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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 2 Randomized Study of BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005273
• Other study ID #: CA020-016
• Secondary ID: 2021-000039-29U1
• Status: Completed
• Phase: Phase 2
• Start date: October 3, 2022
• Est. completion date: December 27, 2022

Study information

• Verified date: January 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Nivolumab
Specified dose on specified days
• Ipilimumab
Specified dose on specified days
• BMS-986207
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0011	Buenos Aires
Argentina	Local Institution - 0021	Buenos Aires
Argentina	Local Institution - 0048	Buenos Aires
Argentina	Local Institution - 0062	Buenos Aires
Argentina	Local Institution - 0009	Pergamino	Buenos Aires
Argentina	Local Institution - 0054	Rosario	Santa FE
Argentina	Local Institution - 0057	San Juan
Australia	Local Institution - 0063	Orange	New South Wales
Australia	Local Institution - 0056	Wahroonga	New South Wales
Australia	Local Institution - 0052	Warrnambool	Victoria
Belgium	Local Institution - 0040	Charleroi
Belgium	Local Institution - 0034	Mechelen	Antwerpen
Belgium	Local Institution - 0043	Mons
Belgium	Local Institution - 0019	Sint-Niklaas
Chile	Local Institution - 0050	Santiago	Metropolitana
Chile	Local Institution - 0015	Vina del Mar	Valparaiso
Chile	Local Institution - 0035	Vina del Mar	Valparaiso
France	Local Institution - 0037	Limoges
France	Local Institution - 0030	Nantes
France	Local Institution - 0044	Pessac
France	Local Institution - 0016	Rouen
France	Local Institution - 0031	Saint Priest en Jarez
France	Local Institution - 0013	Suresnes
France	Local Institution - 0042	Toulon
Germany	Local Institution - 0022	Frankfurt	Hessen
Germany	Local Institution - 0005	Gauting	Bayern
Germany	Local Institution - 0017	Gera
Germany	Local Institution - 0023	Muenchen
Germany	Local Institution - 0059	Wiesbaden
Israel	Local Institution - 0064	Haifa
Israel	Local Institution - 0061	Jerusalem
Israel	Local Institution - 0078	Jerusalem
Israel	Local Institution - 0079	Jerusalem
Italy	Local Institution	Milano
Italy	Local Institution - 0039	Monza	MB
Italy	Local Institution - 0028	Naples
Italy	Local Institution - 0001	Padova
Italy	Local Institution - 0020	Rozzano	MI
Poland	Local Institution - 0024	Bydgoszcz
Poland	Local Institution - 0003	Lodz
Poland	Local Institution - 0038	Otwock
Poland	Local Institution - 0058	Szczecin
Spain	Local Institution - 0041	Alicante
Spain	Local Institution - 0006	Barcelona
Spain	Local Institution - 0026	Barcelona
Spain	Local Institution - 0075	Barcelona
Spain	Local Institution - 0046	Jaen
Spain	Local Institution - 0032	Madrid
Spain	Local Institution - 0033	Majadahonda	Madrid
Turkey	Local Institution - 0066	Istanbul
Turkey	Local Institution - 0076	Istanbul
Turkey	Local Institution - 0065	Izmir
Turkey	Local Institution - 0067	Samsun
Turkey	Local Institution - 0072	Yuregir
United States	Local Institution - 0002	Ann Arbor	Michigan
United States	Local Institution - 0081	Boise	Idaho
United States	Local Institution - 0049	Brooklyn	New York
United States	Local Institution - 0012	Charleston	South Carolina
United States	Local Institution - 0077	Coeur d'Alene	Idaho
United States	Local Institution - 0074	Edgewood	Kentucky
United States	Local Institution - 0070	Fort Myers	Florida
United States	Local Institution - 0051	Fountain Valley	California
United States	Local Institution - 0073	Gainesville	Florida
United States	Local Institution - 0053	Milwaukee	Wisconsin
United States	Local Institution - 0036	Orange City	Florida
United States	Local Institution - 0045	Pensacola	Florida
United States	Local Institution	Port Saint Lucie	Florida
United States	Local Institution - 0068	Saint Petersburg	Florida
United States	Local Institution	Tallahassee	Florida
United States	Local Institution - 0080	Tucson	Arizona
United States	Local Institution	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Chile,  France,  Germany,  Israel,  Italy,  Poland,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression Free Survival by Investigator	PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression 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	Overall Response Rate (ORR) by BICR	ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From first dose to progression or death, 2.3 months
Secondary	Overall Response Rate (ORR) by Investigator	ORR is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1.; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From first dose to progression or death, 2.3 months
Secondary	Duration of Response (DOR) by Investigator	DOR is defined for participants who have a confirmed CR or PR as the date from first documented CR or PR per RECIST v1.1 to the date of the documentation of disease progression or death due to any cause, whichever is earlier.; Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.	From first dose to progression or death, 2.3 months
Secondary	Overall Survival (OS)	OS is defined as the time from randomization to the time of death due to any cause.	From randomization to time of death, 2.3 months
Secondary	Number of Participants Who Had AEs, SAEs, AEs Leading to Discontinuation and Deaths.		From first dose to progression or death, 2.3 months

External Links

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