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NCT03117309 · ClinicalTrials.gov registry record · Phase 2
Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma
A Phase 2 study of Advanced Renal Cell Carcinoma, sponsored by Michael B. Atkins, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 164
- Enrollment target
- 12
- Study locations
NCT03117309: Completed Phase 2 study of Advanced Renal Cell Carcinoma, sponsored by Michael B. Atkins, MD.
NCT03117309 is a Phase 2 study of Advanced Renal Cell Carcinoma that has completed, run by Michael B. Atkins, MD. The registered enrollment target is 164 participants, above the 80-participant average among 12 other Advanced Renal Cell Carcinoma trials with a reported enrollment target (105% higher). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03117309, a Phase 2 study of Advanced Renal Cell Carcinoma, has completed, sponsored by Michael B. Atkins, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 164 participants
- Enrollment target
- 12
- Study locations
Study Summary
Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. 1-year Progression-Free Survival (PFS) Rate refers to the percentage of patients who have not experien
Conditions Studied
Interventions
- DRUG Nivolumab 240 mg
- DRUG Ipilimumab 1mg/kg
- DRUG Nivolumab 3mg/kg
- DRUG Nivolumab 360mg
Study Locations (12)
Illinois
- Northwestern University Feinberg Schooll Of Medicine - Chicago
- University of Illinois Cancer Center - Chicago
Pennsylvania
- Univeristy of Pennsylvania - Philadelphia
- Fox Chase Cancer Center - Philadelphia
Connecticut
- Yale University, Yale Cancer Center - New Haven
District of Columbia
- Georgetown University - Washington D.C.
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Massachusetts
- Beth Isreal Deaconess Medical Center - Boston
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Columbia University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2017-04-24 |
| Est. Completion | 2025-01-23 |
| Phase | Phase 2 |
What the finished NCT03117309 record still lists
NCT03117309 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 12 other Advanced Renal Cell Carcinoma trials with a reported enrollment target (105% higher).
The record links to 1 condition, with Advanced Renal Cell Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab 240 mg is the first listed.
NCT03117309 lists 12 locations in 10 states (Illinois, Pennsylvania, Connecticut).
Frequently Asked Questions
What is clinical trial NCT03117309 about?
NCT03117309 is a clinical study titled "Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma". Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.
What is the current status of trial NCT03117309?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2017-04-24. Estimated completion is 2025-01-23.
What conditions does trial NCT03117309 study?
This clinical trial studies the following conditions: Advanced Renal Cell Carcinoma.
What interventions are being tested in trial NCT03117309?
The interventions under investigation include: Nivolumab 240 mg (DRUG), Ipilimumab 1mg/kg (DRUG), Nivolumab 3mg/kg (DRUG), Nivolumab 360mg (DRUG).
Who is sponsoring clinical trial NCT03117309?
This trial is sponsored by Michael B. Atkins, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03117309 being conducted?
This trial has 12 study locations across Connecticut, District of Columbia, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03117309's enrollment target sits among peer trials
164 2nd of 12 the highest of 12 other Advanced Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced 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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