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NCT01928394 · ClinicalTrials.gov registry record · Phase 1
A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,163
- Enrollment target
- 20
- Study locations
NCT01928394: Completed Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Bristol-Myers Squibb.
NCT01928394 is a Phase 1 study of Advanced or Metastatic Solid Tumors that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,163 participants, above the 176-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (561% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928394, a Phase 1 study of Advanced or Metastatic Solid Tumors, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,163 participants
- Enrollment target
- 20
- Study locations
Study Summary
To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.
Primary Outcome
The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- DRUG Cobimetinib
Study Locations (20)
Florida
- Local Institution - 0046 - Gainesville
- Local Institution - 0021 - Tampa
Massachusetts
- Local Institution - 0005 - Boston
- Local Institution - 0043 - Boston
New York
- Local Institution - 0045 - Mineola
- Local Institution - 0006 - New York
North Carolina
- Local Institution - 0003 - Charlotte
- Local Institution - 0008 - Durham
Tennessee
- Local Institution - 0011 - Franklin
- Local Institution - 0002 - Nashville
Alabama
- Local Institution - 0047 - Muscle Shoals
Colorado
- Local Institution - 0044 - Aurora
Connecticut
- Local Institution - 0015 - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,163 participants |
| Start Date | 2013-10-24 |
| Est. Completion | 2024-11-18 |
| Phase | Phase 1 |
What the finished NCT01928394 record still lists
NCT01928394 is an interventional study that assigns participants to a tested intervention. Its 1,163 participants enrollment target places it among the larger protocols in the corpus, above the 176-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (561% higher).
The record links to 1 condition, with Advanced or Metastatic Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT01928394 names 20 study sites across 15 states, led by Florida, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT01928394 about?
NCT01928394 is a clinical study titled "A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors". To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combina...
What is the current status of trial NCT01928394?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,163 participants. The study started on 2013-10-24. Estimated completion is 2024-11-18.
What conditions does trial NCT01928394 study?
This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT01928394?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT01928394?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01928394 being conducted?
This trial has 20 study locations across Alabama, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01928394's enrollment target sits among peer trials
1,163 1st of 19 higher than 19 of 19 other Advanced or Metastatic Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced or Metastatic Solid Tumors 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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