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ACTIVE NOT RECRUITING Phase 1

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

NCT03170960 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG cabozantinib
  • DRUG atezolizumab

Study Locations (20)

California

  • Exelixis Clinical Site #1 — Duarte
  • Exelixis Clinical Site #20 — La Jolla
  • Exelixis Clinical Site #46 — Los Angeles
  • Exelixis Clinical Site #51 — Newport Beach
  • Exelixis Clinical Site #62 — Santa Monica
  • Exelixis Clinical Site #21 — Stanford

Arizona

  • Exelixis Clinical Site #53 — Gilbert
  • Exelixis Clinical Site #18 — Phoenix

Colorado

  • Exelixis Clinical Site #34 — Denver
  • Exelixis Clinical Site #50 — Denver

Florida

  • Exelixis Clinical Site #16 — Jacksonville
  • Exelixis Clinical Site #76 — Tampa

Georgia

  • Exelixis Clinical Site #60 — Atlanta
  • Exelixis Clinical Site #79 — Atlanta

Connecticut

  • Exelixis Clinical Site #42 — New Haven

District of Columbia

  • Exelixis Clinical Site #48 — Washington D.C.

Illinois

  • Exelixis Clinical Site #32 — Harvey

Trial Details

FieldValue
Enrollment Target 914 participants
Start Date 2017-09-05
Est. Completion 2027-09-30
Phase Phase 1

Sponsor

Exelixis

54 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03170960

The ClinicalTrials.gov registry entry for NCT03170960 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 914 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Exelixis, which has 54 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions — of which cabozantinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03170960 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03170960 about?

NCT03170960 is a clinical study titled "Study of Cabozantinib 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...

What is the current status of trial NCT03170960?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 914 participants. The study started on 2017-09-05. Estimated completion is 2027-09-30.

What conditions does trial NCT03170960 study?

This clinical trial studies the following conditions: Ovarian Cancer, Endometrial Cancer, Gastric Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03170960?

The interventions under investigation include: cabozantinib (DRUG), atezolizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03170960?

This trial is sponsored by Exelixis, which has 54 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03170960 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial