NCT01928394

A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors

A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,163 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All tumor types are now closed for enrollment: Triple Negative Breast Cancer Gastric Cancer Pancreatic Cancer Small Cell Lung Cancer Bladder Cancer Ovarian Cancer

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab
BIOLOGICAL	Ipilimumab
DRUG	Cobimetinib

Timeline

• Start date: 2013-10-24
• Primary completion: 2019-02-05
• Completion: 2024-11-18
• First posted: 2013-08-23
• Last updated: 2024-12-27
• Results posted: 2020-03-24

Locations

38 sites across 8 countries: United States, Canada, Denmark, Finland, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study