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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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)
Eligibility
Primary outcome measure(s)
- 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)
Trial sites (38)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0032 | Anchorage | Alaska | |
| Local Institution - 0062 | Los Angeles | California | |
| Local Institution - 0063 | Boise | Idaho | |
| Local Institution - 0052 | Boise | Idaho | |
| Local Institution - 0064 | Post Falls | Idaho | |
| Local Institution - 0047 | Cleveland | Ohio | |
| Local Institution - 0033 | Cleveland | Ohio | |
| Local Institution - 0051 | Allentown | Pennsylvania | |
| Local Institution - 0041 | Brasília | Federal District | |
| Local Institution - 0043 | Belo Horizonte | Minas Gerais | |
| Local Institution - 0038 | Porto Alegre | Rio Grande do Sul | |
| Local Institution - 0037 | Barretos | São Paulo | |
| Local Institution - 0034 | São Paulo | Brazil | |
| Local Institution - 0067 | Santiago | Santiago Metropolitan | |
| Local Institution - 0065 | Dijon | Côte-d'Or | |
| Local Institution - 0003 | Suresnes | Hauts-de-Seine | |
| Local Institution - 0010 | Paris | Île-de-France Region | |
| Local Institution - 0012 | Athens | Attikí | |
| Local Institution - 0013 | Chaïdári | Attikí | |
| Local Institution - 0011 | Thessaloniki | Kentrikí Makedonía | |
| Local Institution - 0014 | Larissa | Thessalía | |
| Local Institution - 0015 | Meldola | Emilia-Romagna | |
| Local Institution - 0057 | Udine | Friuli Venezia Giulia | |
| Local Institution - 0020 | Bergamo | Lombardy | |
| Local Institution - 0019 | Florence | Tuscany | |
| Local Institution - 0017 | Novara | Italy | |
| Local Institution - 0081 | Warsaw | Masovian Voivodeship | |
| Local Institution - 0080 | Prabuty | Pomeranian Voivodeship | |
| Local Institution - 0079 | Lodz | Łódź Voivodeship | |
| Local Institution - 0073 | Bucharest | Bucharest | |
| Local Institution - 0076 | Florești | Cluj | |
| Local Institution - 0077 | Craiova | Dolj | |
| Local Institution - 0075 | Bucharest | Romania | |
| Local Institution - 0074 | Cluj-Napoca | Romania | |
| Local Institution - 0078 | Iași | Romania | |
| Local Institution - 0031 | Soweto | Gauteng | |
| Local Institution - 0009 | Sandton | GP | |
| Local Institution - 0084 | Rondebosch | Western Cape |
On this site
📄 Opdivo (nivolumab) drug profile →More Bristol-Myers Squibb trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06946797 on ClinicalTrials.gov ↗ ← All trials in Italy