A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03048136
• Other study ID #: CA209-955
• Status: Withdrawn
• Phase: Phase 3
• First received: February 8, 2017
• Last updated: April 13, 2018
• Start date: March 9, 2018
• Est. completion date: September 29, 2019

Study information

• Verified date: April 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 29, 2019
• Est. primary completion date: September 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Nivolumab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution	Viedma	RIO Negro
Canada	Local Institution	Montreal	Quebec
Germany	Local Institution	Dresden
Germany	Local Institution	Gauting
Germany	Local Institution	Gerlingen
Germany	Local Institution	Grosshansdorf
Peru	Local Institution	Lima
Peru	Local Institution	Lima
United States	Local Institution	Charleston	South Carolina
United States	Local Institution	Columbus	Ohio
United States	Local Institution	Hackensack	New Jersey
United States	Local Institution	Lancaster	Pennsylvania
United States	Local Institution	Langhorne	Pennsylvania
United States	Local Institution	Lincoln	Nebraska
United States	Local Institution	Saint George	Utah
United States	Local Institution	San Francisco	California
United States	Local Institution	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Germany,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events		Approximately 3 months
Primary	Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events		Approximately 3 months
Secondary	Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)		Up to 24 months
Secondary	Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)		Up to 24 months
Secondary	Overall survival (OS) as defined as the time from first dosing to the date of death		Up to 5 years
Secondary	Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)		Up to 24 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form