis, Missouri, Estados Unidos, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Estados Unidos, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, Estados Unidos, 63128
        • Mercy Hospital South
      • Washington, Missouri, Estados Unidos, 63090
        • Mercy Hospital Washington
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68114
        • Nebraska Methodist Hospital
    • New Jersey
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Hackensack University Medical Center
    • New York
      • Buffalo, New York, Estados Unidos, 14263
        • Roswell Park Cancer Institute
      • Lake Success, New York, Estados Unidos, 11042
        • Northwell Health/Center for Advanced Medicine
      • New York, New York, Estados Unidos, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Estados Unidos, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, Estados Unidos, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, Estados Unidos, 28210
        • Atrium Health Pineville/LCI-Pineville
      • Durham, North Carolina, Estados Unidos, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Ohio State University Comprehensive Cancer Center
    • Oklahoma
      • Lawton, Oklahoma, Estados Unidos, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, Estados Unidos, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Monroeville, Pennsylvania, Estados Unidos, 15146
        • UPMC Hillman Cancer Center - Monroeville
      • Philadelphia, Pennsylvania, Estados Unidos, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • UPMC Hillman Cancer Center
      • Pittsburgh, Pennsylvania, Estados Unidos, 15215
        • UPMC-Saint Margaret
      • Williamsport, Pennsylvania, Estados Unidos, 17701
        • UPMC Susquehanna
      • Williamsport, Pennsylvania, Estados Unidos, 17754
        • Divine Providence Hospital
    • Rhode Island
      • Westerly, Rhode Island, Estados Unidos, 02891
        • Smilow Cancer Hospital Care Center - Westerly
    • South Carolina
      • Gaffney, South Carolina, Estados Unidos, 29341
        • Gibbs Cancer Center-Gaffney
      • Greer, South Carolina, Estados Unidos, 29651
        • Gibbs Cancer Center-Pelham
      • Spartanburg, South Carolina, Estados Unidos, 29303
        • Spartanburg Medical Center
      • Spartanburg, South Carolina, Estados Unidos, 29307
        • Spartanburg Medical Center - Mary Black Campus
      • Spartanburg, South Carolina, Estados Unidos, 29303
        • North Grove Medical Park
      • Union, South Carolina, Estados Unidos, 29379
        • SMC Center for Hematology Oncology Union
    • Tennessee
      • Franklin, Tennessee, Estados Unidos, 37067
        • Vanderbilt-Ingram Cancer Center Cool Springs
      • Nashville, Tennessee, Estados Unidos, 37232
        • Vanderbilt University/Ingram Cancer Center
      • Nashville, Tennessee, Estados Unidos, 37204
        • Vanderbilt Breast Center at One Hundred Oaks
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, Estados Unidos, 84106
        • University of Utah Sugarhouse Health Center
    • Virginia
      • Richmond, Virginia, Estados Unidos, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Seattle, Washington, Estados Unidos, 98195
        • University of Washington Medical Center - Montlake
      • Seattle, Washington, Estados Unidos, 98109
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Eau Claire, Wisconsin, Estados Unidos, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Marshfield, Wisconsin, Estados Unidos, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin
      • Minocqua, Wisconsin, Estados Unidos, 54548
        • Marshfield Medical Center - Minocqua
      • New Richmond, Wisconsin, Estados Unidos, 54017
        • Cancer Center of Western Wisconsin
      • 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
  • Guam
      • Tamuning, Guam, 96913
        • FHP Health Center-Guam

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

Criterio de elegibilidad

Los principales requisitos que deben cumplir las personas que quieran participar en un estudio clínico o las características que deben tener. Los criterios de elegibilidad consisten en criterios de inclusión (que se requieren para que una persona participe en el estudio) y criterios de exclusión (que impiden que una persona participe). Los tipos de criterios de elegibilidad incluyen si un estudio acepta voluntarios sanos, tiene requisitos de edad o grupo de edad, o está limitado por sexo.

