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

Advanced or Metastatic Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01928394
• Other study ID #: CA209-032
• Secondary ID: 2013-002844-10
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 24, 2013
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1163
• Est. completion date: October 31, 2024
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Subjects with histologically or cytologically confirmed locally advanced or metastatic

disease of the following tumor types:

• Triple Negative Breast Cancer
• Gastric Cancer
• Pancreatic Cancer
• Small Cell Lung Cancer
• Bladder Cancer
• Ovarian Cancer
• Subjects must have measurable disease
• Eastern Cooperative Oncology Group (ECOG) of 0 or 1
• Adequate hematological and organ function as confirmed by laboratory values

Exclusion Criteria:

• Active brain metastases or leptomeningeal metastases
• Subjects with active, known or suspected autoimmune disease
• Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
• Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting T cell is also prohibited

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Biological:
• Nivolumab

• Ipilimumab

Drug:
• Cobimetinib

Locations

Country	Name	City	State
Canada	Local Institution - 0038	Toronto	Ontario
Denmark	Local Institution - 0039	Copenhagen
Finland	Local Institution - 0014	Helsinki	Uusimaa
Finland	Local Institution - 0036	Tampere
Germany	Local Institution - 0048	Bonn
Germany	Local Institution - 0026	Frankfurt
Germany	Local Institution - 0016	Heidelberg
Germany	Local Institution - 0050	Kassel
Italy	Local Institution - 0024	Bologna
Italy	Local Institution - 0019	Milano
Italy	Local Institution - 0020	Napoli
Italy	Local Institution - 0032	Padova
Spain	Local Institution - 0037	Barcelona
Spain	Local Institution - 0010	Madrid
Spain	Local Institution - 0017	Madrid
Spain	Local Institution - 0023	Madrid
United Kingdom	Local Institution - 0012	Glasgow	Lanarkshire
United Kingdom	Local Institution - 0018	London	Greater London
United Kingdom	Local Institution - 0013	Sutton	Surrey
United States	Local Institution - 0001	Atlanta	Georgia
United States	Local Institution - 0044	Aurora	Colorado
United States	Local Institution - 0004	Baltimore	Maryland
United States	Local Institution - 0005	Boston	Massachusetts
United States	Local Institution - 0043	Boston	Massachusetts
United States	Local Institution - 0003	Charlotte	North Carolina
United States	Local Institution - 0008	Durham	North Carolina
United States	Local Institution - 0011	Franklin	Tennessee
United States	Local Institution - 0046	Gainesville	Florida
United States	Local Institution - 0009	Houston	Texas
United States	Local Institution - 0045	Mineola	New York
United States	Local Institution - 0047	Muscle Shoals	Alabama
United States	Local Institution - 0002	Nashville	Tennessee
United States	Local Institution - 0015	New Haven	Connecticut
United States	Local Institution - 0006	New York	New York
United States	Local Institution - 0049	Omaha	Nebraska
United States	Local Institution - 0007	Portland	Oregon
United States	Local Institution - 0042	Seattle	Washington
United States	Local Institution - 0021	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Finland,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate ( ORR )	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.	60 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting