A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer (CheckMate 955)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Ipilimumab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 1) Stage IV or recurrent non-Small cell lung cancer
- 2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- 3) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization
Exclusion Criteria:
- 1) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
- 2) Active, known or suspected autoimmune disease or HIV infection
- 3) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
- 4) Untreated Central Nervous System metastases
Other protocol defined inclusion/exclusion criteria could apply
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Flat-Dose
Weight-Based Dose
Arm Description
Nivolumab flat dose + Ipilimumab
Nivolumab weight-based dose + Ipilimumab
Outcomes
Primary Outcome Measures
Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events
Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events
Secondary Outcome Measures
Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Overall survival (OS) as defined as the time from first dosing to the date of death
Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03048136
Brief Title
A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
Acronym
CheckMate 955
Official Title
A Phase Ib/II Safety Trial of Nivolumab in Combination With Ipilimumab Administered in Participants With Chemotherapy-naive Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (CheckMate 955: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 955)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Business objective has changed
Study Start Date
March 9, 2018 (Anticipated)
Primary Completion Date
September 29, 2019 (Anticipated)
Study Completion Date
September 29, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
Detailed Description
A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flat-Dose
Arm Type
Experimental
Arm Description
Nivolumab flat dose + Ipilimumab
Arm Title
Weight-Based Dose
Arm Type
Experimental
Arm Description
Nivolumab weight-based dose + Ipilimumab
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, Yervoy
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events
Time Frame
Approximately 3 months
Title
Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events
Time Frame
Approximately 3 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame
Up to 24 months
Title
Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame
Up to 24 months
Title
Overall survival (OS) as defined as the time from first dosing to the date of death
Time Frame
Up to 5 years
Title
Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
1) Stage IV or recurrent non-Small cell lung cancer
2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
3) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization
Exclusion Criteria:
1) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
2) Active, known or suspected autoimmune disease or HIV infection
3) Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
4) Untreated Central Nervous System metastases
Other protocol defined inclusion/exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Local Institution
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Local Institution
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Local Institution
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Local Institution
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Local Institution
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Local Institution
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Local Institution
City
Viedma
State/Province
RIO Negro
ZIP/Postal Code
8500
Country
Argentina
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Local Institution
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Local Institution
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Local Institution
City
Lima
Country
Peru
12. IPD Sharing Statement
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
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