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NCT02187302 · ClinicalTrials.gov registry record · Phase 2
CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)
A Phase 2 study of Metastatic Renal Cell Carcinoma, sponsored by NewLink Genetics Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
- 20
- Study locations
NCT02187302: Completed Phase 2 study of Metastatic Renal Cell Carcinoma, sponsored by NewLink Genetics Corporation.
NCT02187302 is a Phase 2 study of Metastatic Renal Cell Carcinoma that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 115 participants, below the 140-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02187302, a Phase 2 study of Metastatic Renal Cell Carcinoma, has completed, sponsored by NewLink Genetics Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101 in combination with bevacizumab compared to treatment with a standard of care therapy. The study will compare which treatment resulted in longer time before progression of the RCC. Patients will be treated and followed for progression of their disease on average for up to 6 months.
Primary Outcome
To assess progression free survival (PFS) in patients with clear cell metastatic renal cell carcinoma (RCC) treated with CRLX101 in combination with bevacizumab (CRLX101+bevacizumab) vs. standard of care (SOC) per investigator's choice, as assessed by blinded independent radiological review (IRR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG CRLX101
- DRUG Standard of Care (Investigator Choice)
Study Locations (20)
California
- University of California San Diego - La Jolla
- David Geffen School of Medicine UCLA - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
Indiana
- Indiana University School of Medicine - Indianapolis
- Franciscan St. Francis Health - Indianapolis
Kansas
- The University of Kansas Cancer Center - Fairway
- Cancer Center of Kansas - Wichita
Michigan
- Ann Arbor Hematoloty-Oncology - Ann Arbor
- Karmanos Cancer Institute - Detroit
Colorado
- Rocky Mountain Cancer Centers - Denver
Georgia
- Emory University - Atlanta
Hawaii
- Kaiser Permanente - Honolulu
Illinois
- Decatur Memorial Hospital - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2014-07 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
What the finished NCT02187302 record still lists
NCT02187302 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 140-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Metastatic Renal Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Bevacizumab is the first listed.
NCT02187302 names 20 study sites across 15 states, led by California, Indiana, Kansas.
Frequently Asked Questions
What is clinical trial NCT02187302 about?
NCT02187302 is a clinical study titled "CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)". This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101 in combination with bevacizumab compared to treatment with a standard of care therapy. The study will compare whic...
What is the current status of trial NCT02187302?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2014-07. Estimated completion is 2017-01.
What conditions does trial NCT02187302 study?
This clinical trial studies the following conditions: Metastatic Renal Cell Carcinoma.
What interventions are being tested in trial NCT02187302?
The interventions under investigation include: Bevacizumab (DRUG), CRLX101 (DRUG), Standard of Care (Investigator Choice) (DRUG).
Who is sponsoring clinical trial NCT02187302?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02187302 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02187302's enrollment target sits among peer trials
115 13th of 37 higher than 25 of 37 other Metastatic Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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