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NCT02496208 · ClinicalTrials.gov registry record · Phase 1

Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors

A Phase 1 study of Malignant Solid Neoplasm and Clear Cell Renal Cell Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
152
Enrollment target
8
Study locations

NCT02496208 is a Phase 1 study of Malignant Solid Neoplasm and Clear Cell Renal Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 152 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (87% lower). The trial reports 8 study locations across 4 states.

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The verdict

NCT02496208, a Phase 1 study of Malignant Solid Neoplasm and Clear Cell Renal Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
152 participants
Enrollment target
8
Study locations

Study Summary

This phase I trial studies the side effects and best doses of cabozantinib s-malate and nivolumab with or without ipilimumab in treating patients with genitourinary (genital and urinary organ) tumors that have spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib s-malate 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. It is not yet known whether giving cabozantinib s-malate and nivolumab alone or with ipilimumab works better in treating patients with genitourinary tumors.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy Procedure
  • DRUG Cabozantinib S-malate
  • PROCEDURE Echocardiography Test

Study Locations (8)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • University of California Davis Comprehensive Cancer Center - Sacramento

Maryland

  • National Institutes of Health Clinical Center - Bethesda
  • NCI - Center for Cancer Research - Bethesda

New Jersey

  • Rutgers Cancer Institute of New Jersey - New Brunswick

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2015-07-22
Est. Completion 2026-09-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT02496208

The ClinicalTrials.gov registry entry for NCT02496208 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (87% lower). 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 Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT02496208 reports 8 study locations spanning 4 distinct geographic areas - top geographies include California, Maryland, New Jersey.

Frequently Asked Questions

What is clinical trial NCT02496208 about?

NCT02496208 is a clinical study titled "Cabozantinib S-malate and Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Genitourinary Tumors". This phase I trial studies the side effects and best doses of cabozantinib s-malate and nivolumab with or without ipilimumab in treating patients with genitourinary (genital and urinary organ) tumors that have spread from where it first started (primary site) to other places in the body (metastatic)...

What is the current status of trial NCT02496208?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 152 participants. The study started on 2015-07-22. Estimated completion is 2026-09-30.

What conditions does trial NCT02496208 study?

This clinical trial studies the following conditions: Malignant Solid Neoplasm, Clear Cell Renal Cell Carcinoma, Bladder Urothelial Carcinoma, Malignant Genitourinary System Neoplasm, Bladder Small Cell Neuroendocrine Carcinoma.

What interventions are being tested in trial NCT02496208?

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

Who is sponsoring clinical trial NCT02496208?

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

Where is trial NCT02496208 being conducted?

This trial has 8 study locations across California, Maryland, New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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