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Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

Estado del programa

Activo, no recluta

Fase

Fase 1

Inmunoterapia previa permitida

Sí

Ensayo dirigido por el CRC

Sí

Drogas

Atezolizumab, Cabozantinib

Etiquetas

MSS/ MMRp

Ubicación	Situación
Estados Unidos
Exelixis Clinical Site #53 Gilbert, Arizona 85234	Activo, no recluta
Exelixis Clinical Site #18 Phoenix, Arizona 85054	Activo, no recluta
Exelixis Clinical Site #1 Duarte, California 91010	Activo, no recluta
Exelixis Clinical Site #20 La Jolla, California 92090	Activo, no recluta
Exelixis Clinical Site #46 Los Angeles, California 90025	Activo, no recluta
Exelixis Clinical Site #51 Newport Beach, California 92663	Activo, no recluta
Exelixis Clinical Site #62 Santa Monica, California 90404	Activo, no recluta
Exelixis Clinical Site #21 Stanford, California 94305	Activo, no recluta
Exelixis Clinical Site #34 Denver, Colorado 80218	Activo, no recluta
Exelixis Clinical Site #50 Denver, Colorado 80218	Activo, no recluta
Exelixis Clinical Site #42 New Haven, Connecticut 06511	Activo, no recluta
Exelixis Clinical Site #48 Washington, Distrito de Columbia 20007	Activo, no recluta
Exelixis Clinical Site #16 Jacksonville, Florida 32224	Activo, no recluta
Exelixis Clinical Site #76 Tampa, Florida 33612	Activo, no recluta
Exelixis Clinical Site #60 Atlanta, Georgia 30318	Activo, no recluta
Exelixis Clinical Site #79 Atlanta, Georgia 30341	Activo, no recluta
Exelixis Clinical Site #32 Harvey, Illinois 60426	Activo, no recluta
Exelixis Clinical Site #23 Fairway, Kansas 66205	Activo, no recluta
Exelixis Clinical Site #57 Lexington, Kentucky 40536	Activo, no recluta
Exelixis Clinical Site #24 New Orleans, Louisiana 70112	Activo, no recluta
Exelixis Clinical Site #10 Boston, Massachusetts 02215	Activo, no recluta
Exelixis Clinical Site #3 Detroit, Michigan 48201	Activo, no recluta
Exelixis Clinical Site #17 Rochester, Minnesota 55905	Activo, no recluta
Exelixis Clinical Site #65 Bolivar, Missouri 65613	Activo, no recluta
Exelixis Clinical Site #43 Kansas City, Missouri 64111	Activo, no recluta
Exelixis Clinical Site #35 Omaha, Nebraska 68130	Activo, no recluta
Exelixis Clinical Site #59 Omaha, Nebraska 68130	Activo, no recluta
Exelixis Clinical Site #61 Las Vegas, Nevada 89169	Activo, no recluta
Exelixis Clinical Site #38 Camden, Nueva Jersey 08103	Activo, no recluta
Exelixis Clinical Site #27 East Brunswick, New Jersey 08816	Activo, no recluta
Exelixis Clinical Site #31 New Brunswick, Nueva Jersey 08903	Activo, no recluta
Exelixis Clinical Site #37 Bronx, Nueva York 10461	Activo, no recluta
Exelixis Clinical Site #40 East Setauket, New York 11733	Activo, no recluta
Exelixis Clinical Site #11 Nueva York, Nueva York 10029	Activo, no recluta
Exelixis Clinical Site #67 Cleveland, Ohio 44195	Activo, no recluta
Exelixis Clinical Site #49 Columbus, Ohio 43210	Activo, no recluta
Exelixis Clinical Site #64 Kettering, Ohio 45409	Activo, no recluta
Exelixis Clinical Site #71 Oklahoma City, Oklahoma 73104	Activo, no recluta
Exelixis Clinical Site #6 Oklahoma City, Oklahoma 73120	Activo, no recluta
Exelixis Clinical Site #102 Portland, Oregón 97213	Activo, no recluta
Exelixis Clinical Site #45 Portland, Oregon 97239	Activo, no recluta
Exelixis Clinical Site #41 Bethlehem, Pennsylvania 18015	Activo, no recluta
Exelixis Clinical Site #15 Filadelfia, Pensilvania 19107	Activo, no recluta
Exelixis Clinical Site #55 Philadelphia, Pennsylvania 19111	Activo, no recluta
Exelixis Clinical Site #66 Pittsburgh, Pensilvania 15232	Activo, no recluta
