NCT03108209

Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment

Evaluation of the Interest and Tolerance of a Photoprotection Strategy in Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment Associated or Not With Cobimetinib

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Michele Sayag · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Vemurafenib is an anti-cancer treatment indicated as monotherapy in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation. Cobimetinib is indicated in combination with Vemurafenib in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation. These treatments are associated with a lot of adverse reactions, which may lead to dose reduction, temporary interruption or discontinuation of treatment, which often leads to treatment failure or a decrease in treatment compliance. The most commonly reported adverse reactions (\> 30%) with Vemurafenib are arthralgia, rash, photosensitivity reaction, nausea, alopecia and pruritus. The most commonly reported adverse events (\> 20%) associated with Cobimetinib / Vemurafenib are diarrhea, rash, nausea, pyrexia, photosensitivity reaction, increase of alanine aminotransferase, elevation of aspartate aminotransferase, blood creatine phosphokinase elevation and vomiting. The risk of presenting a phototoxicity adverse event with Vemurafenib in monotherapy or in combination with Cobimetinib is very common (≥ 1/10) according to MedDRA. The use of optimal photoprotection including the repeated daily use of external photoprotection products is currently recommended for all patients receiving treatment with vemurafenib or with the combination of vemurafenib and cobimetinib.

Detailed description

Vemurafenib is an anti-cancer treatment indicated as monotherapy in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation. Cobimetinib is indicated in combination with Vemurafenib in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation. These treatments are associated with a lot of adverse reactions, which may lead to dose reduction, temporary interruption or discontinuation of treatment, which often leads to treatment failure or a decrease in treatment compliance. The most commonly reported adverse reactions (\> 30%) with Vemurafenib are arthralgia, rash, photosensitivity reaction, nausea, alopecia and pruritus. The most commonly reported adverse events (\> 20%) associated with Cobimetinib / Vemurafenib are diarrhea, rash, nausea, pyrexia, photosensitivity reaction, increase of alanine aminotransferase, elevation of aspartate aminotransferase, blood creatine phosphokinase elevation and vomiting. The risk of presenting a phototoxicity adverse event with Vemurafenib in monotherapy or in combination with Cobimetinib is very common (≥ 1/10) according to MedDRA. Two studies on Vemurafenib as monotherapy have demonstrated these results. One study concerns 468 patients from a randomized, open-label Phase III study in adult patients with non-resectable melanoma or stage IV with a BRAF V600 mutation, the other is a study Phase II study in a single group of patients with stage IV melanoma carrying a BRAF V600 mutation after failure of at least one prior systemic treatment. The study on the combination of Vemurafenib and Cobimetinib is a randomized, double-blind, placebo-controlled phase III study (GO28141), which evaluated Cobimetinib in combination with vemurafenib compared to vemurafenib alone Of patients with non-resectable (stage III) or metastatic (stage IV) melanoma carrying a BRAF V600 mutation naive from any treatment. The use of optimal photoprotection including the repeated daily use of external photoprotection products is currently recommended for all patients receiving treatment with vemurafenib or with the combination of vemurafenib and cobimetinib. The objective of the study is to demonstrate that the application of Photoderm Max SPF50 + Milk (UVA / UVB broad spectrum sunscreen) associated with the application of the Photoderm Max SPF50 + stick (SPF ≥ 50) on the first day of treatment with Vemurafenib or its combination with cobimetinib reduces the occurrence of this adverse event from a frequency (≥ 1/10) to a frequency (≤ 1/10) with regular application to all exposed areas.

Conditions

• Phototoxicity

Interventions

Type	Name	Description
OTHER	Photoderm Max lait SPF50+	Subjects apply Photoderm Max lait SPF50+ at the beginning of their treatment by Vemurafenib/Cobimetinib in prevention of phototoxicities
OTHER	Photoderm Max Stick SPF50+	Subjects apply Photoderm Max Stick SPF50+ at the beginning of their treatment by Vemurafenib/Cobimetinib in prevention of phototoxicities

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2017-04-11
• Last updated: 2019-08-22

Locations

1 site across 1 country: France