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)

NCT03001882 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CA209-5922018-000462-11
• Study Type: interventional
• Target: 230
• Locations: 8 countries
• Sites: 35

Brief Summary

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).

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB)

  Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \<10 mm. Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum. CR+PR, confidence interval based on the Clopper and Pearson method.

  From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)

• Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (Blood TMB Cut-point = 21-mutations/MB)

  Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \<10 mm. Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum. CR+PR, confidence interval based on the Clopper and Pearson method.

  From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)

• Objective Response Rate (ORR) Per Investigator by Tissue TMB Within PD-L1 Subgroup (Tissue TMB Cut-point = 10-mutations/MB)

  Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to \<10 mm. Tissue tumor mutational burden (tTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in tumor tissue samples. CR+PR, confidence interval based on the Clopper and Pearson method.

  From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)

Secondary Outcomes (9)

• Objective Response Rate (ORR) for All Treated Participants by Investigator Per RECIST 1.1

  From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)

• Disease Control Rate (DCR) for Part 1

  From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)

• Duration of Response (DOR) for Part 1

  From first dose to the date of the first documented tumor progression or death due to any cause (Up to approximately 67 months)

• Time to Response (TTR) for Part 1

  From first dose to the time the criteria for Complete Response/Partial Response are first met (Up to approximately 67 months)

• Progression Free Survival (PFS)

  From first dose to the date of the first documented tumor progression or death due to any causes (Assessed up to approximately 67 months)

Study Arms (1)

Combination therapy

EXPERIMENTAL

Nivolumab + Ipilimumab

Biological: Nivolumab; Biological: Ipilimumab

Interventions

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Combination therapy

Ipilimumab BIOLOGICAL

Specified dose on specified days

Also known as: Yervoy, BMS-734016

Combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Yale University: collaborator

Study Sites (35)

Local Institution - 0006

Springdale, Arkansas, 72762, United States

Location

Local Institution - 0001

New Haven, Connecticut, 06520, United States

Location

Local Institution - 0005

Jacksonville, Florida, 32256, United States

Location

Local Institution - 0009

Atlanta, Georgia, 30322, United States

Location

Local Institution - 0003

St Louis, Missouri, 63110, United States

Location

Local Institution - 0038

The Bronx, New York, 10461, United States

Location

Local Institution - 0002

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0008

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0007

Greenville, South Carolina, 29607, United States

Location

Local Institution - 0004

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0017

La Louvière, Hainaut, 7100, Belgium

Location

Local Institution - 0018

Ghent, 9000, Belgium

Location

Local Institution - 0028

Ghent, 9000, Belgium

Location

Local Institution - 0027

Liège, 4000, Belgium

Location

Local Institution - 0016

Sint-Niklaas, 9100, Belgium

Location

Local Institution - 0036

Paris, 75248, France

Location

Local Institution - 0033

Pierre-Bénite, 69495, France

Location

Local Institution - 0034

Strasbourg, 67091, France

Location

Local Institution - 0039

Toulon, 83000, France

Location

Local Institution - 0015

Essen, 45136, Germany

Location

Local Institution - 0014

Immenstadt im Allgäu, 87509, Germany

Location

Local Institution - 0013

Löwenstein, 74245, Germany

Location

Local Institution - 0012

Stuttgart, 70174, Germany

Location

Local Institution - 0023

Bergamo, 24127, Italy

Location

Local Institution - 0025

Catania, 95123, Italy

Location

Local Institution - 0026

Parma, 43100, Italy

Location

Local Institution - 0024

Perugia, 06129, Italy

Location

Local Institution - 0021

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 0022

Nijmegen, 6525 GA, Netherlands

Location

Local Institution - 0011

Cluj-Napoca, Cluj, 400015, Romania

Location

Local Institution - 0010

Craiova, 200542, Romania

Location

Local Institution - 0031

Barcelona, 08908, Spain

Location

Local Institution - 0029

Madrid, 28041, Spain

Location

Local Institution - 0030

Madrid, 28046, Spain

Location

Local Institution - 0032

Seville, 41009, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 23, 2016
• Study Start: March 29, 2017
• Primary Completion: February 17, 2022
• Study Completion: April 24, 2023
• Last Updated: May 20, 2024
• Results First Posted: June 6, 2023

Record last verified: 2024-04

Locations

BE (5); IT (4); NL (2); RO (2); US (10); ES (4); FR (4); DE (4)