Exelixis Clinical Site #95 Charleston, South Carolina 29414	Activo, no recluta
Exelixis Clinical Site #13 Dallas, Texas 75246	Activo, no recluta
Exelixis Clinical Site #26 Dallas, Texas 75390	Activo, no recluta
Exelixis Clinical Site #114 Fort Worth, Texas 76104	Activo, no recluta
Exelixis Clinical Site #29 Houston, Texas 77030	Activo, no recluta
Exelixis Clinical Site #39 Houston, Texas 77030	Activo, no recluta
Exelixis Clinical Site #44 Houston, Texas 77030	Activo, no recluta
Exelixis Clinical Site #33 Lubbock, Texas 79410	Activo, no recluta
Exelixis Clinical Site #63 San Antonio, Texas 78229	Activo, no recluta
Exelixis Clinical Site #2 Salt Lake City, Utah 84112	Activo, no recluta
Exelixis Clinical Site #30 Blacksburg, Virginia 24060	Activo, no recluta
Exelixis Clinical Site #14 Charlottesville, Virginia 22908	Activo, no recluta
Australia
Exelixis Clinical Site #98 Albury, New South Wales 2640	Activo, no recluta
Exelixis Clinical Site #101 Camperdown, New South Wales 2050	Activo, no recluta
Exelixis Clinical Site #115 Gosford, New South Wales 2250	Activo, no recluta
Exelixis Clinical Site #112 North Ryde, New South Wales 2109	Activo, no recluta
Exelixis Clinical Site #123 Randwick, Nueva Gales del Sur 2031	Activo, no recluta
Exelixis Clinical Site #99 St Albans, Victoria 3021	Activo, no recluta
Bélgica
Exelixis Clinical Site #52 Gante 9000	Activo, no recluta
Exelixis Clinical Site #54 Lovaina 3000	Activo, no recluta
Francia
Exelixis Clinical Site #88 La Roche-sur-Yon, Cedex 9 85925	Activo, no recluta
Exelixis Clinical Site #8 Villejuif, Cedex 94805	Activo, no recluta
Exelixis Clinical Site #92 Burdeos 33076	Activo, no recluta
Exelixis Clinical Site #93 Brest 29229	Activo, no recluta
Exelixis Clinical Site #87 CAEN Cedex 05 14076	Activo, no recluta
Exelixis Clinical Site #69 Le Mans 72000	Activo, no recluta
Exelixis Clinical Site #97 Lille 59000	Activo, no recluta
Exelixis Clinical Site #89 Lyon Cedex 08 69373	Activo, no recluta
Exelixis Clinical Site #109 Marseille 13273	Activo, no recluta
Exelixis Clinical Site #104 Nice Cedex 02 06189	Activo, no recluta
Exelixis Clinical Site #80 Nîmes Cedex 09 30029	Activo, no recluta
Exelixis Clinical Site #78 Paris 75005	Activo, no recluta
Exelixis Clinical Site #7 París 75010	Activo, no recluta
Exelixis Clinical Site #68 Paris 75013	Activo, no recluta
Exelixis Clinical Site #72 París 75015	Activo, no recluta
Exelixis Clinical Site #82 Saint-Grégoire 35760	Activo, no recluta
Exelixis Clinical Site #119 Strasbourg 67000	Activo, no recluta
Exelixis Clinical Site #107 Suresnes 92150	Activo, no recluta
Exelixis Clinical Site #105 Vandoeuvre les nancy 54519	Activo, no recluta
Alemania
Exelixis Clinical Site #56 Düsseldorf, Nordrhein-Westfalen 40225	Activo, no recluta
Exelixis Clinical Site #36 Tubinga 72076	Activo, no recluta
Italia
Exelixis Clinical Site #84 Meldola, FC 47014	Activo, no recluta
Exelixis Clinical Site #47 Rozzano, Milán 20089	Activo, no recluta
Exelixis Clinical Site #108 Milán 20132	Activo, no recluta
Exelixis Clinical Site #103 Milano 20133	Activo, no recluta
Exelixis Clinical Site #25 Milano 20133	Activo, no recluta
Exelixis Clinical Site #4 Milano 20133	Activo, no recluta
Exelixis Clinical Site #85 Nápoles 80131	Activo, no recluta
Exelixis Clinical Site #121 Pavia 27100	Activo, no recluta
Exelixis Clinical Site #110 Roma 00168	Activo, no recluta
Países Bajos
Exelixis Clinical Site #12 Nijmegen, Gelderland 6525 GA	Activo, no recluta
España
Exelixis Clinical Site #74 Santiago De Compostela, A Coruña 15706	Activo, no recluta
