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NCT03170960 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by Exelixis.

Active
Registry status
Phase 1
Development phase
914
Enrollment target
20
Study locations

NCT03170960: Active Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by Exelixis.

NCT03170960 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that is active but no longer recruiting, run by Exelixis. The registered enrollment target is 914 participants, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (41% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03170960, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, is active but no longer recruiting, sponsored by Exelixis.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
914 participants
Enrollment target
20
Study locations

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.

Primary Outcome

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.

Conditions Studied

Non-Small Cell Lung Cancer Ovarian Cancer Endometrial Cancer Gastric Cancer Hepatocellular Carcinoma Renal Cell Carcinoma Triple Negative Breast Cancer Urothelial Carcinoma Gastroesophageal Junction Adenocarcinoma Castration-resistant Prostate Cancer

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
Exelixis

48 total trials

What the registry record for NCT03170960 still lists

NCT03170960 is an interventional study that assigns participants to a tested intervention. The registered 914 participants enrollment target is mid-sized for trials with a published cap, above the 650-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (41% higher).

The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which cabozantinib is the first listed.

NCT03170960 names 20 study sites across 11 states, led by California, Arizona, Colorado.

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: Non-Small Cell Lung Cancer, Ovarian Cancer, Endometrial Cancer, Gastric Cancer, Hepatocellular Carcinoma.

What interventions are being tested in trial NCT03170960?

The interventions under investigation include: cabozantinib (DRUG), atezolizumab (DRUG).

Who is sponsoring clinical trial NCT03170960?

This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Non-Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03170960's enrollment target sits among peer trials

914 26th of 454 higher than 429 of 454 other Non-Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03170960, the US trial registry maintained by the National Library of Medicine. NCT03170960 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.