Clinical trial · Observational
Multicenter Study of Safety and Efficacy of Prolgolimab in Patients With Advanced Melanoma in Routine Clinical Practice
Multicenter Non-interventional Retro- and Prospective Safety and Efficacy Study of Prolgolimab (Forteca - Anti-PD1) in Patients With Advanced Melanoma (FOrteca Real Practice Assessment)
- 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)
Describe the safety, tolerability, efficacy and approaches to prescribing prolgolimab in the standard dosing regimen of 1 mg / kg every 2 weeks in patients with advanced melanoma in routine practice. Prolgolimab (Forteca, formerly BCD 100) is an IgG1 anti-PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing 'LALA' mutation.
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 Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The incidence of adverse events during prolgolimab therapy
- timeFrame
- 2 years
- description
- The rate of all grade and grade 3-5 adverse events and the rate of discontinuation of study drug(s) due to adverse events.
- measure
- Objective response rate
- timeFrame
- 3 years
- description
- The response rate during prolgolimab therapy in patients with unresectable advanced melanoma
Secondary outcomes (2)
- measure
- Progression free survival (PFS)
- timeFrame
- 3 years
- description
- The median PFS and 24 months PFS rate of patients with advanced melanoma during prolgolimab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Histological confirmed melanoma Advanced stage (unresectable III or metastatic IV) Treated by at least one therapy line including prolgolimab in routine practice - Exclusion Criteria: \- Patient participation in any interventional clinical study.
References
Publications (0)
Data not yet available