Clinical trial · Interventional
A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
NCT02714218CI-TRIAL-00059296completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab 1 mg/kg IV | Biological | Ipilimumab | ALIAS |
| Ipilimumab 3 mg/kg IV | Biological | Ipilimumab | ALIAS |
| Nivolumab 1 mg/kg IV | Biological | Nivolumab | ALIAS |
| Nivolumab 3 mg/kg IV | Biological | Nivolumab | ALIAS |
| Nivolumab 6 mg/kg IV | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg IV
- description
- Specified dose on specified days
- interventionNames
- Biological: Nivolumab 3 mg/kg IV
- Biological: Ipilimumab 1 mg/kg IV
- type
- EXPERIMENTAL
- label
- Ipilimumab 3 mg/kg IV + Nivolumab 1 mg/kg IV
- description
- Specified dose on specified days
- interventionNames
- Biological: Nivolumab 1 mg/kg IV
- Biological: Ipilimumab 3 mg/kg IV
- type
- EXPERIMENTAL
- label
- Nivolumab 6 mg/kg IV + Ipilimumab 1 mg/kg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDLong GV, Larkin J, Schadendorf D, Grob JJ, Lao CD, Marquez-Rodas I, Wagstaff J, Lebbe C, Pigozzo J, Robert C, Ascierto PA, Atkinson V, Postow MA, Atkins MB, Sznol M, Callahan MK, Topalian SL, Sosman JA, Kotapati S, Thakkar PK, Ritchings C, Pe Benito M, Re S, Soleymani S, Hodi FS. Pooled Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone in Patients With Advanced Melanoma. J Clin Oncol. 2025 Mar 10;43(8):938-948. doi: 10.1200/JCO.24.00400. Epub 2024 Nov 6. PMID 39504507
- DERIVEDLebbe C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J. 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. J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27. PMID 30811280