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A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer

  • Clinicaltrials.gov identifier

    NCT05005273

  • Recruitment Status

    Not yet recruiting

  • First Posted

    August 13, 2021

  • Last update posted

    April 15, 2022

Study Description

Brief summary:

The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).

  • Condition or Disease:Non-Small Cell Lung Cancer
  • Intervention/Treatment: Drug: Nivolumab
    Drug: Ipilimumab
    Drug: BMS-986207
    Other: Placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 212 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer
  • Estimated Study Start Date: August 2022
  • Estimated Primary Completion Date: April 2024
  • Estimated Study Completion Date: April 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1
Drug: Nivolumab
Specified dose on specified days

Drug: Ipilimumab
Specified dose on specified days

Drug: BMS-986207
Specified dose on specified days
Experimental: Part 2: Arm A
Drug: Nivolumab
Specified dose on specified days

Drug: Ipilimumab
Specified dose on specified days

Drug: BMS-986207
Specified dose on specified days
Experimental: Part 2: Arm B
Drug: Nivolumab
Specified dose on specified days

Drug: Ipilimumab
Specified dose on specified days

Other: Placebo
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of adverse events (AEs) meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 4 years ]
    Part 1
  • 2. Incidence of AEs [ Time Frame: Up to 4 years ]
    Part 1
  • 3. Incidence of treatment-related adverse events (TRAEs) [ Time Frame: Up to 4 years ]
    Part 1
  • 4. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 4 years ]
    Part 1
  • 5. Incidence of AEs leading to discontinuation [ Time Frame: Up to 4 years ]
    Part 1
  • 6. Incidence of deaths [ Time Frame: Up to 4 years ]
    Part 1
  • 7. Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR) [ Time Frame: Up to 25 months ]
    Part 2
  • Secondary Outcome Measures: 1. PFS based on RECIST v1.1 by BICR [ Time Frame: Up to 25 months ]
    Parts 1 & 2
  • 2. PFS based on RECIST v1.1 by Investigator's assessment [ Time Frame: Up to 25 months ]
    Parts 1 & 2
  • 3. Incidence of AEs [ Time Frame: Up to 4 years ]
    Part 2
  • 4. Incidence of SAEs [ Time Frame: Up to 4 years ]
    Part 2
  • 5. Incidence of AEs leading to discontinuation [ Time Frame: Up to 4 years ]
    Part 2
  • 6. Incidence of deaths [ Time Frame: Up to 4 years ]
    Part 2
  • 7. Objective response rate (ORR) based on RECIST v1.1 by BICR [ Time Frame: Up to 25 months ]
    Parts 1 & 2
  • 8. ORR based on RECIST v1.1 by Investigator's assessment [ Time Frame: Up to 25 months ]
    Parts 1 & 2
  • 9. Duration of Response (DOR) based on RECIST v1.1 by BICR [ Time Frame: Up to 25 months ]
    Parts 1 & 2
  • 10. DOR based on RECIST v1.1 by Investigator's assessment [ Time Frame: Up to 25 months ]
    Parts 1 & 2
  • 11. Overall Survival (OS) [ Time Frame: Up to 30 months ]
    Parts 1 & 2

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: Histologically confirmed metastatic 1L Stage IV non-small cell lung cancer (NSCLC) of squamous or nonsquamous histology No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Eastern Cooperative Oncology Group (ECOG) performance status 0-1 A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 20 unstained slides of tumor tissue obtained during screening or prior to enrollment Life expectancy of at least 3 months at the time of first dose Exclusion Criteria: Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutations which are sensitive to available targeted inhibitor therapy. Participants with nonsquamous histology and unknown EGFR, ALK, or ROS-1 status are also excluded Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible. Untreated central nervous system metastases Leptomeningeal metastases (carcinomatous meningitis) Concurrent malignancy requiring treatment Active, known, or suspected autoimmune disease Interstitial lung disease Uncontrolled or significant cardiovascular disease Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
Local Institution
Fountain Valley

United States, Florida
Local Institution
Fort Myers

United States, Florida
Local Institution
Gainesville

United States, Florida
Local Institution
Orange City

United States, Florida
Local Institution
Pensacola

United States, Florida
Local Institution
Port Saint Lucie

United States, Florida
Local Institution
Saint Petersburg

United States, Florida
Local Institution
Tallahassee

United States, Florida
Local Institution
West Palm Beach

United States, Idaho
Local Institution
Coeur d'Alene

United States, Kentucky
Local Institution
Edgewood

United States, Michigan
Local Institution
Ann Arbor

United States, New York
Local Institution
Brooklyn

United States, South Carolina
Local Institution
Charleston

United States, Wisconsin
Local Institution
Milwaukee

Argentina, Buenos Aires
Local Institution
Pergamino

Argentina, Santa FE
Local Institution
Rosario

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
San Juan

Australia, New South Wales
Local Institution
Orange

Australia, New South Wales
Local Institution
Wahroonga

Australia, Queensland
Local Institution
Douglas

Australia, Victoria
Local Institution
Warrnambool

Belgium
Local Institution
Charleroi

Belgium
Local Institution
Mechelen

Belgium
Local Institution
Mons

Belgium
Local Institution
Sint-Niklaas

Chile, Metropolitana
Local Institution
Santiago

Chile, Valparaiso
Local Institution
Vina del Mar

Chile, Valparaiso
Local Institution
Vina del Mar

France
Local Institution
Limoges

France
Local Institution
Nantes

France
Local Institution
Pessac

France
Local Institution
Rouen

France
Local Institution
Saint Priest en Jarez

France
Local Institution
Suresnes

France
Local Institution
Toulon

Germany
Local Institution
Frankfurt

Germany
Local Institution
Gauting

Germany
Local Institution
Gera

Germany
Local Institution
Mainz

Germany
Local Institution
Muenchen

Germany
Local Institution
Wiesbaden

Hungary
Local Institution
Torokbalint

Israel
Local Institution
Haifa

Israel
Local Institution
Jerusalem

Israel
Local Institution
Jerusalem

Italy
Local Institution
Bari

Italy
Local Institution
Bologna

Italy
Local Institution
Milano

Italy
Local Institution
Monza

Italy
Local Institution
Naples

Italy
Local Institution
Padova

Italy
Local Institution
Rozzano

Poland
Local Institution
Bydgoszcz

Poland
Local Institution
Lodz

Poland
Local Institution
Otwock

Poland
Local Institution
Szczecin

Spain
Local Institution
Alicante

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Local Institution
Jaen

Spain
Local Institution
Madrid

Spain
Local Institution
Majadahonda

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Istanbul

Turkey
Local Institution
Izmir

Turkey
Local Institution
Samsun

Turkey
Local Institution
Yuregir

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05005273 History of Changes
  • Other Study ID Numbers: CA020-016, 2021-000039-29, U1111-1263-4850
  • First Posted: August 13, 2021 Key Record Dates
  • Last Update Posted: April 15, 2022
  • Last Verified: April 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Non-Small Cell Lung Cancer
    NSCLC
    BMS-986207
    Nivolumab
    Opdivo
    Ipilimumab
    Yervoy
  • Additional relevant MeSH terms: Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Respiratory Tract Neoplasms
    Thoracic Neoplasms
    Neoplasms by Site
    Neoplasms
    Lung Diseases
    Respiratory Tract Diseases
    Carcinoma, Bronchogenic
    Bronchial Neoplasms