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

Program Status

Active, not recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

Atezolizumab, Cabozantinib

Tags

MSS/ MMRp

Location	Location Status
United States
Exelixis Clinical Site #53 Gilbert, Arizona 85234	Active, not recruiting
Exelixis Clinical Site #18 Phoenix, Arizona 85054	Active, not recruiting
Exelixis Clinical Site #1 Duarte, California 91010	Active, not recruiting
Exelixis Clinical Site #20 La Jolla, California 92090	Active, not recruiting
Exelixis Clinical Site #46 Los Angeles, California 90025	Active, not recruiting
Exelixis Clinical Site #51 Newport Beach, California 92663	Active, not recruiting
Exelixis Clinical Site #62 Santa Monica, California 90404	Active, not recruiting
Exelixis Clinical Site #21 Stanford, California 94305	Active, not recruiting
Exelixis Clinical Site #34 Denver, Colorado 80218	Active, not recruiting
Exelixis Clinical Site #50 Denver, Colorado 80218	Active, not recruiting
Exelixis Clinical Site #42 New Haven, Connecticut 06511	Active, not recruiting
Exelixis Clinical Site #48 Washington, District of Columbia 20007	Active, not recruiting
Exelixis Clinical Site #16 Jacksonville, Florida 32224	Active, not recruiting
Exelixis Clinical Site #76 Tampa, Florida 33612	Active, not recruiting
Exelixis Clinical Site #60 Atlanta, Georgia 30318	Active, not recruiting
Exelixis Clinical Site #79 Atlanta, Georgia 30341	Active, not recruiting
Exelixis Clinical Site #32 Harvey, Illinois 60426	Active, not recruiting
Exelixis Clinical Site #23 Fairway, Kansas 66205	Active, not recruiting
Exelixis Clinical Site #57 Lexington, Kentucky 40536	Active, not recruiting
Exelixis Clinical Site #24 New Orleans, Louisiana 70112	Active, not recruiting
Exelixis Clinical Site #10 Boston, Massachusetts 02215	Active, not recruiting
Exelixis Clinical Site #3 Detroit, Michigan 48201	Active, not recruiting
Exelixis Clinical Site #17 Rochester, Minnesota 55905	Active, not recruiting
Exelixis Clinical Site #65 Bolivar, Missouri 65613	Active, not recruiting
Exelixis Clinical Site #43 Kansas City, Missouri 64111	Active, not recruiting
Exelixis Clinical Site #35 Omaha, Nebraska 68130	Active, not recruiting
Exelixis Clinical Site #59 Omaha, Nebraska 68130	Active, not recruiting
Exelixis Clinical Site #61 Las Vegas, Nevada 89169	Active, not recruiting
Exelixis Clinical Site #38 Camden, New Jersey 08103	Active, not recruiting
Exelixis Clinical Site #27 East Brunswick, New Jersey 08816	Active, not recruiting
Exelixis Clinical Site #31 New Brunswick, New Jersey 08903	Active, not recruiting
Exelixis Clinical Site #37 Bronx, New York 10461	Active, not recruiting
Exelixis Clinical Site #40 East Setauket, New York 11733	Active, not recruiting
Exelixis Clinical Site #11 New York, New York 10029	Active, not recruiting
Exelixis Clinical Site #67 Cleveland, Ohio 44195	Active, not recruiting
Exelixis Clinical Site #49 Columbus, Ohio 43210	Active, not recruiting
Exelixis Clinical Site #64 Kettering, Ohio 45409	Active, not recruiting
Exelixis Clinical Site #71 Oklahoma City, Oklahoma 73104	Active, not recruiting
Exelixis Clinical Site #6 Oklahoma City, Oklahoma 73120	Active, not recruiting
Exelixis Clinical Site #102 Portland, Oregon 97213	Active, not recruiting
Exelixis Clinical Site #45 Portland, Oregon 97239	Active, not recruiting
Exelixis Clinical Site #41 Bethlehem, Pennsylvania 18015	Active, not recruiting
Exelixis Clinical Site #15 Philadelphia, Pennsylvania 19107	Active, not recruiting
Exelixis Clinical Site #55 Philadelphia, Pennsylvania 19111	Active, not recruiting
Exelixis Clinical Site #66 Pittsburgh, Pennsylvania 15232	Active, not recruiting
Exelixis Clinical Site #95 Charleston, South Carolina 29414	Active, not recruiting
Exelixis Clinical Site #13 Dallas, Texas 75246	Active, not recruiting
Exelixis Clinical Site #26 Dallas, Texas 75390	Active, not recruiting
Exelixis Clinical Site #114 Fort Worth, Texas 76104	Active, not recruiting
Exelixis Clinical Site #29 Houston, Texas 77030	Active, not recruiting
Exelixis Clinical Site #39 Houston, Texas 77030	Active, not recruiting
Exelixis Clinical Site #44 Houston, Texas 77030	Active, not recruiting
Exelixis Clinical Site #33 Lubbock, Texas 79410	Active, not recruiting
Exelixis Clinical Site #63 San Antonio, Texas 78229	Active, not recruiting
Exelixis Clinical Site #2 Salt Lake City, Utah 84112	Active, not recruiting
Exelixis Clinical Site #30 Blacksburg, Virginia 24060	Active, not recruiting
Exelixis Clinical Site #14 Charlottesville, Virginia 22908	Active, not recruiting
Australia
Exelixis Clinical Site #98 Albury, New South Wales 2640	Active, not recruiting
Exelixis Clinical Site #101 Camperdown, New South Wales 2050	Active, not recruiting
Exelixis Clinical Site #115 Gosford, New South Wales 2250	Active, not recruiting
