2023-504191-26-00RecruitingPhase 2/3
DICIT: Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Apr 2026
Brief summary (registry, in English)
To evaluate the efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved SD as best response in metastatic melanoma patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 28 Nov 2023
- Start date
- 23 Aug 2024
- Lead sponsor
- Universitaetsklinikum Regensburg
- Diseases
- Melanoma
- EU CT number
- 2023-504191-26-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 48
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of heart failure NYHA III-IV
- History of myocardial infarction or stroke
- History of gastric ulcer or gastrointestinal bleeding
- Known allergy or hypersensitivity to diclofenac
Other
- Active (symptomatic) brain metastases or leptomeningeal metastases
- Uveal melanoma. Patients with conjunctival melanoma can be enrolled
- Mucosal melanoma
Who the study is looking for
- Histologically confirmed, unresectable metastatic melanoma
- Ongoing treatment with an approved anti-PD-1 therapy with a best response of SD according to (RECIST 1.1.)
- Patients with BRAF-V600 mutations must have received targeted therapy
- Availability of adequate tumor tissue accessible for biopsy
- ECOG 0 or 1
- Adequate organ function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Recruiting |
| Martin-Luther-Universitaet Halle-Wittenberg | Halle (Saale) | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz | Mainz | Germany | Recruiting |
| Universitaetsklinikum Regensburg | Regensburg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.