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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 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.

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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.

Conditions Studied

Advanced or Metastatic Solid Tumors

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

FieldValue
Enrollment Target 1,163 participants
Start Date 2013-10-24
Est. Completion 2024-11-18
Phase Phase 1

Sponsor

Bristol-Myers Squibb

1,025 total trials

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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, categorized as Phase 1. The registered enrollment target is 1,163 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 176-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (561% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.