Clinical trial • Phase II • Oncology|Dermatology

DICLOFENAC SODIUM for Metastatic melanoma

Phase II trial of DICLOFENAC SODIUM for Metastatic melanoma. open-label. 48 participants.

Overview

Trial Therapeutic Area
Oncology|Dermatology
Trial Disease
Metastatic melanoma
Trial Stage
Phase II
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
28-11-2023
First CTIS Authorization Date
05-02-2024

Trial design

open-label Phase II trial across 4 sites in Germany.

Open Label
Yes
Target Sample Size
48
Trial Duration For Participant
69

Eligibility

Recruits 48 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is for adults; a subject information sheet and informed consent form for adults is listed ('L1_SIS and ICF adults_geschwarzt'). No assent process for minors is specified..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent is for adults; a subject information sheet and informed consent form for adults is listed ('L1_SIS and ICF adults_geschwarzt'). No assent process for minors is specified.

Inclusion criteria

  • {"criterion_text":"- Histologically confirmed, unresectable metastatic melanoma"}
  • {"criterion_text":"- Ongoing treatment with an approved anti-PD-1 therapy with a best response of SD according to (RECIST 1.1.)"}
  • {"criterion_text":"- Patients with BRAF-V600 mutations must have received targeted therapy"}
  • {"criterion_text":"- Availability of adequate tumor tissue accessible for biopsy"}
  • {"criterion_text":"- ECOG 0 or 1"}
  • {"criterion_text":"- Adequate organ function"}

Exclusion criteria

  • {"criterion_text":"- Active (symptomatic) brain metastases or leptomeningeal metastases"}
  • {"criterion_text":"- Uveal melanoma. Patients with conjunctival melanoma can be enrolled"}
  • {"criterion_text":"- Mucosal melanoma"}
  • {"criterion_text":"- History of heart failure NYHA III-IV"}
  • {"criterion_text":"- History of myocardial infarction or stroke"}
  • {"criterion_text":"- History of gastric ulcer or gastrointestinal bleeding"}
  • {"criterion_text":"- Known allergy or hypersensitivity to diclofenac"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Objective response (OR) at week 9 (visit3/day64+5days), defined as a confirmed best response of either a complete response (CR) or a partial response (PR), as determined by investigator assessment using positron emission tomography in combination with computed tomography with contrast agent (diagnostic-quality PET-CT) according to the Response Evaluation Criteria in Solid Tumor, version 1.1 (RECIST 1.1.).","definition_or_measurement_approach":"Confirmed CR or PR by investigator assessment using diagnostic-quality PET-CT combined with CT with contrast according to RECIST 1.1 at week 9 (visit3/day64+5days)."}

Secondary endpoints

  • {"endpoint_text":"- Not applicable","definition_or_measurement_approach":"Not applicable"}

Recruitment

Planned Sample Size
48
Recruitment Window Months
72
Consent Approach
Informed consent provided by adult participants. Subject information and informed consent form for adults is available (document title 'L1_SIS and ICF adults_geschwarzt'). No assent or minor-specific consent documents are indicated. Protocol synopses are available in English and German.

Geography

Total Number Of Sites
4
Total Number Of Participants
48

Germany

Earliest CTIS Part Ii Submission Date
25-01-2024
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
812
Number Of Sites
4
Number Of Participants
48

Sites

Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Universitätsklinik und Poliklinik für Dermatologie und Venerologie
Principal Investigator Name
Johannes Wohlrab
Principal Investigator Email
Johannes.wohlrab@medizin.uni-halle.de
Contact Person Name
Johannes Wohlrab
Site Name
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz
Department Name
Abteilung für Dermatologie
Principal Investigator Name
Stephan Grabbe
Principal Investigator Email
stephan.grabbe@unimedizin-mainz.de
Contact Person Name
Stephan Grabbe
Site Name
Universitaetsklinikum Regensburg
Department Name
Abteilung für Dermatologie
Principal Investigator Name
Sebastian Haferkamp
Principal Investigator Email
dicit@ukr.de
Contact Person Name
Sebastian Haferkamp
Contact Person Email
dicit@ukr.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Abteilung für Dermatologie
Principal Investigator Name
Lisa Zimmer
Principal Investigator Email
lisa.zimmer@uk-essen.de
Contact Person Name
Lisa Zimmer
Contact Person Email
lisa.zimmer@uk-essen.de

Sponsor

Primary sponsor

Full Name
Universitaetsklinikum Regensburg
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
Diclo 50 - 1 A Pharma 50 mg magensaftresistente Tabletten
Active Substance
DICLOFENAC SODIUM
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
150 mg
Investigational Product Name
Diclofenac AL 25 Diclofenac-Natrium 25 mg pro magensaftresistente Tablette
Active Substance
DICLOFENAC SODIUM
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
150 mg
Investigational Product Name
PEMBROLIZUMAB
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised
Maximum Dose
400 mg
Investigational Product Name
NIVOLUMAB
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
Authorised
Maximum Dose
480 mg
Investigational Product Name
Pantoprazol TAD® 20 mg magensaftresistente Tabletten
Active Substance
PANTOPRAZOLE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
80 mg
Combination Treatment
Yes

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