Phototoxicity Clinical Trial
Official title:
Evaluation of the Interest and Tolerance of a Photoprotection Strategy in Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment Associated or Not With Cobimetinib
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03892564 -
Evaluation of Potential Phototoxicity Skin Reaction After Use of MC2-01 Cream
|
Phase 1 |