Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment (NCT03108209) | Clinical Trial Compass
CompletedNot Applicable
Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment
France30 participantsStarted 2016-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 discr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of photosensitivity reactions as assessed by CTCAE v4.03