NCT02392871

Radiotherapy & Combi in Metastatic Melanoma

An Open-label, Single-arm, Phase I/II, Multicentre Study to Evaluate the Safety and Efficacy of the Combination of Dabrafenib, Trametinib and Palliative Radiotherapy in Patients with Unresectable (stage IIIc) and Metastatic (stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Melanoma and Skin Cancer Trials Limited · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the side effects and safety, and effectiveness of combining dabrafenib and trametinib with radiotherapy. Previous and ongoing clinical trials have demonstrated the effectiveness and safety of combining both dabrafenib and trametinib compared with dabrafenib alone. This has led to the approval for the use of both drugs in combination in people with metastatic melanoma with the BRAF mutation. Melanoma that has spread to other parts of the body may also benefit from radiotherapy to help reduce symptoms from melanoma. Previous studies have shown that melanoma may be sensitive to radiotherapy and that it can help to improve quality of life. The intention of the CombiRT study is to establish if dabrafenib, trametinib and radiotherapy combined is a safe and effective treatment for metastatic melanoma.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
RADIATION	Palliative radiotherapy
DRUG	Dabrafenib and trametinib (combination)	Patients should be taking dabrafenib and trametinib for at least 2 weeks prior to enrolment into the study.

Timeline

• Start date: 2015-05-01
• Primary completion: 2019-09-23
• Completion: 2020-04-17
• First posted: 2015-03-19
• Last updated: 2024-11-27

Locations

3 sites across 1 country: Australia