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Histologically confirmed cutaneous or visceral angiosarcoma, where curative treatment is either not possible or curative modality therapy is declined by the subject. Note: If a subject declines curative modality therapy, the reason must be documented (e.g. excessive morbidity to necessary surgery)

    • Note: Radiation induced angiosarcomas are permitted

      • All local diagnostic slides AND 5 x 4-6 micron unstained slides from diagnostic tumor tissue should be available for retrospective central pathology review

  • Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per RECIST v1.1, clinical lesions will only be considered measurable when they are superficial and >= 10 mm diameter as assessed using calipers or ruler (e.g. skin nodules). For the case of skin lesions, documentation by color photography including a ruler to estimate the size of the lesion is required. When lesions can be evaluated by both clinical exam and imagining, imaging evaluation should be undertaken since it is more objective and may also be reviewed at the end of the study. The same method of measurement should be used throughout the study, preferably performed by the same investigator. Areas previously radiated must have demonstrated disease progression at some point over the past 6 months and growth must be subsequent to the last line of anti-cancer directed therapy (e.g. chemotherapy, radiation therapy, surgery)

  • 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 pregnancy test done =< 3 days prior to registration is required

  • Age >= 18 years

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  • Prior Treatment

    • Patient must have completed all prior cancer directed therapies (including investigational) >= 7 days prior to cycle 1 day 1

      • Exception: prostate patients who are allowed to concurrently receive androgen suppression therapy
      • Note: Radiation therapy must be completed >= 7 days of day 1 of study treatment, and must not be expected to significantly impact blood count recovery

    • There is no limit to overall number of prior lines of therapy

    • No prior PD-1 inhibitor or PD-L1 inhibitor therapy is permitted

    • No prior administration of VEGF TKI therapy is permitted

    • Recovery to baseline or' =< grade 1 CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically non-significant and/or stable on supportive therapy, with the exception of fatigue (which should be =< grade 2) or alopecia. Note: Patients should be expected to have experienced any nadir and have adequate blood count recovery prior to cycle 1 day 1

  • Taxane Naive Patients Only: No prior exposure to taxane therapy of any duration for angiosarcoma

  • Taxane Pre-treated Patients Only (Effective 10/28/2021, new patient accrual to Arm 3 was permanently closed): Prior taxane therapy is allowed at any point prior to registration as long as prior treatment eligibility criteria are met prior to cycle 1 day 1

  • No major surgery (except the diagnostic biopsy) =< 28 days of study registration. Procedures such as thoracentesis, paracentesis, percutaneous biopsy, Lasik eye surgery are not considered major surgery. Subjects with clinically relevant ongoing complications from prior surgery are not eligible

  • Absolute neutrophil count (ANC) >= 1,500/mm^3

  • Platelet count >= 100,000/mm^3

  • Hemoglobin >= 9.0 g/dL

  • Calculated (Calc.) creatinine clearance >= 30 mL/min (per Cockcroft-Gault)

  • Total bilirubin =< 1.5 x upper limit of normal (ULN)

    • For patients with documented/suspected Gilbert's disease, bilirubin =< 3 x ULN

  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)

    • For patients with significant hepatic metastases, ALT and AST =< 5 x ULN. No clinically active or chronic liver disease resulting in moderate/severe hepatic impairment (Child-Pugh class B or C), ascites, coagulopathy or bleeding due to liver dysfunction

  • Urine protein:creatinine (UPC) ratio < 1 or urine protein =< 1+ (Only for Arm 3 Taxane pre-treated and crossover patients)

  • No uncontrolled central nervous system (CNS) metastases. Patients with history of CNS metastasis will be allowed as long as the metastatic sites were adequately treated as demonstrated by clinical and radiographic improvement, and the patient has recovered from the intervention (no residual adverse events > CTCAE grade 1), and the patient has remained without recurrence of new or worsening CNS symptoms for a period of 28 days prior to registration. Treated CNS metastasis (mets) should have no ongoing requirement for steroids, and no evidence of hemorrhage after treatment for at least 28 days prior to registration

  • No uncontrolled intercurrent illness that would put the patient at undue risk by participation in the study, in the opinion of the investigator

  • No history of syncope of cardiovascular etiology, uncontrolled cardiac arrhythmia, history of Mobitz II second degree or third degree heart block without a permanent pacemaker in place, myocardial ischemia or infarction, severe or unstable angina, New York Heart Association (NYHA) class II to IV heart failure, or stroke/transient ischemic attack (TIA) within the past 3 months

  • No thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 1 month before randomization. Subjects with a diagnosis of incidental, subsegmental pulmonary embolism (PE) or deep vein thrombosis (DVT) within 6 months are allowed if stable, asymptomatic, and treated with low molecular weight heparin (LMWH) for at least 2 weeks before first dose. Iatrogenic arterial embolization procedures such as tumor arterial embolization or splenic artery embolization are allowed

  • Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). A brief 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 contact allergen) is permitted

  • Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)

  • Active autoimmune disease requiring systemic treatment (i.e. disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. These include but are not limited to patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and 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

    • Note: Patients are permitted to enroll if they have vitiligo; type I diabetes mellitus; hypothyroidism, pituitary or adrenal insufficiency requiring only hormone replacement; psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)

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

  • No planned palliative procedures for alleviation of pain such as radiation therapy or surgery

  • No untreated or impending spinal cord compression or evidence of spinal metastases with a risk of impending fracture or spinal cord compression

  • No known or suspected contraindications or hypersensitivity to paclitaxel, cabozantinib or nivolumab or to any of the excipients

  • Disorders associated with a high risk of perforation or fistula formation: active inflammatory bowel disease, active diverticulitis, active cholecystitis, active symptomatic cholangitis or active appendicitis, active acute pancreatitis or active acute obstruction of the pancreatic or biliary duct, or active gastric outlet obstruction; abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before randomization. Note: Complete healing of an intra-abdominal abscess must be confirmed before randomization

  • No clinically significant hematuria, hematemesis, or hemoptysis, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 3 months before randomization

  • No lesions invading major pulmonary blood vessels

  • No other clinically significant disorders: uncompensated/symptomatic hypothyroidism; requirements for hemodialysis or peritoneal dialysis; history of solid organ transplantation

  • Serious non-healing wounds unrelated to cancer are excluded

    • Note: Wounds that are cutaneous angiosarcoma are allowed

  • Chronic concomitant treatment with strong inhibitors and inducers of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors and inducers must discontinue the drug 7 days and 14 days, respectively prior to registration on the study

  • Taxane Naive Patients Only: No clinically significant neuropathy (grade >= 2 per NCI CTCAE v5.0)

  • Taxane Pre-treated only (Effective 10/28/2021, new patient accrual to Arm 3 was permanently closed):

    • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before first dose. Subjects with a diagnosis of DVT within 6 months are allowed if stable and treated with LMWH for at least 2 weeks before first dose
    • No history of clinically significant coagulopathy
    • No uncontrolled hypertension, defined as systolic blood pressure of > 140 mmHg or diastolic pressure > 90 mmHg on anti-hypertensive medications
    • No known or suspected gastrointestinal disorder affecting absorption of oral medications (for patients getting cabozantinib)

  • No clinical, laboratory or radiographic evidence of an active bacterial, fungal, or viral infection requiring treatment at the time of registration. No concurrent use of parenteral (IV) antibiotics is permitted. Oral antibiotics administered for a defined course with expectation of resolution of infection are permitted at the discretion of the investigator

  • No use of ongoing systemic steroid therapy within 7 days prior to study registration. Dose equivalence of prednisone 10mg daily or less is permitted

  • Taxane Pre-treated only:

    • No current use of aspirin (> 81 mg/day), or any other antiplatelet agents
    • Concomitant anticoagulation with oral anticoagulants (e.g., warfarin, direct thrombin inhibitors, and factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel) is not permitted. Low-dose (prophylactic) low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects with no known brain metastases, no clinically significant hemorrhage, or no complications from a thromboembolic event on the anticoagulation regimen, and who have been on a stable dose of LMWH for at least 2 weeks before first dose

  • Patients must be able to speak and comprehend English or Spanish in order to complete the mandatory patient-completed measures

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): 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 pregnancy test done =< 3 days prior to re-registration is required

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Age >= 18 years

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): ECOG performance status 0-1

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Prior Treatment

    • Patient must have completed all prior treatments (including investigational Arm 2 paclitaxel) >= 28 days prior to cycle 1 day 1

      • Exception: prostate patients who are allowed to concurrently receive androgen suppression therapy
      • Note: Re-registration is only permitted after progression on Arm 2

    • No prior PD-1 inhibitor or PD-L1 inhibitor therapy is permitted

    • Recovery to baseline, or =< grade 1 CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically non-significant and/or stable on supportive therapy, with the exception of fatigue (which should be =< grade 2) or alopecia. Note: Patients should be expected to have experienced any nadir and have adequate blood count recovery prior to cycle 1 day 1

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No major surgery (except the diagnostic biopsy) =< 28 days of study re-registration. Procedures such as thoracentesis, paracentesis, percutaneous biopsy, Lasik eye surgery are not considered major surgery. Subjects with clinically relevant ongoing complications from prior surgery are not eligible

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Absolute neutrophil count (ANC) >= 1,500/mm^3

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Platelet count >= 100,000/mm^3

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Hemoglobin >= 9.0 g/dL

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Calc. creatinine clearance >= 30 mL/min (per Cockcroft-Gault)

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Total bilirubin =< 1.5 x upper limit of normal (ULN)

    • For patients with documented/suspected Gilbert's disease, bilirubin =< 3 x ULN

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): AST/ALT =< 2.5 x upper limit of normal (ULN)

    • For patients with significant hepatic metastases, ALT and AST =< 5 x ULN. No clinically active or chronic liver disease resulting in moderate/severe hepatic impairment (Child-Pugh class B or C), ascites, coagulopathy or bleeding due to liver dysfunction

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): UPC ratio < 1 or urine protein =< 1+

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No uncontrolled CNS metastases. Patients with history of CNS metastasis will be allowed as long as the metastatic sites were adequately treated as demonstrated by clinical and radiographic improvement, and the patient has recovered from the intervention (no residual adverse events > CTCAE grade 1), and the patient has remained without recurrence of new or worsening CNS symptoms for a period of 28 days prior to registration. Treated CNS mets should have no ongoing requirement for steroids, and no evidence of hemorrhage after treatment for at least 28 days prior to registration

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No uncontrolled intercurrent illness that would put the patient at undue risk by participation in the study, in the opinion of the investigator

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No history of syncope of cardiovascular etiology, uncontrolled cardiac arrhythmia, History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place, myocardial ischemia or infarction, severe or unstable angina, New York Heart Association (NYHA) class II to IV heart failure, or stroke/transient ischemic attack (TIA) within the past 3 months

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 1 month before randomization. Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if stable, asymptomatic, and treated with LMWH for at least 2 weeks before first dose. Iatrogenic arterial embolization procedures such as tumor arterial embolization or splenic artery embolization are allowed

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). A brief 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 contact allergen) is permitted

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): Active autoimmune disease requiring systemic treatment (i.e. disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. These include but are not limited to patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and 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

    • Note: Patients are permitted to enroll if they have vitiligo; type I diabetes mellitus; hypothyroidism, pituitary or adrenal insufficiency requiring only hormone replacement; psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No planned palliative procedures for alleviation of pain such as radiation therapy or surgery

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No untreated or impending spinal cord compression or evidence of spinal metastases with a risk of impending fracture or spinal cord compression

  • Re-Registration Eligibility Criteria (upon progression on Arm 2 only): No known or suspected contraindications or hypersensitivity to cabozantinib or nivolumab or to any of the exc

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

Grupo de participantes/brazo

Un grupo o subgrupo de participantes en un ensayo clínico que recibe una intervención/tratamiento específico, o ninguna intervención, según el protocolo del ensayo.
Intervención / Tratamiento

Intervención / Tratamiento

Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.
Experimental: Arm I (nivolumab, paclitaxel)

Patients receive nivolumab IV over 30 minutes on day 1 and paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
Droga: Paclitaxel

Given IV

Otros nombres:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Otro: Quality-of-Life Assessment

Ancillary studies

Otros nombres:
  • Evaluación de la calidad de vida
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
Otro: Questionnaire Administration

Ancillary studies

Procedimiento: Biospecimen Collection

Undergo collection of blood

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
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: FDG-Positron Emission Tomography

Undergo FDG-PET

Otros nombres:
  • FDG
  • PET-FDG
  • Imágenes FDG-PET
Procedimiento: Computed Tomography

Undergo CT, spiral CT

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 II (paclitaxel)

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Cycles repeat every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
Droga: Paclitaxel

Given IV

Otros nombres:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Otro: Quality-of-Life Assessment

Ancillary studies

Otros nombres:
  • Evaluación de la calidad de vida
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
Otro: Questionnaire Administration

Ancillary studies

Procedimiento: Biospecimen Collection

Undergo collection of blood

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
Procedimiento: FDG-Positron Emission Tomography

Undergo FDG-PET

Otros nombres:
  • FDG
  • PET-FDG
  • Imágenes FDG-PET
Procedimiento: Computed Tomography

Undergo CT, spiral CT

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 III (nivolumab, cabozantinib S-malate)

Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib S-malate PO daily. Cycles repeat every 4 weeks for up to 2 years (24 months) for patients who achieve CR, PR or SD on immunotherapy/nivolumab, or in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood at baseline and on study, CT scan, spiral CT, or MRI, or FDG-PET scan throughout the trial.
Otro: Quality-of-Life Assessment

Ancillary studies

Otros nombres:
  • Evaluación de la calidad de vida
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
Otro: Questionnaire Administration

Ancillary studies

Droga: Cabozantinib S-malate

Given PO

Otros nombres:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
Procedimiento: Biospecimen Collection

Undergo collection of blood

Otros nombres:
  • Recolección de muestras biológicas
  • Muestra biológica recolectada
  • Coleccion de especimenes
  • Recolección de muestras
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: FDG-Positron Emission Tomography

Undergo FDG-PET

Otros nombres:
  • FDG
  • PET-FDG
  • Imágenes FDG-PET
Procedimiento: Computed Tomography

Undergo CT, spiral CT

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

Medidas de resultado primarias

En el protocolo de un estudio clínico, la medida de resultado planificada que es la más importante para evaluar el efecto de una intervención/tratamiento. La mayoría de los estudios clínicos tienen una medida de resultado primaria, pero algunos tienen más de una.
Medida de resultado
Medida Descripción
Periodo de tiempo
Progression Free Survival (PFS) in Taxane Naive Patients With Angiosarcoma
Periodo de tiempo: 21 months

Will compare the PFS in taxane naive angiosarcoma patients receiving either (1) paclitaxel + nivolumab compared to (2) paclitaxel alone. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions compared to the nadir (smallest) sum of target lesions, any new lesions, or unequivocal progression of existing non-target lesions.
21 months
Overall Response Rate (ORR) in Angiosarcoma Patients Who Have Had Prior Taxane
Periodo de tiempo: 1.5 years

ORR defined as count of participants that reported a confirmed best response of partial response (PR) or complete response (CR). Evaluation of disease response determination will be defined based on RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Each target lymph node must have reduction in short axis to <1.0 cm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
1.5 years

Medidas de resultado secundarias

Medidas de resultado secundarias

En el protocolo de un estudio clínico, una medida de resultado planificada que no es tan importante como la medida de resultado primaria para evaluar el efecto de una intervención pero que sigue siendo de interés. La mayoría de los estudios clínicos tienen más de una medida de resultado secundaria.
Medida de resultado
Medida Descripción
Periodo de tiempo
ORR in the Nivolumab + Paclitaxel
Periodo de tiempo: Up to 3 years

Will be estimated by dividing the number of evaluable patients that achieve a confirmed response by the total number of evaluable patients in the nivolumab + paclitaxel combination arm. Additionally a 95% confidence interval will be constructed utilizing properties of the binomial distribution.
Up to 3 years
Overall Survival in Each of the 2 Combination Arms
Periodo de tiempo: From study enrollment until death due to any cause, assessed up to 3 years

Will be evaluated using the Kaplan-Meier method in order to determine the median survival rate. This median survival rate will be calculated for each of the 2 combination arms (i.e. nivolumab + paclitaxel and nivolumab + cabozantinib).
From study enrollment until death due to any cause, assessed up to 3 years
PFS Rate
Periodo de tiempo: At 6 months

A patient will be declared an event for this endpoint if they had documented progression (or death) prior to, or at, their 6 month evaluation. This endpoint will be applied to the patients on the nivolumab + cabozantinib combination arm.
At 6 months
Incidence of Adverse Events
Periodo de tiempo: Up to 3 years

Maximum grade adverse events will be summarized by treatment arm in a tabular setting. This will be done both with and without regard to the assigned attribution of each adverse event.
Up to 3 years
Patient-reported Outcomes (PRO)
Periodo de tiempo: Up to 3 years

Will be assessed via PRO-Common Terminology Criteria for Adverse Events (CTCAE). In order to evaluate this endpoint we will calculate the proportion of patients that report a grade 3+ event along with a 95% confidence interval based on the properties of the binomial distribution. Any other analyses with these data will be done in an exploratory and hypothesis generating manner.
Up to 3 years

Colaboradores e Investigadores

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

Patrocinador

Patrocinador

La organización o persona que inicia el estudio y que tiene autoridad y control sobre el estudio.
National Cancer Institute (NCI)

Investigadores

Investigadores

Un investigador involucrado en un estudio clínico. Los términos relacionados incluyen investigador principal del sitio, subinvestigador del sitio, presidente del estudio, director del estudio e investigador principal del estudio.
  • Investigador principal: Juneko E Grilley-Olson, 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)

