Clinical Trial: NCT03001882 - My Cancer Genome

NCT03001882

Description:

The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03001882

Trial Eligibility

Document

Title

Brief Title: An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Official Title: An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

ORG STUDY ID: CA209-592
SECONDARY ID: 2018-000462-11
NCT ID: NCT03001882

Conditions

Non-Small Cell Lung Cancer

Interventions

Drug	Synonyms	Arms
Nivolumab	Opdivo, BMS-936558	Combination therapy
Ipilimumab	Yervoy, BMS-734016	Combination therapy

Purpose

Trial Arms

Name	Type	Description	Interventions
Combination therapy	Experimental	Nivolumab + Ipilimumab	Nivolumab Ipilimumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no
             prior systemic anticancer therapy given as primary therapy for advanced or metastatic
             disease

          -  Measurable disease by CT or MRI

          -  Must have full activity or, if limited, must be able to walk and carry out light
             activities such as light house work or office work

        Exclusion Criteria:

          -  Participants with untreated central nervous system metastases

          -  Participants with active, known or suspected autoimmune disease

          -  Prior treatment with any drug that targets T cell co-stimulations pathways (such as
             checkpoint inhibitors)

        Other protocol defined inclusion/exclusion criteria could apply

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Objective Response Rate (ORR) of patient subgroups defined by baseline biomarkers
Time Frame:	Approximately 48 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	Objective Response Rate (ORR)
Time Frame:	Approximately 48 months
Safety Issue:
Description:

Measure:	Disease Control Rate (DCR) of patient subgroups defined by baseline biomarkers
Time Frame:	Approximately 48 months
Safety Issue:
Description:

Measure:	Duration of Response (DOR) of patient subgroups defined by baseline biomarkers
Time Frame:	Approximately 48 months
Safety Issue:
Description:

Measure:	Time to Response (TTR) of patient subgroups defined by baseline biomarkers
Time Frame:	Approximately 48 months
Safety Issue:
Description:

Measure:	Progression Free Survival (PFS) of patient subgroups defined by baseline biomarkers
Time Frame:	Approximately 48 months
Safety Issue:
Description:

Measure:	Overall Survival (OS) of patient subgroups defined by baseline biomarkers
Time Frame:	Approximately 48 months
Safety Issue:
Description:

Measure:	Incidence of Adverse Events (AEs)
Time Frame:	Approximately 48 months
Safety Issue:
Description:

Measure:	Incidence of Serious Adverse Events (SAEs)
Time Frame:	Approximately 48 months
Safety Issue:
Description:

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Bristol-Myers Squibb

Last Updated

August 20, 2021

Clinical Trials /

An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)