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A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate two dosing regimens of subcutaneous Nivolumab in combination with intravenous Ipilimumab and chemotherapy in participants with previously untreated metastatic or recurrent Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase 2, Open-label, Randomized Trial to Evaluate Two Dosing Regimens of Subcutaneous Formulation of Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent NSCLC
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2025-09-19
Completion Date
2028-10-25
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Carboplatin
Specified dose on specified days
Paclitaxel
Specified dose on specified days
Pemetrexed
Specified dose on specified days
Cisplatin
Specified dose on specified days
Locations (50)
Alaska Oncology and Hematology
Anchorage, Alaska, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Local Institution - 0088
Newport Beach, California, United States
Local Institution - 0063
Boise, Idaho, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Beacon Cancer Care
Post Falls, Idaho, United States
Local Institution - 0047
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Hospital Sirio Libanes
Brasília, Federal District, Brazil
Hospital Luxemburgo
Belo Horizonte, Minas Gerais, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, Brazil
Local Institution - 0068
Antofagasta, AN, Chile
Local Institution - 0069
Viña del Mar, Región de Valparaíso, Chile
Bradfordhill
Santiago, Santiago Metropolitan, Chile
Centre Georges François Leclerc
Dijon, Côte-d'Or, France
Hôpital Foch
Suresnes, Hauts-de-Seine, France
Groupe hospitalier Paris saint Joseph
Paris, Île-de-France Region, France
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attikí, Greece
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, Greece
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, Greece
University General Hospital of Larissa
Larissa, Thessalía, Greece
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Emilia-Romagna, Italy
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale
Udine, Friuli Venezia Giulia, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy
Local Institution - 0025
Guadalajara, Jalisco, Mexico
Local Institution - 0058
Monterrey, Nuevo León, Mexico
Local Institution - 0027
Mérida, Yucatán, Mexico
Local Institution - 0024
México, Mexico
Local Institution - 0022
Puebla City, Mexico
Mazowiecki Szpital Onkologiczny
Warsaw, Masovian Voivodeship, Poland
Szpital Specjalistyczny w Prabutach Spolka z o.o.
Prabuty, Pomeranian Voivodeship, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Łódź Voivodeship, Poland
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu"
Bucharest, București, Romania
SC Radiotherapy Center Cluj SRL
Florești, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, Romania
Centrul de Diagnostic si Tratament Provita
Bucharest, Romania
Institutul Oncologic Cluj
Cluj-Napoca, Romania
Institutul Regional de Oncologie
Iași, Romania
Local Institution - 0066
Pretoria, Gauteng, South Africa
Wits Clinical Research
Soweto, Gauteng, South Africa
Local Institution - 0009
Sandton, GP, South Africa
Cancercare Rondebosch Oncology
Rondebosch, Western Cape, South Africa
Local Institution - 0070
Adana, Turkey (Türkiye)
Local Institution - 0072
Ankara, Turkey (Türkiye)
Local Institution - 0071
Istanbul, Turkey (Türkiye)