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)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06946797
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Cisplatin - Arm B Ipilimumab - Arm B Carboplatin - Arm B Paclitaxel - Arm B Pemetrexed - Arm A Nivolumab - Arm A Ipilimumab - Arm A Carboplatin - Arm A Paclitaxel - Arm A Pemetrexed - Arm A Cisplatin - Arm B Nivolumab -
- Primary Outcome Measures
Name Time Method Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum Up to 3 weeks Time to peak concentration (Tmax) of subcutaneous Nivolumab in serum Up to 3 weeks Area under the concentration-time curve within a dosing interval (AUC(TAU)) of subcutaneous Nivolumab in serum Up to 3 weeks Concentration at the end of a dosing interval (Ctau) of subcutaneous Nivolumab in serum Up to 3 weeks Trough observed concentration (Ctrough) of subcutaneous Nivolumab At Cycle 7 Day 1 (Week 18)
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to approximately 2.5 years Number of participants with serious adverse events (SAEs) Up to approximately 2.5 years Number of participants with drug related AEs Up to approximately 2.5 years Number of participants with Immune Mediated Adverse Events (IMAEs) Up to approximately 2.5 years Number of participants with AEs leading to discontinuation Up to approximately 2.5 years Number of deaths Up to approximately 2.5 years Number of participants with anti-nivolumab antibodies Up to approximately 2.5 years Number of participants with anti-ipilimumab antibodies Up to approximately 2.5 years Number of participants with neutralizing antibodies Up to approximately 2.5 years Cmax of intravenous Ipilimumab in serum Up to 6 weeks Tmax of intravenous Ipilimumab in serum Up to 6 weeks AUC(TAU) of intravenous Ipilimumab in serum Up to 6 weeks Ctau of intravenous Ipilimumab in serum Up to 6 weeks
Trial Locations
- Locations (48)
Local Institution - 0079
🇵🇱Łódź, Łódzkie, Poland
Local Institution - 0041
🇧🇷Brasilia, Distrito Federal, Brazil
Local Institution - 0032
🇺🇸Anchorage, Alaska, United States
Local Institution - 0062
🇺🇸Los Angeles, California, United States
Local Institution - 0063
🇺🇸Boise, Idaho, United States
Local Institution - 0052
🇺🇸Boise, Idaho, United States
Local Institution - 0064
🇺🇸Post Falls, Idaho, United States
Local Institution - 0047
🇺🇸Cleveland, Ohio, United States
Local Institution - 0033
🇺🇸Cleveland, Ohio, United States
Local Institution - 0051
🇺🇸Allentown, Pennsylvania, United States
Local Institution - 0038
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution - 0037
🇧🇷Barretos, São Paulo, Brazil
Local Institution - 0034
🇧🇷São Paulo, Brazil
Local Institution - 0068
🇨🇱Antofagasta, AN, Chile
Local Institution - 0067
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Local Institution - 0069
🇨🇱Viña del Mar, Valparaíso, Chile
Local Institution - 0065
🇫🇷Dijon, Côte-d'Or, France
Local Institution - 0003
🇫🇷Suresnes, Hauts-de-Seine, France
Local Institution - 0010
🇫🇷Paris, Île-de-France, France
Local Institution - 0012
🇬🇷Athens, Attikí, Greece
Local Institution - 0013
🇬🇷Chaidari, Attikí, Greece
Local Institution - 0011
🇬🇷Thessaloniki, Kentrikí Makedonía, Greece
Local Institution - 0014
🇬🇷Larissa, Thessalía, Greece
Local Institution - 0015
🇮🇹Meldola, Emilia-Romagna, Italy
Local Institution - 0057
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Local Institution - 0020
🇮🇹Bergamo, Lombardia, Italy
Local Institution - 0019
🇮🇹Firenze, Toscana, Italy
Local Institution - 0017
🇮🇹Novara, Italy
Local Institution - 0025
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0058
🇲🇽Monterrey, Nuevo León, Mexico
Local Institution - 0027
🇲🇽Merida, Yucatán, Mexico
Local Institution - 0024
🇲🇽Mexico, Mexico
Local Institution - 0022
🇲🇽Puebla, Mexico
Local Institution - 0081
🇵🇱Warszawa, Mazowieckie, Poland
Local Institution - 0080
🇵🇱Prabuty, Pomorskie, Poland
Local Institution - 0075
🇷🇴Bucharest, București, Romania
Local Institution - 0073
🇷🇴Bucharest, București, Romania
Local Institution - 0076
🇷🇴Florești, Cluj, Romania
Local Institution - 0077
🇷🇴Craiova, Dolj, Romania
Local Institution - 0074
🇷🇴Cluj, Romania
Local Institution - 0078
🇷🇴Iași, Romania
Local Institution - 0066
🇿🇦Pretoria, Gauteng, South Africa
Local Institution - 0031
🇿🇦Soweto, Gauteng, South Africa
Local Institution - 0009
🇿🇦Sandton, GP, South Africa
Local Institution - 0084
🇿🇦Rondebosch, Western Cape, South Africa
Local Institution - 0070
🇹🇷Adana, Turkey
Local Institution - 0072
🇹🇷Ankara, Turkey
Local Institution - 0071
🇹🇷Istanbul, Turkey