Phase 2
N=230
An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03001882 ↗Enrolled (actual)
230
Serious AEs
65.6%
Results posted
Jun 2023
Primary outcome: Primary: Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB) — 30; 50; 58.8; 30.3 Percent of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Biological); Ipilimumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB) |
30; 50; 58.8; 30.3; 33.3; 33.3 | — |
| PRIMARY Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (Blood TMB Cut-point = 21-mutations/MB) |
33.3; 66.7; 64.3; 40.9; 30.8; 30.0 | — |
| PRIMARY Objective Response Rate (ORR) Per Investigator by Tissue TMB Within PD-L1 Subgroup (Tissue TMB Cut-point = 10-mutations/MB) |
25.0; 71.4; 60.0; 46.7; 27.3; 22.2 | — |
| SECONDARY Objective Response Rate (ORR) for All Treated Participants by Investigator Per RECIST 1.1 |
29.0; 39.3; 0; 29.4 | — |
| SECONDARY Disease Control Rate (DCR) for Part 1 |
58.1; 64.3; 100.0 | — |
| SECONDARY Duration of Response (DOR) for Part 1 |
24.56; 29.57 | — |
| SECONDARY Time to Response (TTR) for Part 1 |
1.84; 5.26 | — |
| SECONDARY Progression Free Survival (PFS) |
3.71; 4.30; 3.61; 6.28 | — |
| SECONDARY Overall Survival (OS) |
9.63; 22.29; 9.23; 14.78 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) for Study Part 2 |
169 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) for Study Part 2 |
102 | — |
| SECONDARY Number of Participants With Select Adverse Events (AEs) for Study Part 2 |
68; 49; 17; 28; 73; 12 | — |
Summary
The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease
- Measurable disease by CT or MRI
- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
Exclusion Criteria
- Participants with untreated central nervous system metastases
- Participants with active, known or suspected autoimmune disease
- Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
Other protocol defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03001882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.