Phase 4
Completed N=1,041
An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
Source: ClinicalTrials.gov NCT02869789 ↗Enrolled (actual)
1,041
Serious AEs
70.8%
Results posted
Jun 2023
Primary outcomePrimary: Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) — 19; 15; 4; 0 Participants
◆ Published Evidence
Established
73citations · ~24 / year
First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817.
Summary
A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.
Linked Publications
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First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs) |
19; 15; 4; 0; 0; 0 | — |
| PRIMARY Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs) |
20; 14; 3; 19; 15; 3 | — |
| SECONDARY Progression Free Survival (PFS) |
5.75; 3.91; 11.10 | — |
| SECONDARY Overall Survival (OS) |
16.76; 10.45; 26.09 | — |
| SECONDARY Objective Response Rate (ORR) |
37.3; 22.8; 45.6 | — |
| SECONDARY Duration of Response (DoR) |
27.56; 13.01; 26.05 | — |
| SECONDARY Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L) |
94.89; 91.20; 93.96; -0.84; -0.30; 2.72 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
- Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
- No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
- Tissue or Programmed death-ligand 1 (PD-L1) results available
Cohort 1A Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) score 2 or
- Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
Cohort C Inclusion Criteria:
- High Tumor Mutation Burden
Exclusion Criteria
- Untreated brain metastases
- An active malignancy that requires concurrent intervention
- Active, known or suspected autoimmune disease
- Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02869789) and the linked publication. 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. Informational only — not medical advice.