Last updated on March 2019

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


Brief description of study

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 and gastroesophageal junction cancer (GC/GEJC), 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. Two exploratory single-agent cabozantinib (SAC) cohorts will also be enrolled with UC or NSCLC subjects.

Detailed Study 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, CRC, H&N, and DTC.
    • Exploratory SAC Cohorts: Descriptive efficacy, safety, PK, and biomarker analyses of single-agent cabozantinib in UC and NSCLC subjects

Clinical Study Identifier: NCT03170960

Contact Investigators or Research Sites near you

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Exelixis Clinical Site #1

Duarte, CA United States
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Exelixis Clinical Site #2

Salt Lake City, UT United States
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Exelixis Clinical Site #3

Detroit, MI United States
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Exelixis Clinical Site #6

Oklahoma City, OK United States
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Exelixis Clinical Site #18

Phoenix, AZ United States
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Exelixis Clinical Site #16

Jacksonville, FL United States
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Exelixis Clinical Site #17

Rochester, MN United States
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Exelixis Clinical Site #11

New York, NY United States
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Exelixis Clinical Site #15

Philadelphia, PA United States
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Exelixis Clinical Site #14

Charlottesville, VA United States
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Exelixis Clinical Site #20

La Jolla, CA United States
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Exelixis Clinical Site #21

Stanford, CA United States
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Exelixis Clinical Site #8

Fairway, KS United States
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Recruitment Status: Open


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