Phase 3
Completed N=106
A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma
Source: ClinicalTrials.gov NCT02905266 ↗Enrolled (actual)
106
Serious AEs
66.0%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) — 15.1; 17.0 Percent of Participants
◆ Published Evidence
Not yet cited
0citations
Administration of nivolumab plus ipilimumab: Infusion of the fixed-ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800).
Summary
This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.
Linked Publications
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Administration of nivolumab plus ipilimumab: Infusion of the fixed-ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) |
15.1; 17.0 | — |
| SECONDARY Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants Affected by Hypersensitivity/Infusion Reaction Select AEs |
7.5; 9.4 | — |
| SECONDARY Percentage of Participants Affected by All Causality Grade 3 - 5 AEs |
69.8; 56.6 | — |
| SECONDARY Percentage of Participants Affected by Drug-related Grade 3 - 5 AEs |
58.5; 47.2 | — |
| SECONDARY Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI) |
60.4; 61.5; 66.8; 72.1; 77.9; 84.6 | — |
| SECONDARY Geometric Mean Concentration of Nivolumab at End of Infusion (EOI) |
20.9; 21.8; 24.2; 22.4; 27.9; 27.4 | — |
| SECONDARY Geometric Mean Trough Concentration of Ipilimumab |
10.8; 9.94; 16.5; 13.7 | — |
| SECONDARY Geometric Mean Trough Concentration of Nivolumab |
3.94; 2.75; 6.50; 4.05 | — |
| SECONDARY Objective Response Rate (ORR) |
52.8; 60.4 | — |
| SECONDARY Progression Free Survival (PFS) |
10.25; NA | — |
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Males and Females, ages 15 years ≥ of age (Except where local regulations and/or institutional policies do not allow for subjects < 18 years of age to participate)
- Subjects must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma that is unresectable or metastatic
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Subjects have 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 (NCT02905266) 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.