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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
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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data 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