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NCT03866382 · ClinicalTrials.gov registry record · Phase 2

Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

A Phase 2 study of Chromophobe Renal Cell Carcinoma and Bladder Small Cell Neuroendocrine Carcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
314
Enrollment target
20
Study locations

NCT03866382 is a Phase 2 study of Chromophobe Renal Cell Carcinoma and Bladder Small Cell Neuroendocrine Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 314 participants, above the 194-participant average among 8 other Chromophobe Renal Cell Carcinoma trials with a reported enrollment target (62% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT03866382, a Phase 2 study of Chromophobe Renal Cell Carcinoma and Bladder Small Cell Neuroendocrine Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
314 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. 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 in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

Conditions Studied

Chromophobe Renal Cell Carcinoma Bladder Small Cell Neuroendocrine Carcinoma Bladder Squamous Cell Carcinoma Collecting Duct Carcinoma Bladder Adenocarcinoma Bladder Clear Cell Adenocarcinoma Bladder Mixed Adenocarcinoma Bladder Neuroendocrine Carcinoma Invasive Bladder Giant Cell Urothelial Carcinoma Invasive Bladder Lymphoepithelioma-Like Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Bone Scan
  • DRUG Cabozantinib S-malate
  • PROCEDURE Echocardiography Test

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Anchorage Radiation Therapy Center - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage

Arizona

  • Kingman Regional Medical Center - Kingman
  • Cancer Center at Saint Joseph's - Phoenix
  • Mayo Clinic Hospital in Arizona - Phoenix
  • Mayo Clinic in Arizona - Scottsdale
  • University of Arizona Cancer Center-Orange Grove Campus - Tucson
  • Banner University Medical Center - Tucson - Tucson
  • University of Arizona Cancer Center-North Campus - Tucson

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith
  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs

California

  • Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
  • PCR Oncology - Arroyo Grande

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Trial Details

FieldValue
Enrollment Target 314 participants
Start Date 2019-05-13
Est. Completion 2027-02-28
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03866382

The ClinicalTrials.gov registry entry for NCT03866382 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 194-participant average among 8 other Chromophobe Renal Cell Carcinoma trials with a reported enrollment target (62% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Chromophobe Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT03866382 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, Arizona, Arkansas.

Frequently Asked Questions

What is clinical trial NCT03866382 about?

NCT03866382 is a clinical study titled "Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors". This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blo...

What is the current status of trial NCT03866382?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 314 participants. The study started on 2019-05-13. Estimated completion is 2027-02-28.

What conditions does trial NCT03866382 study?

This clinical trial studies the following conditions: Chromophobe Renal Cell Carcinoma, Bladder Small Cell Neuroendocrine Carcinoma, Bladder Squamous Cell Carcinoma, Collecting Duct Carcinoma, Bladder Adenocarcinoma.

What interventions are being tested in trial NCT03866382?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Cabozantinib S-malate (DRUG), Echocardiography Test (PROCEDURE).

Who is sponsoring clinical trial NCT03866382?

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

Where is trial NCT03866382 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.