Phase 3
Completed N=387
A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Source: ClinicalTrials.gov NCT02714218 ↗Enrolled (actual)
387
Serious AEs
64.9%
Results posted
Apr 2019
Primary outcomePrimary: The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs) — 32.8; 45.5 Percentage of participants — p=0.0144
◆ Published Evidence
Highly cited
394citations · ~56 / year
Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial.
Summary
The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.
Linked Publications (2)
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Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial.
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Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs) |
32.8; 45.5 | 0.0144 sig |
| SECONDARY Objective Response Rate (ORR) |
47.8; 53.4 | 0.2923 |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Progression Free Survival (PFS) |
10.18; 9.99 | 0.4512 |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale |
-2.1; -4.9; -1.9; -2.7; -1.4; -2.7 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale |
-2.5; -8.8; -6.6; 2.1; -1.8; -5.2 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale |
4.5; 4.4; 0.0; 6.6; 3.9; 4.5 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale |
-3.4; -1.9; -2.6; -5.9; -1.9; -6.0 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale |
-3.1; -6.1; -6.3; -2.8; -4.6; -3.2 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status |
0.5; -0.5; 0.0; 5.0; -1.5; 0.0 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea |
4.4; 6.3; 5.8; 2.1; 2.7; 2.3 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia |
0.6; -1.5; -0.5; -2.8; -0.9; -6.3 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss |
3.0; 4.8; 2.1; -1.4; 1.4; -3.5 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation |
0.3; 2.4; 5.3; -2.8; 3.7; 1.1 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea |
1.4; 1.2; 8.5; 2.8; 2.3; -1.7 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties |
2.0; 2.4; 1.1; 4.9; 2.8; 5.3 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue |
5.1; 11.5; 9.2; 5.1; 4.4; 7.9 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting |
1.5; 4.9; -0.3; 3.1; -2.3; 1.1 | — |
| SECONDARY Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain |
-1.7; 1.5; -2.9; -2.8; -5.7; 1.7 | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that is unresectable or metastatic
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
Exclusion Criteria
- Subjects with active brain metastases or leptomeningeal metastases
- Subjects with ocular melanoma
- Subjects with active, known or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02714218) 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.