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

NCT05005273 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CA020-0162021-000039-29U1111-1263-4850
• Study Type: interventional
• Target: 1
• Locations: 12 countries
• Sites: 71

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).

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; NSCLC; BMS-986207; Nivolumab; Opdivo; Ipilimumab; Yervoy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival by BICR

  PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

  From first dose to progression or death, 2.3 months

Secondary Outcomes (6)

• Progression Free Survival by Investigator

  From first dose to progression or death, 2.3 months

• Overall Response Rate (ORR) by BICR

  From first dose to progression or death, 2.3 months

• Overall Response Rate (ORR) by Investigator

  From first dose to progression or death, 2.3 months

• Duration of Response (DOR) by Investigator

  From first dose to progression or death, 2.3 months

• Overall Survival (OS)

  From randomization to time of death, 2.3 months

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Nivolumab; Drug: Ipilimumab; Drug: BMS-986207

Arm B

EXPERIMENTAL

Drug: Nivolumab; Drug: Ipilimumab; Other: Placebo

Interventions

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo, BMS-963558

Arm A; Arm B

Ipilimumab DRUG

Specified dose on specified days

Also known as: Yervoy, BMS-734016

Arm A; Arm B

BMS-986207 DRUG

Specified dose on specified days

Arm A

Placebo OTHER

Specified dose on specified days

Arm B

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (71)

Local Institution - 0080

Tucson, Arizona, 85719, United States

Location

Local Institution - 0051

Fountain Valley, California, 92708, United States

Location

Local Institution - 0070

Fort Myers, Florida, 33901, United States

Location

Local Institution - 0073

Gainesville, Florida, 32610, United States

Location

Local Institution - 0036

Orange City, Florida, 32763, United States

Location

Local Institution - 0045

Pensacola, Florida, 32504, United States

Location

Local Institution

Port Saint Lucie, Florida, 34952, United States

Location

Local Institution - 0068

St. Petersburg, Florida, 33705, United States

Location

Local Institution

Tallahassee, Florida, 32308, United States

Location

Local Institution

West Palm Beach, Florida, 33401, United States

Location

Local Institution - 0081

Boise, Idaho, 83706, United States

Location

Local Institution - 0077

Coeur d'Alene, Idaho, 83214, United States

Location

Local Institution - 0074

Edgewood, Kentucky, 41017, United States

Location

Local Institution - 0002

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0049

Brooklyn, New York, 11220, United States

Location

Local Institution - 0012

Charleston, South Carolina, 29414, United States

Location

Local Institution - 0053

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution - 0009

Pergamino, Buenos Aires, 2700, Argentina

Location

Local Institution - 0054

Rosario, Santa Fe Province, S2000DEJ, Argentina

Location

Local Institution - 0062

Buenos Aires, 1061, Argentina

Location

Local Institution - 0021

Buenos Aires, 1125, Argentina

Location

Local Institution - 0011

Buenos Aires, 1280, Argentina

Location

Local Institution - 0048

Buenos Aires, C1122, Argentina

Location

Local Institution - 0057

San Juan, 5400, Argentina

Location

Local Institution - 0063

Orange, New South Wales, 2800, Australia

Location

Local Institution - 0056

Wahroonga, New South Wales, 0, Australia

Location

Local Institution - 0052

Warrnambool, Victoria, 3280, Australia

Location

Local Institution - 0034

Mechelen, Antwerpen, 2800, Belgium

Location

Local Institution - 0040

Charleroi, 6000, Belgium

Location

Local Institution - 0043

Mons, 7000, Belgium

Location

Local Institution - 0019

Sint-Niklaas, 9100, Belgium

Location

Local Institution - 0035

Viña del Mar, Región de Valparaíso, 2520000, Chile

Location

Local Institution - 0015

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Local Institution - 0050

Santiago, Santiago Metropolitan, 8320000, Chile

Location

Local Institution - 0037

Limoges, 87042, France

Location

Local Institution - 0030

Nantes, 44093, France

Location

Local Institution - 0044

Pessac, 33604, France

Location

Local Institution - 0016

Rouen, 76000, France

Location

Local Institution - 0031

Saint-Priest-en-Jarez, 42271, France

Location

Local Institution - 0013

Suresnes, 92150, France

Location

Local Institution - 0042

Toulon, 83056, France

Location

Local Institution - 0005

Gauting, Bavaria, 82131, Germany

Location

Local Institution - 0022

Frankfurt am Main, Hesse, 60590, Germany

Location

Local Institution - 0017

Gera, 7548, Germany

Location

Local Institution - 0023

München, 81925, Germany

Location

Local Institution - 0059

Wiesbaden, 65199, Germany

Location

Local Institution - 0064

Haifa, 3339419, Israel

Location

Local Institution - 0061

Jerusalem, 9103102, Israel

Location

Local Institution - 0078

Jerusalem, 91200, Israel

Location

Local Institution - 0079

Jerusalem, 91200, Israel

Location

Local Institution - 0039

Monza, MB, 20900, Italy

Location

Local Institution - 0020

Rozzano, MI, 20089, Italy

Location

Local Institution

Milan, 20133, Italy

Location

Local Institution - 0028

Naples, 80131, Italy

Location

Local Institution - 0001

Padua, 35128, Italy

Location

Local Institution - 0024

Bydgoszcz, 85-796, Poland

Location

Local Institution - 0003

Lodz, 93-338, Poland

Location

Local Institution - 0038

Otwock, 05-400, Poland

Location

Local Institution - 0058

Szczecin, 70-452, Poland

Location

Local Institution - 0033

Majadahonda, Madrid, 28220, Spain

Location

Local Institution - 0041

Alicante, 3010, Spain

Location

Local Institution - 0026

Barcelona, 08017, Spain

Location

Local Institution - 0075

Barcelona, 08028, Spain

Location

Local Institution - 0006

Barcelona, 08908, Spain

Location

Local Institution - 0046

Jaén, 23007, Spain

Location

Local Institution - 0032

Madrid, 28040, Spain

Location

Local Institution - 0076

Istanbul, 34010, Turkey (Türkiye)

Location

Local Institution - 0066

Istanbul, 34098, Turkey (Türkiye)

Location

Local Institution - 0065

Izmir, 35575, Turkey (Türkiye)

Location

Local Institution - 0067

Samsun, 55200, Turkey (Türkiye)

Location

Local Institution - 0072

Yüreğir, 01250, Turkey (Türkiye)

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• 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

Limitations and Caveats

Due to 1 participant being randomized and treated sub group analysis were not completed for this study.

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 13, 2021
• Study Start: October 3, 2022
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

IT (5); BE (4); DE (5); PL (4); IL (4); AR (7); CL (3); TU (5); AU (3); ES (7); FR (7); US (17)