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)

Phase 2

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Nivolumab; Drug: Ipilimumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin

• 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

Study Timeline

• Study First Submitted: 2025-04-25
• Study First Submitted QC: 2025-04-25
• Study First Posted: 2025-04-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-28
• Study Start: 2025-08-02
• Primary Completion: 2027-02-05
• Study Completion: 2028-10-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

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
Trough observed concentration (Ctrough) of subcutaneous Nivolumab	At Cycle 7 Day 1 (Week 18)
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

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 (49)

Local Institution - 0043; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Alaska Oncology and Hematology; 🇺🇸 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 - 0041; 🇧🇷 Brasilia, Distrito Federal, Brazil

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