Clinical trial · Observational
A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
NCT01511913CI-TRIAL-00055675IMAGEcompletedClinicalTrials.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 examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting
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 |
|---|---|---|---|
| Advanced Cutaneous Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Ipilimumab treatment cohort of 1106 prospective participants
- label
- Non-Ipilimumab treatment cohort of 305 prospective participants
- label
- Retrospective cohort of 177 participants
Primary outcomes (4)
- measure
- Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting
- timeFrame
- Every 12 months up to 5 years
- measure
- Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events
- timeFrame
- Every 12 months up to 5 years
- measure
- Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Diagnosis of unresectable or metastatic melanoma * Age of 18 years or older at time of entry into the study * Patients who have initiated treatment for unresectable or metastatic melanoma at medical practice (e.g. community-based, office-based, hospital-based, academic setting)within 21 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before informed consent for this study, and treatment must be initiated within 28 days after informed consent * Ipilimumab-treated patients must be receiving treatment for the indication(s) approved in their country of residence or where they are receiving treatment Exclusion Criteria: * Current or pending participation in a clinical trial examining therapy for the treatment of any cancer (including unresectable or metastatic melanoma) * Current use of therapy to treat a primary cancer other than melanoma
References
Publications (2)
- RESULTDalle S, Mortier L, Corrie P, Lotem M, Board R, Arance AM, Meiss F, Terheyden P, Gutzmer R, Buysse B, Oh K, Brokaw J, Le TK, Mathias SD, Scotto J, Lord-Bessen J, Moshyk A, Kotapati S, Middleton MR. Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study. BMC Cancer. 2021 May 29;21(1):642. doi: 10.1186/s12885-021-08032-y. PMID 34051732
- RESULTMiddleton MR, Dalle S, Claveau J, Mut P, Hallmeyer S, Plantin P, Highley M, Kotapati S, Le TK, Brokaw J, Abernethy AP. Real-world treatment practice in patients with advanced melanoma in the era before ipilimumab: results from the IMAGE study. Cancer Med. 2016 Jul;5(7):1436-43. doi: 10.1002/cam4.717. Epub 2016 Apr 26. PMID 27118102