Exelixis Clinical Site #112 North Ryde, New South Wales 2109	Active, not recruiting
Exelixis Clinical Site #123 Randwick, New South Wales 2031	Active, not recruiting
Exelixis Clinical Site #99 St Albans, Victoria 3021	Active, not recruiting
Belgium
Exelixis Clinical Site #52 Gent 9000	Active, not recruiting
Exelixis Clinical Site #54 Leuven 3000	Active, not recruiting
France
Exelixis Clinical Site #88 La Roche-sur-Yon, Cedex 9 85925	Active, not recruiting
Exelixis Clinical Site #8 Villejuif, Cedex 94805	Active, not recruiting
Exelixis Clinical Site #92 Bordeaux 33076	Active, not recruiting
Exelixis Clinical Site #93 Brest 29229	Active, not recruiting
Exelixis Clinical Site #87 CAEN Cedex 05 14076	Active, not recruiting
Exelixis Clinical Site #69 Le Mans 72000	Active, not recruiting
Exelixis Clinical Site #97 Lille 59000	Active, not recruiting
Exelixis Clinical Site #89 Lyon Cedex 08 69373	Active, not recruiting
Exelixis Clinical Site #109 Marseille 13273	Active, not recruiting
Exelixis Clinical Site #104 Nice Cedex 02 06189	Active, not recruiting
Exelixis Clinical Site #80 Nîmes Cedex 09 30029	Active, not recruiting
Exelixis Clinical Site #78 Paris 75005	Active, not recruiting
Exelixis Clinical Site #7 Paris 75010	Active, not recruiting
Exelixis Clinical Site #68 Paris 75013	Active, not recruiting
Exelixis Clinical Site #72 Paris 75015	Active, not recruiting
Exelixis Clinical Site #82 Saint-Grégoire 35760	Active, not recruiting
Exelixis Clinical Site #119 Strasbourg 67000	Active, not recruiting
Exelixis Clinical Site #107 Suresnes 92150	Active, not recruiting
Exelixis Clinical Site #105 Vandoeuvre les nancy 54519	Active, not recruiting
Germany
Exelixis Clinical Site #56 Düsseldorf, Nordrhein-Westfalen 40225	Active, not recruiting
Exelixis Clinical Site #36 Tübingen 72076	Active, not recruiting
Italy
Exelixis Clinical Site #84 Meldola, FC 47014	Active, not recruiting
Exelixis Clinical Site #47 Rozzano, Milano 20089	Active, not recruiting
Exelixis Clinical Site #108 Milano 20132	Active, not recruiting
Exelixis Clinical Site #103 Milano 20133	Active, not recruiting
Exelixis Clinical Site #25 Milano 20133	Active, not recruiting
Exelixis Clinical Site #4 Milano 20133	Active, not recruiting
Exelixis Clinical Site #85 Napoli 80131	Active, not recruiting
Exelixis Clinical Site #121 Pavia 27100	Active, not recruiting
Exelixis Clinical Site #110 Roma 00168	Active, not recruiting
Netherlands
Exelixis Clinical Site #12 Nijmegen, Gelderland 6525 GA	Active, not recruiting
Spain
Exelixis Clinical Site #74 Santiago De Compostela, A Coruña 15706	Active, not recruiting
Exelixis Clinical Site #91 Elche, Alicante 03203	Active, not recruiting
Exelixis Clinical Site #94 Oviedo, Asturias 33011	Active, not recruiting
Exelixis Clinical Site #70 Palma De Mallorca, Baleares 07120 / 07010	Active, not recruiting
Exelixis Clinical Site #113 Badalona, Barcelona 08916	Active, not recruiting
Exelixis Clinical Site #116 Sabadell, Barcelona 08208	Active, not recruiting
Exelixis Clinical Site #96 Jeréz De La Frontera, Cádiz 11407	Active, not recruiting
Exelixis Clinical Site #90 Pamplona, Navarra 31008	Active, not recruiting
Exelixis Clinical Site #117 La Laguna, Santa Cruz De Tenerife 38320	Active, not recruiting
Exelixis Clinical Site #75 Barcelona 08003	Active, not recruiting
Exelixis Clinical Site #58 Barcelona 08022	Active, not recruiting
Exelixis Clinical Site #83 Barcelona 08023	Active, not recruiting
Exelixis Clinical Site #86 Barcelona 08025	Active, not recruiting
Exelixis Clinical Site #28 Barcelona 08035	Active, not recruiting
Exelixis Clinical Site #9 Barcelona 08035	Active, not recruiting
Exelixis Clinical Site #73 Barcelona 08036	Active, not recruiting
Exelixis Clinical Site #118 Girona 17007	Active, not recruiting
Exelixis Clinical Site #77 Madrid 28034	Active, not recruiting
Exelixis Clinical Site #106 Madrid 28040	Active, not recruiting
Exelixis Clinical Site #111 Madrid 28040	Active, not recruiting
Exelixis Clinical Site #22 Madrid 28041	Active, not recruiting
Exelixis Clinical Site #5 Madrid 28041	Active, not recruiting
Exelixis Clinical Site #81 Madrid 28046	Active, not recruiting
Exelixis Clinical Site #100 Málaga 29010	Active, not recruiting
United Kingdom
Exelixis Clinical Site #122 Middlesex, England HA6 2RN	Active, not recruiting
Exelixis Clinical Site #120 Preston, England PR2 9HT	Active, not recruiting
Exelixis Clinical Site #124 Cardiff, Wales CF14 2TL	Active, not recruiting
Exelixis Clinical Site #19 London EC1M 6BQ	Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

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.

Exclusion Criteria

Exclusion Criteria:

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

Date Trial Added

2017-05-31

Updated Date

2023-07-27