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)
Part of paid clinical trials in Anchorage, Alaska.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT06946797
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGSpecified dose on specified days
- Ipilimumab — DRUGSpecified dose on specified days
- Carboplatin — DRUGSpecified dose on specified days
- Paclitaxel — DRUGSpecified dose on specified days
- Pemetrexed — DRUGSpecified dose on specified days
- Cisplatin — DRUGSpecified dose on specified days
Study Details
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)
Key Dates
- Start date
- Sep 19, 2025
- Status verified
- May 2026
- Primary completion
- Feb 5, 2027
- Completion
- Oct 25, 2028
Study Design
- Enrollment
- 76 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A
- Experimental: Arm B
Primary Outcome Measure
Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum [ Time Frame: Up to 3 weeks ]
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0032 | Anchorage | Alaska | 99508 | - |
| Local Institution - 0062 | Los Angeles | California | 90033 | - |
| Local Institution - 0052 | Boise | Idaho | 83706 | - |
| Local Institution - 0063 | Boise | Idaho | 83702 | - |
| Local Institution - 0064 | Post Falls | Idaho | 83854 | - |
| Local Institution - 0033 | Cleveland | Ohio | 44109 | - |
| Local Institution - 0047 | Cleveland | Ohio | 44106 | - |
| Local Institution - 0051 | Allentown | Pennsylvania | 18103 | - |
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