Inicio del estudio

La fecha real en la que el primer participante se inscribió en un estudio clínico. La fecha de inicio "anticipada" del estudio es la fecha que los investigadores creen que será la fecha de inicio del estudio.
4 de noviembre de 2020

Finalización primaria (Actual)

Finalización primaria

La fecha en la que el último participante en un estudio clínico fue examinado o recibió una intervención para recopilar datos finales para la medida de resultado primaria. Si el estudio clínico terminó de acuerdo con el protocolo o se terminó, no afecta esta fecha. Para estudios clínicos con más de una medida de resultado primaria con diferentes fechas de finalización, este término se refiere a la fecha en que se completa la recopilación de datos para todas las medidas de resultado primarias. La fecha de finalización principal "anticipada" es la fecha que los investigadores creen que será la fecha de finalización principal del estudio.
30 de marzo de 2025

Finalización del estudio (Estimado)

Finalización del estudio

La fecha en la que el último participante en un estudio clínico fue examinado o recibió una intervención/tratamiento para recopilar los datos finales de las medidas de resultado primarias, las medidas de resultado secundarias y los eventos adversos (es decir, la última visita del último participante). La fecha de finalización "anticipada" del estudio es la fecha que los investigadores creen que será la fecha de finalización del estudio.
21 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

Enviado por primera vez

La fecha en la que el patrocinador o investigador del estudio envió por primera vez un registro del estudio a ClinicalTrials.gov. Por lo general, hay un retraso de unos días entre la primera fecha de envío y la disponibilidad del registro en ClinicalTrials.gov (la primera fecha publicada).
8 de abril de 2020

Primero enviado que cumplió con los criterios de control de calidad

Primero enviado que cumplió con los criterios de control de calidad

La fecha en la que el patrocinador del estudio o el investigador envía por primera vez un registro del estudio que es consistente con los criterios de revisión de control de calidad (QC) de la Biblioteca Nacional de Medicina (NLM). Es posible que el patrocinador o el investigador deba revisar y enviar un registro de estudio una o más veces antes de que se cumplan los criterios de revisión de control de calidad de la NLM. Es responsabilidad del patrocinador o investigador asegurarse de que el registro del estudio sea coherente con los criterios de revisión de control de calidad de la NLM.
8 de abril de 2020

Publicado por primera vez (Actual)

Publicado por primera vez

La fecha en la que el registro del estudio estuvo disponible por primera vez en ClinicalTrials.gov después de que concluyó la revisión de control de calidad (QC) de la Biblioteca Nacional de Medicina (NLM). Por lo general, hay una demora de unos días entre la fecha en que el patrocinador del estudio o el investigador envió el registro del estudio y la primera fecha publicada.
9 de abril de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

Última actualización publicada

La fecha más reciente en la que se pusieron a disposición los cambios en un registro del estudio en ClinicalTrials.gov. Puede haber una demora entre el momento en que el patrocinador o el investigador del estudio envió los cambios a ClinicalTrials.gov (la fecha de envío de la última actualización) y la fecha de publicación de la última actualización.
13 de noviembre de 2026

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

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

La fecha más reciente en la que el patrocinador del estudio o el investigador presentó cambios en un registro del estudio que son consistentes con los criterios de revisión de control de calidad (QC) de la Biblioteca Nacional de Medicina (NLM). Es responsabilidad del patrocinador o investigador asegurarse de que el registro del estudio sea coherente con los criterios de revisión de control de calidad de la NLM.
11 de noviembre de 2026

Última verificación

Última verificación

La fecha más reciente en la que el patrocinador o investigador del estudio confirmó que la información sobre un estudio clínico en ClinicalTrials.gov es precisa y actual. Si un estudio con un estado de reclutamiento de reclutamiento; aún no está reclutando; o activo, no se ha confirmado el reclutamiento en los últimos 2 años, el estado de reclutamiento del estudio se muestra como desconocido.
1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

Otros números de identificación del estudio

Identificadores o números de identificación distintos del número NCT que el patrocinador del estudio, los financiadores u otros asignan a un estudio clínico. Estos números pueden incluir identificadores únicos de otros registros de ensayos y números de subvención de los Institutos Nacionales de Salud.
  • NCI-2020-02153
  • U10CA180821 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2020-02153 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • A091902 (Otro identificador: CTEP)
  • A091902 (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

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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