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

Primary Purpose

Urothelial Carcinoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer

Status

Active

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

cabozantinib

atezolizumab

cabozantinib

About this trial

This is an interventional treatment trial for Urothelial Carcinoma focused on measuring Kidney, Bladder, Renal pelvis, Ureter, Urethra, Cancer, Prostate, Castration-resistant, Lung, Breast, Ovarian, Endometrial, Liver, Stomach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Arm Type

Experimental

Arm Label

Dose Escalation

Expansion Cohort 1

Expansion Cohort 2

Expansion Cohort 3

Expansion Cohort 4

Expansion Cohort 5

Expansion Cohort 6

Expansion Cohort 7

Expansion Cohort 8

Expansion Cohort 9

Expansion Cohort 10

Expansion Cohort 11

Expansion Cohort 12

Expansion Cohort 13

Expansion Cohort 14

Expansion Cohort 15

Expansion Cohort 16

Expansion Cohort 17

Expansion Cohort 18

Expansion Cohort 19 (SAC)

Expansion Cohort 20 (SAC)

Expansion Cohort 21 (SAC)

Expansion Cohort 22 (SAA)

Expansion Cohort 23

Expansion Cohort 24

Arm Description

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.

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

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

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

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

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.

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

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.

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

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.

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

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.

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.

EC subjects (serous or endometrioid histology) who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy.

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

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

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

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.

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

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.

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.

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.

Outcomes

Primary Outcome Measures

Dose Escalation: MTD/Recommended Dose

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.

Dose Expansion: ORR

To evaluate preliminary efficacy by estimating the Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1.

Secondary Outcome Measures

Incidence and severity of nonserious AEs and SAEs (Safety)

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).

Full Information

NCT ID

NCT03170960

First Posted

May 23, 2017

Last Updated

July 24, 2023

Sponsor

Exelixis

1. Study Identification

Unique Protocol Identification Number

NCT03170960

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 5, 2017 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Exelixis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Kidney, Bladder, Renal pelvis, Ureter, Urethra, Cancer, Prostate, Castration-resistant, Lung, Breast, Ovarian, Endometrial, Liver, Stomach

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Model Description

Dose Escalation followed by Dose Expansion

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1732 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation

Arm Type

Experimental

Arm Description

Arm Title

Expansion Cohort 1

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 2

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 3

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 4

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 5

Arm Type

Experimental

Arm Description

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.

Arm Title

Expansion Cohort 6

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 7

Arm Type

Experimental

Arm Description

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.

Arm Title

Expansion Cohort 8

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 9

Arm Type

Experimental

Arm Description

Arm Title

Expansion Cohort 10

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 11

Arm Type

Experimental

Arm Description

Arm Title

Expansion Cohort 12

Arm Type

Experimental

Arm Description

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.

Arm Title

Expansion Cohort 13

Arm Type

Experimental

Arm Description

EC subjects (serous or endometrioid histology) who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy.

Arm Title

Expansion Cohort 14

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 15

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 16

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 17

Arm Type

Experimental

Arm Description

Arm Title

Expansion Cohort 18

Arm Type

Experimental

Arm Description

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

Arm Title

Expansion Cohort 19 (SAC)

Arm Type

Experimental

Arm Description

Arm Title

Expansion Cohort 20 (SAC)

Arm Type

Experimental

Arm Description

Arm Title

Expansion Cohort 21 (SAC)

Arm Type

Experimental

Arm Description

Arm Title

Expansion Cohort 22 (SAA)

Arm Type

Experimental

Arm Description

Arm Title

Expansion Cohort 23

Arm Type

Experimental

Arm Description

Arm Title

Expansion Cohort 24

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

cabozantinib

Other Intervention Name(s)

Cabometyx, XL184

Intervention Description

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

Intervention Name(s)

atezolizumab

Other Intervention Name(s)

Tecentriq

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cabozantinib

Other Intervention Name(s)

Cabometyx, XL184

Intervention Description

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

Intervention Name(s)

cabozantinib

Other Intervention Name(s)

Cabometyx, XL184

Intervention Description

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

Primary Outcome Measure Information:

Title

Dose Escalation: MTD/Recommended Dose

Description

Time Frame

Up to 6 months

Title

Dose Expansion: ORR

Description

To evaluate preliminary efficacy by estimating the Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1.

Time Frame

Up to 31 months

Secondary Outcome Measure Information:

Title

Incidence and severity of nonserious AEs and SAEs (Safety)

Description

Time Frame

Up to 41 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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.

Facility Information:

Facility Name

Exelixis Clinical Site #53

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Exelixis Clinical Site #18

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Facility Name

Exelixis Clinical Site #1

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Exelixis Clinical Site #20

City

La Jolla

State/Province

California

ZIP/Postal Code

92090

Country

United States

Facility Name

Exelixis Clinical Site #46

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Exelixis Clinical Site #51

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Exelixis Clinical Site #62

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Exelixis Clinical Site #21

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Exelixis Clinical Site #34

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Exelixis Clinical Site #50

City

Denver

State/Province

Colorado

ZIP/Postal Code

80218

Country

United States

Facility Name

Exelixis Clinical Site #42

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

Facility Name

Exelixis Clinical Site #48

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Exelixis Clinical Site #16

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Exelixis Clinical Site #76

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Exelixis Clinical Site #60

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

Exelixis Clinical Site #79

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30341

Country

United States

Facility Name

Exelixis Clinical Site #32

City

Harvey

State/Province

Illinois

ZIP/Postal Code

60426

Country

United States

Facility Name

Exelixis Clinical Site #23

City

Fairway

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

Exelixis Clinical Site #57

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Exelixis Clinical Site #24

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Facility Name

Exelixis Clinical Site #10

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Exelixis Clinical Site #3

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Exelixis Clinical Site #17

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Exelixis Clinical Site #65

City

Bolivar

State/Province

Missouri

ZIP/Postal Code

65613

Country

United States

Facility Name

Exelixis Clinical Site #43

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

Exelixis Clinical Site #35

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Exelixis Clinical Site #59

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Exelixis Clinical Site #61

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

Exelixis Clinical Site #38

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08103

Country

United States

Facility Name

Exelixis Clinical Site #27

City

East Brunswick

State/Province

New Jersey

ZIP/Postal Code

08816

Country

United States

Facility Name

Exelixis Clinical Site #31

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Facility Name

Exelixis Clinical Site #37

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Exelixis Clinical Site #40

City

East Setauket

State/Province

New York

ZIP/Postal Code

11733

Country

United States

Facility Name

Exelixis Clinical Site #11

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Exelixis Clinical Site #67

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Exelixis Clinical Site #49

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Exelixis Clinical Site #64

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

Exelixis Clinical Site #71

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Exelixis Clinical Site #6

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Exelixis Clinical Site #102

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Exelixis Clinical Site #45

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Exelixis Clinical Site #41

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Exelixis Clinical Site #15

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Exelixis Clinical Site #55

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

Exelixis Clinical Site #66

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Exelixis Clinical Site #95

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Exelixis Clinical Site #13

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Exelixis Clinical Site #26

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Exelixis Clinical Site #114

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Exelixis Clinical Site #29

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Exelixis Clinical Site #39

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Exelixis Clinical Site #44

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Exelixis Clinical Site #33

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

Exelixis Clinical Site #63

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Exelixis Clinical Site #2

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Exelixis Clinical Site #30

City

Blacksburg

State/Province

Virginia

ZIP/Postal Code

24060

Country

United States

Facility Name

Exelixis Clinical Site #14

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Exelixis Clinical Site #98

City

Albury

State/Province

New South Wales

ZIP/Postal Code

2640

Country

Australia

Facility Name

Exelixis Clinical Site #101

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Exelixis Clinical Site #115

City

Gosford

State/Province

New South Wales

ZIP/Postal Code

2250

Country

Australia

Facility Name

Exelixis Clinical Site #112

City

North Ryde

State/Province

New South Wales

ZIP/Postal Code

2109

Country

Australia

Facility Name

Exelixis Clinical Site #123

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

Exelixis Clinical Site #99

City

St Albans

State/Province

Victoria

ZIP/Postal Code

3021

Country

Australia

Facility Name

Exelixis Clinical Site #52

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Exelixis Clinical Site #54

