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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: Recruiting Phase 2 study of Chromophobe Renal Cell Carcinoma and Bladder Small Cell Neuroendocrine Carcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An objective response is defined as a confirmed complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Will be estimated by the number of confirmed objective responses divided by the total number of evaluable patients. Confidence intervals for the true ORR will be calculated.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2019-05-13 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 2 |
What NCT03866382 shows while recruiting
NCT03866382 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, above the 194-participant average among 8 other Chromophobe Renal Cell Carcinoma trials with a reported enrollment target (62% higher).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Where NCT03866382's enrollment target sits among peer trials
314 3rd of 8 higher than 6 of 8 other Chromophobe Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chromophobe Renal Cell Carcinoma 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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