Clinical trial · Observational
Ipilimumab-induced Lung Toxicity: Observational Study
Ipilimumab-induced Lung Toxicity: A Prospective Observational Study on Pulmonary Function Changes in Patients With Metastatic Melanoma
NCT02755233CI-TRIAL-00021950Ipi-Lu-ToxcompletedClinicalTrials.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)
Serial spirometries and measurements of CO-diffusion capacity (DLCO) in patients with MM before and during treatment with ipilimumab are performed. A reduction from baseline of forced vital capacity (FVC) of ≥10%, or ≥15% of DLCO was defined clinically meaningful, thus indicative for pulmonary toxicity.
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 |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pulmonary Function | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pulmonary function
- description
- Patients in whom treatment with ipilimumab due to metastatic melanoma is indicated
- interventionNames
- Other: Pulmonary Function
Primary outcomes (1)
- measure
- Relative reduction of DLCO of more than 15% from the baseline value during follow-up
- timeFrame
- 9 weeks
- description
- A relative reduction of ≥15% from baseline of DLCO was chosen as clinically meaningful, thus indicative of a possible interstitial lung disease as a consequence of ipilimumab induced pulmonary toxicity
Secondary outcomes (1)
- measure
- Relative reduction of FVC of more than 10% from the baseline value during
- timeFrame
- 9 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Established diagnosis of metastatic melanoma Exclusion Criteria: * Acute pulmonary infection at enrolment
References
Publications (0)
Data not yet available
No reference posted for this study.