Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
48
Countries
1
Sites
4
Metastatic Melanoma
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.
Key facts
- Sponsor
- Universitaetsklinikum Regensburg
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 23 Aug 2024 → ongoing
- Decision date (initial)
- 2024-02-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Deutsche Krebshilfe
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
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.
Secondary objectives 1
- Not applicable
Conditions and MedDRA coding
Metastatic Melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10027480 | Metastatic malignant melanoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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 7
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.).
Secondary endpoints 1
- Not applicable
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Diclo 50 - 1 A Pharma 50 mg magensaftresistente Tabletten
PRD783773 · Product
- Active substance
- Diclofenac Sodium
- Substance synonyms
- DICLOFENACUM NATRICUM, DICLOPHENAC SODIUM, SODIUM 2-[2-[(2,6-DICHLOROPHENYL)AMINO]PHENYL]ACETATE
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 63 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AB05 — DICLOFENAC
- Marketing authorisation
- 11959.00.00
- MA holder
- 1 A PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Diclofenac AL 25 Diclofenac-Natrium 25 mg pro magensaftresistente Tablette
PRD1968919 · Product
- Active substance
- Diclofenac Sodium
- Substance synonyms
- DICLOFENACUM NATRICUM, DICLOPHENAC SODIUM, SODIUM 2-[2-[(2,6-DICHLOROPHENYL)AMINO]PHENYL]ACETATE
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 63 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AB05 — DICLOFENAC
- Marketing authorisation
- 23078.00.00
- MA holder
- ALIUD PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
SCP6094344 · ATC
- Active substance
- Pembrolizumab
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — PEMBROLIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP8265340 · ATC
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 8640 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF01 — NIVOLUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pantoprazol TAD® 20 mg magensaftresistente Tabletten
PRD454068 · Product
- Active substance
- Pantoprazole
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 63 Day(s)
- Authorisation status
- Authorised
- ATC code
- A02BC02 — PANTOPRAZOLE
- Marketing authorisation
- 67016.00.00
- MA holder
- TAD PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Regensburg
- Sponsor organisation
- Universitaetsklinikum Regensburg
- Address
- Franz-Josef-Strauss-Allee 11, Grass-Oberisling Grass-Oberisling
- City
- Regensburg
- Postcode
- 93053
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Regensburg
- Contact name
- Department of Dermatology
Public contact point
- Organisation
- Universitaetsklinikum Regensburg
- Contact name
- Department of Dermatology
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 48 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Essen AöR
Abteilung für Dermatologie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Regensburg
Abteilung für Dermatologie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsmedizin Der Johannes Gutenberg-Universitaet Mainz
Abteilung für Dermatologie, Langenbeckstrasse 1, Oberstadt, Mainz
Martin-Luther-Universitaet Halle-Wittenberg
Universitätsklinik und Poliklinik für Dermatologie und Venerologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2024-08-23 | 2024-09-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-504191-26-00_geschwarzt | 2 |
| Protocol (for publication) | D4_Diary_GER_2023-504191-26-00 | 1 |
| Protocol (for publication) | D4_Patientcard_GER_2023-504191-26-00 | 1 |
| Recruitment arrangements (for publication) | L2_Other subject information material | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_geschwarzt | 2.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DEU_2023-504191-26-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2023-504191-26-00 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-28 | Germany | Acceptable 2024-01-25
|
2024-02-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-16 | Germany | Acceptable 2025-12-23
|
2025-12-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-25 | Germany | Acceptable | 2026-04-16 |