Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03170960)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Exelixis Clinical Site #53 — Gilbert, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (124 Sites)
Showing the first 25 of 124 sites.
- Exelixis Clinical Site #53 — Gilbert, Arizona
- Exelixis Clinical Site #18 — Phoenix, Arizona
- Exelixis Clinical Site #1 — Duarte, California
- Exelixis Clinical Site #20 — La Jolla, California
- Exelixis Clinical Site #46 — Los Angeles, California
- Exelixis Clinical Site #51 — Newport Beach, California
- Exelixis Clinical Site #62 — Santa Monica, California
- Exelixis Clinical Site #21 — Stanford, California
- Exelixis Clinical Site #34 — Denver, Colorado
- Exelixis Clinical Site #50 — Denver, Colorado
- Exelixis Clinical Site #42 — New Haven, Connecticut
- Exelixis Clinical Site #48 — Washington D.C., District of Columbia
- Exelixis Clinical Site #16 — Jacksonville, Florida
- Exelixis Clinical Site #76 — Tampa, Florida
- Exelixis Clinical Site #60 — Atlanta, Georgia
- Exelixis Clinical Site #79 — Atlanta, Georgia
- Exelixis Clinical Site #32 — Harvey, Illinois
- Exelixis Clinical Site #23 — Fairway, Kansas
- Exelixis Clinical Site #57 — Lexington, Kentucky
- Exelixis Clinical Site #24 — New Orleans, Louisiana
- Exelixis Clinical Site #10 — Boston, Massachusetts
- Exelixis Clinical Site #3 — Detroit, Michigan
- Exelixis Clinical Site #17 — Rochester, Minnesota
- Exelixis Clinical Site #65 — Bolivar, Missouri
- Exelixis Clinical Site #43 — Kansas City, Missouri
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma — Philadelphia, Pennsylvania
- A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma — Houston, Texas
- A Phase II Multicenter Study of Chemotherapy Versus Chemotherapy Plus Durvalumab (MEDI 4736) in Patients With Lymph Node Positive Urothelial Carcinoma of the Bladder — Bloomington, Indiana
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Explore by condition: All Urothelial Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.