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Exelixis Clinical Site #88

City

La Roche-sur-Yon

State/Province

Cedex 9

ZIP/Postal Code

85925

Country

France

Facility Name

Exelixis Clinical Site #8

City

Villejuif

State/Province

Cedex

ZIP/Postal Code

94805

Country

France

Facility Name

Exelixis Clinical Site #92

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Exelixis Clinical Site #93

City

Brest

ZIP/Postal Code

29229

Country

France

Facility Name

Exelixis Clinical Site #87

City

CAEN Cedex 05

ZIP/Postal Code

14076

Country

France

Facility Name

Exelixis Clinical Site #69

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

Exelixis Clinical Site #97

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Exelixis Clinical Site #89

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Exelixis Clinical Site #109

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Exelixis Clinical Site #104

City

Nice Cedex 02

ZIP/Postal Code

06189

Country

France

Facility Name

Exelixis Clinical Site #80

City

Nîmes Cedex 09

ZIP/Postal Code

30029

Country

France

Facility Name

Exelixis Clinical Site #78

City

Paris

ZIP/Postal Code

75005

Country

France

Facility Name

Exelixis Clinical Site #7

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Exelixis Clinical Site #68

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Exelixis Clinical Site #72

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Exelixis Clinical Site #82

City

Saint-Grégoire

ZIP/Postal Code

35760

Country

France

Facility Name

Exelixis Clinical Site #119

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Exelixis Clinical Site #107

City

Suresnes

ZIP/Postal Code

92150

Country

France

Facility Name

Exelixis Clinical Site #105

City

Vandoeuvre les nancy

ZIP/Postal Code

54519

Country

France

Facility Name

Exelixis Clinical Site #56

City

Düsseldorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

40225

Country

Germany

Facility Name

Exelixis Clinical Site #36

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Exelixis Clinical Site #84

City

Meldola

State/Province

ZIP/Postal Code

47014

Country

Italy

Facility Name

Exelixis Clinical Site #47

City

Rozzano

State/Province

Milano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Exelixis Clinical Site #108

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Exelixis Clinical Site #103

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Exelixis Clinical Site #25

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Exelixis Clinical Site #4

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Exelixis Clinical Site #85

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Exelixis Clinical Site #121

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Exelixis Clinical Site #110

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Exelixis Clinical Site #12

City

Nijmegen

State/Province

Gelderland

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Exelixis Clinical Site #74

City

Santiago De Compostela

State/Province

A Coruña

ZIP/Postal Code

15706

Country

Spain

Facility Name

Exelixis Clinical Site #91

City

Elche

State/Province

Alicante

ZIP/Postal Code

03203

Country

Spain

Facility Name

Exelixis Clinical Site #94

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Name

Exelixis Clinical Site #70

City

Palma De Mallorca

State/Province

Baleares

ZIP/Postal Code

07120 / 07010

Country

Spain

Facility Name

Exelixis Clinical Site #113

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Exelixis Clinical Site #116

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Exelixis Clinical Site #96

City

Jeréz De La Frontera

State/Province

Cádiz

ZIP/Postal Code

11407

Country

Spain

Facility Name

Exelixis Clinical Site #90

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Exelixis Clinical Site #117

City

La Laguna

State/Province

Santa Cruz De Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Exelixis Clinical Site #75

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Exelixis Clinical Site #58

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

Facility Name

Exelixis Clinical Site #83

City

Barcelona

ZIP/Postal Code

08023

Country

Spain

Facility Name

Exelixis Clinical Site #86

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Exelixis Clinical Site #28

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Exelixis Clinical Site #9

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Exelixis Clinical Site #73

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Exelixis Clinical Site #118

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Exelixis Clinical Site #77

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Exelixis Clinical Site #106

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Exelixis Clinical Site #111

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Exelixis Clinical Site #22

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Exelixis Clinical Site #5

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Exelixis Clinical Site #81

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Exelixis Clinical Site #100

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Exelixis Clinical Site #122

City

Middlesex

State/Province

England

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Exelixis Clinical Site #120

City

Preston

State/Province

England

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

Exelixis Clinical Site #124

City

Cardiff

State/Province

Wales

ZIP/Postal Code

CF14 2TL

Country

United Kingdom

Facility Name

Exelixis Clinical Site #19

City

London

ZIP/Postal Code

EC1M 6BQ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35690072

Citation

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.

Results Reference

derived

PubMed Identifier

34491815

Citation

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.

Results Reference

derived

Learn more about this trial

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

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

Urothelial Carcinoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm 25

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial