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NCT04079712 · ClinicalTrials.gov registry record · Phase 2

Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors

A Phase 2 study of Metastatic Neuroendocrine Carcinoma and Metastatic Large-cell Neuroendocrine Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
17
Enrollment target
20
Study locations

NCT04079712: Active Phase 2 study of Metastatic Neuroendocrine Carcinoma and Metastatic Large-cell Neuroendocrine Carcinoma, sponsored by National Cancer Institute (NCI).

NCT04079712 is a Phase 2 study of Metastatic Neuroendocrine Carcinoma and Metastatic Large-cell Neuroendocrine Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04079712, a Phase 2 study of Metastatic Neuroendocrine Carcinoma and Metastatic Large-cell Neuroendocrine Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
17 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial studies how well the combination of XL184 (cabozantinib), nivolumab, and ipilimumab work in treating patients with poorly differentiated neuroendocrine tumors (i.e., neuroendocrine tumor that does not look like the normal tissue it arose from). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab and ipilimumab may shrink the cancer.

Primary Outcome

Participants who are considered to have a response are those with either a complete response (CR) (disappearance of all target lesions) or a partial response (PR) (\>=30% decrease in the sum of the longest diameter of target lesions) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 and assessed by CT or MRI scan.

Conditions Studied

Metastatic Neuroendocrine Carcinoma Metastatic Large-cell Neuroendocrine Carcinoma Metastatic Neuroendocrine Neoplasm Metastatic Small Cell Neuroendocrine Carcinoma

Interventions

  • DRUG Cabozantinib S-malate
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Study Locations (20)

Kansas

  • University of Kansas Clinical Research Center - Fairway
  • HaysMed - Hays
  • Lawrence Memorial Hospital - Lawrence
  • The University of Kansas Cancer Center - Olathe - Olathe
  • University of Kansas Cancer Center-Overland Park - Overland Park
  • Mercy Hospital Pittsburg - Pittsburg
  • Salina Regional Health Center - Salina
  • University of Kansas Health System Saint Francis Campus - Topeka

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange

Arizona

  • Banner University Medical Center - Tucson - Tucson
  • University of Arizona Cancer Center-North Campus - Tucson

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.
  • Sibley Memorial Hospital - Washington D.C.

Florida

  • UF Health Cancer Institute - Gainesville - Gainesville
  • Moffitt Cancer Center - Tampa

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2020-08-06
Est. Completion 2026-08-19
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT04079712 still lists

NCT04079712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).

The record links to 4 conditions, with Metastatic Neuroendocrine Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cabozantinib S-malate is the first listed.

NCT04079712 names 20 study sites across 7 states, led by Kansas, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT04079712 about?

NCT04079712 is a clinical study titled "Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors". This phase II trial studies how well the combination of XL184 (cabozantinib), nivolumab, and ipilimumab work in treating patients with poorly differentiated neuroendocrine tumors (i.e., neuroendocrine tumor that does not look like the normal tissue it arose from). Cabozantinib may stop the growth of...

What is the current status of trial NCT04079712?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2020-08-06. Estimated completion is 2026-08-19.

What conditions does trial NCT04079712 study?

This clinical trial studies the following conditions: Metastatic Neuroendocrine Carcinoma, Metastatic Large-cell Neuroendocrine Carcinoma, Metastatic Neuroendocrine Neoplasm, Metastatic Small Cell Neuroendocrine Carcinoma.

What interventions are being tested in trial NCT04079712?

The interventions under investigation include: Cabozantinib S-malate (DRUG), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04079712?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04079712 being conducted?

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

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Where NCT04079712's enrollment target sits among peer trials

17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT04079712, the US trial registry maintained by the National Library of Medicine. NCT04079712 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.