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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: Active Phase 1 study of Malignant Solid Neoplasm and Clear Cell Renal Cell Carcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be defined as the highest dose for which no more than 1/6 patients experience a dose limiting toxicity evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The safe dose level of cabozantinib and nivolumab, as well as of cabozantinib, nivolumab, and ipilimumab will be established.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2015-07-22 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
What the registry record for NCT02496208 still lists
NCT02496208 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (87% lower).
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 lists 8 locations in 4 states (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.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
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 NCT02496208's enrollment target sits among peer trials
152 75th of 176 higher than 102 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm 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.
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