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NCT03914300 · ClinicalTrials.gov registry record · Phase 2

Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer

A Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Thyroid Gland Papillary Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
11
Enrollment target
20
Study locations

NCT03914300: Active Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Thyroid Gland Papillary Carcinoma, sponsored by National Cancer Institute (NCI).

NCT03914300 is a Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Thyroid Gland Papillary Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 31-participant average among 6 other Poorly Differentiated Thyroid Gland Carcinoma trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03914300, a Phase 2 study of Poorly Differentiated Thyroid Gland Carcinoma and Thyroid Gland Papillary Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

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

Study Summary

This phase II trial studies how well cabozantinib, nivolumab, and ipilimumab work in treating patients with differentiated thyroid cancer that does not respond to radioactive iodine and that worsened after treatment with a drug targeting the vascular endothelial growth factor receptor (VEGFR), a protein needed to form blood vessels. 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 work better than the usual approach consisting of chemotherapy with drugs such as doxorubicin, sorafenib, and lenvatinib for this type of thyroid cancer.

Primary Outcome

Defined as the proportion of patients who have had a partial response (PR) or complete response (CR) within the first 6 months after initiation of therapy.

Conditions Studied

Poorly Differentiated Thyroid Gland Carcinoma Thyroid Gland Papillary Carcinoma Refractory Thyroid Gland Carcinoma Thyroid Gland Follicular Carcinoma Differentiated Thyroid Gland Carcinoma Refractory Differentiated Thyroid Gland Carcinoma Thyroid Gland Oncocytic Carcinoma Follicular Variant Thyroid Gland Papillary Carcinoma Tall Cell Variant Thyroid Gland Papillary Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • DRUG Cabozantinib S-malate
  • BIOLOGICAL Ipilimumab

Study Locations (20)

Kansas

  • University of Kansas Clinical Research Center - Fairway
  • HaysMed - Hays
  • University of Kansas Cancer Center - Kansas City
  • 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
  • University of Kansas Hospital-Westwood Cancer Center - Westwood

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • USC Norris Oncology/Hematology-Newport Beach - Newport Beach

Florida

  • Moffitt Cancer Center-International Plaza - Tampa
  • Moffitt Cancer Center - McKinley Campus - Tampa
  • Moffitt Cancer Center - Tampa

Missouri

  • University Health Truman Medical Center - Kansas City
  • University of Kansas Cancer Center - North - Kansas City

Kentucky

  • University of Kentucky/Markey Cancer Center - Lexington

Minnesota

  • Mayo Clinic in Rochester - Rochester

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2020-02-10
Est. Completion 2026-12-17
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT03914300 still lists

NCT03914300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 31-participant average among 6 other Poorly Differentiated Thyroid Gland Carcinoma trials with a reported enrollment target (65% lower).

The record links to 9 conditions, with Poorly Differentiated Thyroid Gland Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT03914300 names 20 study sites across 6 states, led by Kansas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT03914300 about?

NCT03914300 is a clinical study titled "Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer". This phase II trial studies how well cabozantinib, nivolumab, and ipilimumab work in treating patients with differentiated thyroid cancer that does not respond to radioactive iodine and that worsened after treatment with a drug targeting the vascular endothelial growth factor receptor (VEGFR), a pro...

What is the current status of trial NCT03914300?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2020-02-10. Estimated completion is 2026-12-17.

What conditions does trial NCT03914300 study?

This clinical trial studies the following conditions: Poorly Differentiated Thyroid Gland Carcinoma, Thyroid Gland Papillary Carcinoma, Refractory Thyroid Gland Carcinoma, Thyroid Gland Follicular Carcinoma, Differentiated Thyroid Gland Carcinoma.

What interventions are being tested in trial NCT03914300?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cabozantinib S-malate (DRUG), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03914300?

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

Where is trial NCT03914300 being conducted?

This trial has 20 study locations across California, Florida, Kansas, Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT03914300, the US trial registry maintained by the National Library of Medicine. NCT03914300 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.