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

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504191-26-00

Acronym

DICIT

Enrollment

Registered

2024-02-05

Start date

2024-08-23

Completion date

Unknown

Last updated

2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Melanoma

Brief summary

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.).

Detailed description

Not applicable

Interventions

DRUGPEMBROLIZUMAB

DRUGDiclo 50 - 1 A Pharma 50 mg magensaftresistente Tabletten

DRUGNIVOLUMAB

DRUGDiclofenac AL 25 Diclofenac-Natrium 25 mg pro magensaftresistente Tablette

DRUGPantoprazol TAD® 20 mg magensaftresistente Tabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.).	—

Measure

Time frame

—

Secondary

Measure	Time frame
Not applicable	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026