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
Phase 1
- Conditions
- Metastatic MelanomaMedDRA version: 21.1Level: PTClassification code: 10027480Term: Metastatic malignant melanoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-504191-26-00
- Lead Sponsor
- niversitaetsklinikum Regensburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
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 Criteria
Active (symptomatic) brain metastases or leptomeningeal metastases, Uveal melanoma. Patients with conjunctival melanoma can be enrolled, Mucosal melanoma, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method