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
Key facts
- Where
- Essen, Halle (Saale), Mainz és Regensburg, NémetországSee the 4 sites
- Phase
- 2/3. fázis
Where in Németország
- Universitaetsklinikum Essen (AoR)Essen, NémetországTaking people
- Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), NémetországTaking people
- Universitaetsmedizin der Johannes Gutenberg - Universitaet MainzMainz, NémetországTaking people
- Universitaetsklinikum RegensburgRegensburg, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaetsklinikum Regensburg
- Trial code
- EU 2023-504191-26-00
- Record updated
- 2026. április 16.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Active (symptomatic) brain metastases or leptomeningeal metastases; Uveal melanoma. Patients with conjunctival melanoma can be enrolled; Mucosal melanoma.