Exelixis Clinical Site #91 Elche, Alicante 03203	Activo, no recluta
Exelixis Clinical Site #94 Oviedo, Asturias 33011	Activo, no recluta
Exelixis Clinical Site #70 Palma De Mallorca, Baleares 07120 / 07010	Activo, no recluta
Exelixis Clinical Site #113 Badalona, Barcelona 08916	Activo, no recluta
Exelixis Clinical Site #116 Sabadell, Barcelona 08208	Activo, no recluta
Exelixis Clinical Site #96 Jeréz De La Frontera, Cádiz 11407	Activo, no recluta
Exelixis Clinical Site #90 Pamplona, Navarra 31008	Activo, no recluta
Exelixis Clinical Site #117 La Laguna, Santa Cruz De Tenerife 38320	Activo, no recluta
Exelixis Clinical Site #75 Barcelona 08003	Activo, no recluta
Exelixis Clinical Site #58 Barcelona 08022	Activo, no recluta
Exelixis Clinical Site #83 Barcelona 08023	Activo, no recluta
Exelixis Clinical Site #86 Barcelona 08025	Activo, no recluta
Exelixis Clinical Site #28 Barcelona 08035	Activo, no recluta
Exelixis Clinical Site #9 Barcelona 08035	Activo, no recluta
Exelixis Clinical Site #73 Barcelona 08036	Activo, no recluta
Exelixis Clinical Site #118 Girona 17007	Activo, no recluta
Exelixis Clinical Site #77 Madrid 28034	Activo, no recluta
Exelixis Clinical Site #106 Madrid 28040	Activo, no recluta
Exelixis Clinical Site #111 Madrid 28040	Activo, no recluta
Exelixis Clinical Site #22 Madrid 28041	Activo, no recluta
Exelixis Clinical Site #5 Madrid 28041	Activo, no recluta
Exelixis Clinical Site #81 Madrid 28046	Activo, no recluta
Exelixis Clinical Site #100 Málaga 29010	Activo, no recluta
Reino Unido
Exelixis Clinical Site #122 Middlesex, England HA6 2RN	Activo, no recluta
Exelixis Clinical Site #120 Preston, England PR2 9HT	Activo, no recluta
Exelixis Clinical Site #124 Cardiff, Wales CF14 2TL	Activo, no recluta
Exelixis Clinical Site #19 London EC1M 6BQ	Activo, no recluta

Criterios de inclusión

Criterios de inclusión:

Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent:

Dose-Escalation Stage:

Subjects with UC (including renal pelvis, ureter, bladder, urethra) after prior platinum-based therapy, or
Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy

Expansion Stage:

Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H&N cancer, and DTC as outlined above)
Measurable disease per RECIST 1.1 as determined by the investigator.
Tumor tissue material available (archival or recent tumor biopsy)
Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
Age eighteen years or older on the day of consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Adequate organ and marrow function.
Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.
Female subjects of childbearing potential must not be pregnant at screening.

Criterios de exclusión

Criterios de exclusión:

Prior treatment with cabozantinib or immune checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts 5, 7, 9, 11, 17, 19 and 20. Other restrictions regarding prior therapy may apply.
Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks before first dose of study treatment.
Concomitant anticoagulation with oral anticoagulants.
Subject is receiving systemic steroid therapy (>10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.
Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).
Pregnant or lactating females.
Previously identified allergy or hypersensitivity to components of the study treatment formulations.
Diagnosis of another malignancy within 2 years before first dose of study treatment.

NCT ID

NCT03170960

Fecha en que se añadió el juicio

2017-05-31

Fecha de actualización

2023-07-27