Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
NCT01928394 · View on ClinicalTrials.gov ↗
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.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01928394
The ClinicalTrials.gov registry entry for NCT01928394 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,163 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01928394 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Florida, Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01928394?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Cobimetinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01928394?
This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.