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

NCT ID: NCT03170960

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

914 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-05

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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* 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

Conditions

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Urothelial Carcinoma Renal Cell Carcinoma Non-Small Cell Lung Cancer Castration-resistant Prostate Cancer Triple Negative Breast Cancer Ovarian Cancer Endometrial Cancer Hepatocellular Carcinoma Gastric Cancer Gastroesophageal Junction Adenocarcinoma Colorectal Cancer Head and Neck Cancer Differentiated Thyroid Cancer Lower Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Dose Escalation followed by Dose Expansion
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

Expansion Cohort 1

RCC subjects with clear cell histology who have not received prior systemic anticancer therapy.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Expansion Cohort 2

UC subjects (including bladder, renal pelvis, ureter, urethra) who have progressed on or after platinum-containing chemotherapy.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

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.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Expansion Cohort 4

UC subjects (including bladder, renal pelvis, ureter, urethra) eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

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.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Expansion Cohort 6

CRPC subjects who have radiographically progressed in soft tissue on or after enzalutamide and/or abiraterone acetate for metastatic disease.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

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.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Expansion Cohort 8

Stage IV non-squamous NSCLC subjects with positive PD-L1 expression and without prior systemic anticancer therapy.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

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.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Expansion Cohort 10

RCC subjects with non-clear cell histology who have had up to one prior VEGFR-targeting TKI therapy.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

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.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

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.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

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.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Expansion Cohort 14

HCC subjects (Child-Pugh score A) who have not received prior systemic anticancer therapy.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Expansion Cohort 15

GC/GEJC/LEC subjects who have radiographically progressed during or following platinum-containing or fluoropyrimidine-containing chemotherapy.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Expansion Cohort 16

CRC subjects who have radiographically progressed during or following systemic chemotherapy that contained fluoropyrimidine in combination with oxaliplatin or irinotecan.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

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.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Expansion Cohort 18

DTC subjects (follicular, papillary, and poorly differentiated histologies) who are radioactive iodine (RAI) refractory or deemed ineligible for treatment with RAI.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

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.

Group Type EXPERIMENTAL

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd

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.

Group Type EXPERIMENTAL

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd

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.

Group Type EXPERIMENTAL

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd

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.

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

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

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

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

Group Type EXPERIMENTAL

atezolizumab

Intervention Type DRUG

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

cabozantinib

Intervention Type DRUG

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Interventions

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cabozantinib

Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.

Intervention Type DRUG

atezolizumab

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

Intervention Type 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

Intervention Type DRUG

cabozantinib

Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd

Intervention Type DRUG

Other Intervention Names

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Cabometyx XL184 Tecentriq Cabometyx XL184 Cabometyx XL184

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Exelixis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Exelixis Clinical Site #53

Gilbert, Arizona, United States

Site Status

Exelixis Clinical Site #18

Phoenix, Arizona, United States

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Exelixis Clinical Site #1

Duarte, California, United States

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Exelixis Clinical Site #20

La Jolla, California, United States

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Exelixis Clinical Site #46

Los Angeles, California, United States

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Exelixis Clinical Site #51

Newport Beach, California, United States

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Exelixis Clinical Site #62

Santa Monica, California, United States

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Exelixis Clinical Site #21

Stanford, California, United States

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Exelixis Clinical Site #34

Denver, Colorado, United States

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Exelixis Clinical Site #50

Denver, Colorado, United States

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Exelixis Clinical Site #42

New Haven, Connecticut, United States

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Exelixis Clinical Site #48

Washington D.C., District of Columbia, United States

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Exelixis Clinical Site #16

Jacksonville, Florida, United States

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Exelixis Clinical Site #76

Tampa, Florida, United States

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Exelixis Clinical Site #60

Atlanta, Georgia, United States

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Exelixis Clinical Site #79

Atlanta, Georgia, United States

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Exelixis Clinical Site #32

Harvey, Illinois, United States

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Exelixis Clinical Site #23

Fairway, Kansas, United States

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Exelixis Clinical Site #57

Lexington, Kentucky, United States

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Exelixis Clinical Site #24

New Orleans, Louisiana, United States

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Exelixis Clinical Site #10

Boston, Massachusetts, United States

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Exelixis Clinical Site #3

Detroit, Michigan, United States

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Exelixis Clinical Site #17

Rochester, Minnesota, United States

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Exelixis Clinical Site #65

Bolivar, Missouri, United States

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Exelixis Clinical Site #43

Kansas City, Missouri, United States

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Exelixis Clinical Site #35

Omaha, Nebraska, United States

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Exelixis Clinical Site #59

Omaha, Nebraska, United States

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Exelixis Clinical Site #61

Las Vegas, Nevada, United States

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Exelixis Clinical Site #38

Camden, New Jersey, United States

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Exelixis Clinical Site #27

East Brunswick, New Jersey, United States

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Exelixis Clinical Site #31

New Brunswick, New Jersey, United States

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Exelixis Clinical Site #40

East Setauket, New York, United States

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Exelixis Clinical Site #11

New York, New York, United States

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Exelixis Clinical Site #37

The Bronx, New York, United States

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Exelixis Clinical Site #67

Cleveland, Ohio, United States

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Exelixis Clinical Site #49

Columbus, Ohio, United States

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Exelixis Clinical Site #64

Kettering, Ohio, United States

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Exelixis Clinical Site #71

Oklahoma City, Oklahoma, United States

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Exelixis Clinical Site #6

Oklahoma City, Oklahoma, United States

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Exelixis Clinical Site #102

Portland, Oregon, United States

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Exelixis Clinical Site #45

Portland, Oregon, United States

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Exelixis Clinical Site #41

Bethlehem, Pennsylvania, United States

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Exelixis Clinical Site #15

Philadelphia, Pennsylvania, United States

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Exelixis Clinical Site #55

Philadelphia, Pennsylvania, United States

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Exelixis Clinical Site #66

Pittsburgh, Pennsylvania, United States

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Exelixis Clinical Site #95

Charleston, South Carolina, United States

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Exelixis Clinical Site #13

Dallas, Texas, United States

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Exelixis Clinical Site #26

Dallas, Texas, United States

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Exelixis Clinical Site #114

Fort Worth, Texas, United States

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Exelixis Clinical Site #29

Houston, Texas, United States

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Exelixis Clinical Site #39

Houston, Texas, United States

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Exelixis Clinical Site #44

Houston, Texas, United States

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Exelixis Clinical Site #33

Lubbock, Texas, United States

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Exelixis Clinical Site #63

San Antonio, Texas, United States

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Exelixis Clinical Site #2

Salt Lake City, Utah, United States

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Exelixis Clinical Site #30

Blacksburg, Virginia, United States

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Exelixis Clinical Site #14

Charlottesville, Virginia, United States

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Exelixis Clinical Site #98

Albury, New South Wales, Australia

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Exelixis Clinical Site #101

Camperdown, New South Wales, Australia

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Exelixis Clinical Site #115

Gosford, New South Wales, Australia

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Exelixis Clinical Site #112

North Ryde, New South Wales, Australia

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Exelixis Clinical Site #123

Randwick, New South Wales, Australia

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Exelixis Clinical Site #99

St Albans, Victoria, Australia

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Exelixis Clinical Site #52

Ghent, , Belgium

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Exelixis Clinical Site #54

Leuven, , Belgium

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Exelixis Clinical Site #88

La Roche-sur-Yon, Cedex 9, France

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Exelixis Clinical Site #8

Villejuif, Cedex, France

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Exelixis Clinical Site #92

Bordeaux, , France

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Exelixis Clinical Site #93

Brest, , France

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Exelixis Clinical Site #87

Caen, , France

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Exelixis Clinical Site #69

Le Mans, , France

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Exelixis Clinical Site #97

Lille, , France

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Exelixis Clinical Site #89

Lyon, , France

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Exelixis Clinical Site #109

Marseille, , France

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Exelixis Clinical Site #104

Nice, , France

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Exelixis Clinical Site #80

Nîmes, , France

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Exelixis Clinical Site #78

Paris, , France

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Exelixis Clinical Site #7

Paris, , France

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Exelixis Clinical Site #68

Paris, , France

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Exelixis Clinical Site #72

Paris, , France

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Exelixis Clinical Site #82

Saint-Grégoire, , France

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Exelixis Clinical Site #119

Strasbourg, , France

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Exelixis Clinical Site #107

Suresnes, , France

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Exelixis Clinical Site #105

Vandœuvre-lès-Nancy, , France

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Exelixis Clinical Site #56

Düsseldorf, North Rhine-Westphalia, Germany

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Exelixis Clinical Site #36

Tübingen, , Germany

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Exelixis Clinical Site #84

Meldola, FC, Italy

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Exelixis Clinical Site #47

Rozzano, Milano, Italy

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Exelixis Clinical Site #108

Milan, , Italy

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Exelixis Clinical Site #103

Milan, , Italy

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Exelixis Clinical Site #25

Milan, , Italy

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Exelixis Clinical Site #4

Milan, , Italy

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Exelixis Clinical Site #85

Napoli, , Italy

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Exelixis Clinical Site #121

Pavia, , Italy

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Exelixis Clinical Site #110

Roma, , Italy

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Exelixis Clinical Site #12

Nijmegen, Gelderland, Netherlands

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Exelixis Clinical Site #74

Santiago de Compostela, A Coruña, Spain

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Exelixis Clinical Site #91

Elche, Alicante, Spain

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Exelixis Clinical Site #70

Palma de Mallorca, Balearic Islands, Spain

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Exelixis Clinical Site #113

Badalona, Barcelona, Spain

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Exelixis Clinical Site #116

Sabadell, Barcelona, Spain

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Exelixis Clinical Site #96

Jeréz de La Frontera, Cádiz, Spain

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Exelixis Clinical Site #90

Pamplona, Navarre, Spain

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Exelixis Clinical Site #94

Oviedo, Principality of Asturias, Spain

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Exelixis Clinical Site #117

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

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Exelixis Clinical Site #75

Barcelona, , Spain

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Exelixis Clinical Site #58

Barcelona, , Spain

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Exelixis Clinical Site #83

Barcelona, , Spain

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Exelixis Clinical Site #86

Barcelona, , Spain

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Exelixis Clinical Site #28

Barcelona, , Spain

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Exelixis Clinical Site #9

Barcelona, , Spain

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Exelixis Clinical Site #73

Barcelona, , Spain

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Exelixis Clinical Site #118

Girona, , Spain

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Exelixis Clinical Site #77

Madrid, , Spain

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Exelixis Clinical Site #106

Madrid, , Spain

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Exelixis Clinical Site #111

Madrid, , Spain

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Exelixis Clinical Site #22

Madrid, , Spain

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Exelixis Clinical Site #5

Madrid, , Spain

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Exelixis Clinical Site #81

Madrid, , Spain

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Exelixis Clinical Site #100

Málaga, , Spain

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Exelixis Clinical Site #122

Middlesex, England, United Kingdom

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Exelixis Clinical Site #120

Preston, England, United Kingdom

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Exelixis Clinical Site #124

Cardiff, Wales, United Kingdom

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Exelixis Clinical Site #19

London, , United Kingdom

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Countries

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United States Australia Belgium France Germany Italy Netherlands Spain United Kingdom

References

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Pal SK, Loriot Y, Necchi A, Singh P, Castellano D, Pagliaro L, Suarez C, McGregor BA, Vaishampayan UN, Hauke RJ, Powles T, Van Herpen CML, Courtney KD, Dreicer R, Sudhagoni R, Schwickart M, Andrianova S, Agarwal N. COSMIC-021 Phase Ib Study of Cabozantinib Plus Atezolizumab: Results from the Locally Advanced or Metastatic Urothelial Carcinoma Cohorts. J Clin Oncol. 2025 May 10;43(14):1650-1662. doi: 10.1200/JCO-24-01675. Epub 2025 Feb 18.

Reference Type DERIVED
PMID: 39965176 (View on PubMed)

Li D, Loriot Y, Burgoyne AM, Cleary JM, Santoro A, Lin D, Aix SP, Garrido-Laguna I, Sudhagoni R, Guo X, Andrianova S, Paulson S. Cabozantinib plus atezolizumab in previously untreated advanced hepatocellular carcinoma and previously treated gastric cancer and gastroesophageal junction adenocarcinoma: results from two expansion cohorts of a multicentre, open-label, phase 1b trial (COSMIC-021). EClinicalMedicine. 2023 Dec 21;67:102376. doi: 10.1016/j.eclinm.2023.102376. eCollection 2024 Jan.

Reference Type DERIVED
PMID: 38204489 (View on PubMed)

Agarwal N, McGregor B, Maughan BL, Dorff TB, Kelly W, Fang B, McKay RR, Singh P, Pagliaro L, Dreicer R, Srinivas S, Loriot Y, Vaishampayan U, Goel S, Curran D, Panneerselvam A, Schwickart M, Choueiri TK, Pal S. Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: results from an expansion cohort of a multicentre, open-label, phase 1b trial (COSMIC-021). Lancet Oncol. 2022 Jul;23(7):899-909. doi: 10.1016/S1470-2045(22)00278-9. Epub 2022 Jun 9.

Reference Type DERIVED
PMID: 35690072 (View on PubMed)

Pal SK, McGregor B, Suarez C, Tsao CK, Kelly W, Vaishampayan U, Pagliaro L, Maughan BL, Loriot Y, Castellano D, Srinivas S, McKay RR, Dreicer R, Hutson T, Dubey S, Werneke S, Panneerselvam A, Curran D, Scheffold C, Choueiri TK, Agarwal N. Cabozantinib in Combination With Atezolizumab for Advanced Renal Cell Carcinoma: Results From the COSMIC-021 Study. J Clin Oncol. 2021 Nov 20;39(33):3725-3736. doi: 10.1200/JCO.21.00939. Epub 2021 Sep 7.

Reference Type DERIVED
PMID: 34491815 (View on PubMed)

Other Identifiers

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XL184-021

Identifier Type: -

Identifier Source: org_study_id

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