Clinical trial NCT03048136: A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-02-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events
timeFrame: Approximately 3 months
measure: Incidence of high grade (Grade 3-4 and Grade 5) immune-mediated adverse events
timeFrame: Approximately 3 months
Secondary outcomes:
measure: Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
timeFrame: Up to 24 months
measure: Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
timeFrame: Up to 24 months
measure: Overall survival (OS) as defined as the time from first dosing to the date of death
timeFrame: Up to 5 years
measure: Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Lincoln
country: United States
facility: Local Institution
state: Nebraska
city: Hackensack
country: United States
facility: Local Institution
state: New Jersey
city: Columbus
country: United States
facility: Local Institution
state: Ohio
city: Lancaster
country: United States
facility: Local Institution
state: Pennsylvania
city: Langhorne
country: United States
facility: Local Institution
state: Pennsylvania
city: Sayre
country: United States
facility: Local Institution
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution
state: South Carolina
city: Saint George
country: United States
facility: Local Institution
state: Utah
city: Viedma
country: Argentina
facility: Local Institution
state: RIO Negro
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Dresden
country: Germany
facility: Local Institution
city: Gauting
country: Germany
facility: Local Institution
city: Gerlingen
country: Germany
facility: Local Institution
city: Grosshansdorf
country: Germany
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: