Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment

August 21, 2019 updated by: Michele Sayag

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • CHU Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject naive of i-BRAF treatment, receiving a Vemurafenib treatment in association or not with Cobimetinib in 1st or 2nd line of treatment in non resecable metastatic melonoma with BRAF V600 mutation;
  • Subject aged 18 or older ;
  • Subject who can be follow regularly by the investigator ;
  • Informed and consent subjects who read and signed the ICF ;
  • Subject who does not participate in another study, exepted therapeutic clinical trial with Vemurafenib in association or not with Cobimetinib ;
  • Compliant subject, left to the discretion of the investigator.

Exclusion Criteria:

  • Pregnant or lactating women
  • Women of reproductive age without contraception deemed effective for at least 1 month
  • For women of reproductive age receiving Cobimetinib treatment, lack of use of two effective methods of contraception, such as a condom or other barrier method (with spermicide if available).
  • Subject having a history of allergy to an ingredient of the tested products
  • Subject with skin sensitivity to sunscreens or any of the components of the products under investigation
  • Subjects taking another photosensitising treatment (left to the discretion of the investigator)
  • Subject presenting a concomitant pathology which may interfere with the course of the study (left to the discretion of the investigator)
  • Subjects with cutaneous photosensitivity or systemic disease including: lupus, dermatomyositis, porphyria, lucite ... (non-exhaustive list left to the discretion of the investigator).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
Signle arm study. Every subjects apply Photoderm Max lait SPF50+ and Photoderm stick SPF50+
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of photosensitivity reactions as assessed by CTCAE v4.03
Time Frame: 3 months
Decrease of photosensitivity reaction frequency (in total number of reaction) compared to what is described in the Summary of Product Characteristics of Vemurafenib (photosensitivity reactions are described as very common ≥ 1/10)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michele Sayag

Investigators

  • Principal Investigator: Brigitte Dreno, MD, CHU Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

March 14, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC2015/PhMZb/Fr/TCO04915

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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