Taking people in GermanyPhase 2/3
Tests diclofenac added to a PD-1 inhibitor in metastatic melanoma
Tests adding diclofenac to ongoing PD-1 inhibitor treatment in adults with metastatic melanoma.
Key facts
- Who runs it
- Universitaetsklinikum Regensburg
- Where
- Essen, Halle (Saale), Mainz, and Regensburg, GermanySee the 4 sites
- Trial code
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 48 people, planned
- Started
- 23 Aug 2024
- Expected to end
- 31 Dec 2029
- Type of study
- Interventional
- Record updated
- 16 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with melanoma that has spread and cannot be removed by surgery. They must already be on a PD-1 inhibitor with stable disease as the best response.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Melanoma that has spread and cannot be removed by surgery, confirmed by tissue examination. Best response to the current PD-1 therapy is stable disease (SD) by RECIST 1.1.
- Earlier treatment
- Must be on an approved anti-PD-1 therapy now. People with a BRAF-V600 mutation must have had targeted therapy.
- Biomarker or test result
- BRAF-V600 mutation is not required, but people who have it must have had targeted therapy.
Main reasons for not taking part
- Brain metastases with symptoms, or metastases in the membranes around the brain
- Uveal or mucosal melanoma
- History of heart failure (NYHA III-IV), heart attack or stroke
- History of stomach ulcer or bleeding in the digestive tract
- Known allergy to diclofenac
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Germany
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), GermanyTaking people
- Universitaetsmedizin der Johannes Gutenberg - Universitaet MainzMainz, GermanyTaking people
- Universitaetsklinikum RegensburgRegensburg, GermanyTaking people
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests diclofenac added to a PD-1 inhibitor in metastatic melanomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 11 November 2026.
- Record updated
- 16 April 2026