Clinical trial · Observational
A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US
A Retrospective Observational Study Comparing Nivolumab + Ipilimumab Combination vs. Nivolumab Monotherapy as First Line Treatment of Metastatic PD-L1 Positive Melanoma in the US
NCT03732560CI-TRIAL-00062576completedClinicalTrials.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 goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for PD-L1 expression treated first line (1L) with either nivolumab and ipilimumab in combination (NIVO + IPI) or nivolumab (NIVO) monotherapy
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients undergoing treatment with nivolumab and ipilimumab
- interventionNames
- Other: Non-Interventional
- label
- Patients undergoing treatment with nivolumab
- interventionNames
- Other: Non-Interventional
Primary outcomes (1)
- measure
- Overall Survival (OS) from Advanced Diagnosis
- timeFrame
- Minimum follow up 1 year
Secondary outcomes (11)
- measure
- Progression Free Survival (PFS) from Advanced Diagnosis
- timeFrame
- Minimum follow up 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults 18 years or older * First advanced of diagnosis of metastatic/Stage IV) melanoma * Tested for PD-L1 expression with a tumor proportion score (TPS) greater than or equal to 1% (Phase 1 data collection) * Initiating a first line of therapy during the index period between October 1, 2015 through July 1, 2017 * Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period) Exclusion Criteria: * Patients enrolled in a cancer treatment-related clinical trial prior to first line therapy initiation for metastatic/Stage IV) melanoma Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.