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

August 13, 2025 updated by: Exelixis

A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal cancer (CRC), head and neck (H&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Dose Escalation Stage: to determine the schedule and maximum tolerated dose (MTD) and/or recommended Expansion Stage dose of cabozantinib when taken in combination with a standard dosing regimen of atezolizumab (1200 mg infusion, once every 3 weeks).
  • Expansion Stage: to determine the preliminary efficacy (objective response rate [ORR] per RECIST 1.1) and safety of the recommended combination dose of cabozantinib with atezolizumab in eighteen tumor-specific cohorts including subjects with advanced UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H&N, and DTC.
  • Exploratory SAC Cohorts: Descriptive efficacy, safety, PK, and biomarker analyses of single-agent cabozantinib in UC, NSCLC, and CRPC subjects. Descriptive efficacy and safety analyses of combination therapy after progression on single-agent therapy
  • Exploratory SAA Cohort: Descriptive efficacy, safety, PK, and biomarker analyses of single-agent atezolizumab in CRPC subjects. Descriptive efficacy and safety analyses of combination therapy after progression on single-agent therapy

Study Type

Interventional

Enrollment (Actual)

914

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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)
  2. Measurable disease per RECIST 1.1 as determined by the investigator.
  3. Tumor tissue material available (archival or recent tumor biopsy)
  4. 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.
  5. Age eighteen years or older on the day of consent.
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  7. Adequate organ and marrow function.
  8. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.
  9. Female subjects of childbearing potential must not be pregnant at screening.

Exclusion Criteria:

  1. 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.
  2. Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks before first dose of study treatment.
  3. Concomitant anticoagulation with oral anticoagulants.
  4. 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.
  5. Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
  6. 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).
  7. Pregnant or lactating females.
  8. Previously identified allergy or hypersensitivity to components of the study treatment formulations.
  9. Diagnosis of another malignancy within 2 years before first dose of study treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
Subjects will accrue in cohorts of 3-6 subjects for evaluation of cabozantinib tablet dose of either 20 mg, 40 mg, and 60 mg orally qd in combination with standard dosing regimen of atezolizumab (1200 mg infusion q3w). A standard "3 plus 3" design will be utilized to determine a recommended combination dosing regimen for the Expansion Stage.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 1
RCC subjects with clear cell histology who have not received prior systemic anticancer therapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 2
UC subjects (including bladder, renal pelvis, ureter, urethra) who have progressed on or after platinum-containing chemotherapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 3
UC subjects (including bladder, renal pelvis, ureter, urethra) who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 4
UC subjects (including bladder, renal pelvis, ureter, urethra) eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 5
UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior immune check-point inhibitor (ICI) (anti-PD1 or anti-PD-L1) therapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 6
CRPC subjects who have radiographically progressed in soft tissue on or after enzalutamide and/or abiraterone acetate for metastatic disease.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 7
Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (ICI) (anti-PD-1 or anti-PD-L1) therapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 8
Stage IV non-squamous NSCLC subjects with positive PD-L1 expression and without prior systemic anticancer therapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 9
Stage IV nonsquamous NSCLC subjects with sensitizing EGFR mutation who have radiographically progressed during or following prior treatment with an EGFR-targeting TKI. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 10
RCC subjects with non-clear cell histology who have had up to one prior VEGFR-targeting TKI therapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 11
TNBC subjects who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 12
OC subjects (including primary peritoneal cancer and fallopian tube cancer) who have platinum-resistant or refractory disease who have had up to two lines of prior systemic anticancer therapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 13
EC subjects (serous or endometrioid histology) who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 14
HCC subjects (Child-Pugh score A) who have not received prior systemic anticancer therapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 15
GC/GEJC/LEC subjects who have radiographically progressed during or following platinum-containing or fluoropyrimidine-containing chemotherapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 16
CRC subjects who have radiographically progressed during or following systemic chemotherapy that contained fluoropyrimidine in combination with oxaliplatin or irinotecan.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 17
H&N cancer subjects who have radiographically progressed during or following prior platinum-containing chemotherapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 18
DTC subjects (follicular, papillary, and poorly differentiated histologies) who are radioactive iodine (RAI) refractory or deemed ineligible for treatment with RAI.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 19 (SAC)
UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 20 (SAC)
Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 21 (SAC)
Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC. Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 22 (SAA)
Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC. Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Experimental: Expansion Cohort 23
Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184
Experimental: Expansion Cohort 24
Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with at least one NHT and have received docetaxel for mCRPC
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
Drug: atezolizumab
Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
Other Names:
  • Tecentriq
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
Other Names:
  • Cabometyx
  • XL184
Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
Other Names:
  • Cabometyx
  • XL184

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Escalation: MTD/Recommended Dose
Time Frame: Up to Day 21
To determine the maximum tolerated dose (MTD) and/or recommended dose and schedule for the subsequent Expansion Stage of daily oral administration of cabozantinib in subjects with solid tumors when taken in combination with atezolizumab.
Up to Day 21
Dose Expansion: ORR
Time Frame: Up to a maximum of 59 months
To evaluate preliminary efficacy by estimating the Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1.
Up to a maximum of 59 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of nonserious AEs and SAEs (Safety)
Time Frame: From first dose to 30 days following last dose (up to a maximum of 59 months)
To assess safety for the combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs), including immune-related adverse events (irAEs) and adverse events of special interest (AESIs).
From first dose to 30 days following last dose (up to a maximum of 59 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2017

Primary Completion (Actual)

February 21, 2023

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL184-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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