Phase 3 Rare Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with a cancer that has a specific gene change called a "BRAF V600 mutation," confirmed by a type of genetic testing called next-generation sequencing.
• You are 18 years old or older.
• You are willing and able to have a small tissue sample (biopsy) taken before treatment starts, as well as blood samples during the trial (for blood cancers or certain other cancers, bone marrow or lymph node samples may be taken instead).
• Your liver, kidneys, and blood counts are working well enough, as confirmed by specific lab tests outlined in the trial.
• If you are a woman who could become pregnant, you must have a negative pregnancy test before joining and agree to use two forms of contraception (at least one non-hormonal) — or remain abstinent — from the start of treatment until six months after your last dose.
• If you are a man whose partner could become pregnant, you must agree to use a barrier method of contraception (such as a condom with spermicide) or remain abstinent from the start of treatment until six months after your last dose, and ensure your partner also uses a highly effective form of contraception.

Who may not be able to join:

• You have been diagnosed with advanced or spread melanoma (a type of skin cancer) that has the BRAF V600 mutation, as this is a separate condition already treated by other approved medicines.
• You are a woman who is pregnant, breastfeeding, or planning to become pregnant during the trial or within six months of your last dose.
• Your heart's electrical activity (measured by an ECG) shows a reading that is too long — above 450 milliseconds for men or 470 milliseconds for women — on a repeat test.
• You have a personal history of certain heart rhythm problems, including a condition called Long QT syndrome or Torsades de Pointes, or you are taking any medication known to cause these problems.
• You have had an allergic reaction to either of the trial medicines (vemurafenib or cobimetinib) or any of their ingredients.
• You are unable to swallow the trial medication tablets whole — they cannot be chewed or crushed.
• You have received a live vaccine (such as yellow fever or MMR) in the 28 days before joining, or expect to need one during treatment or within six months after your last dose.
• You have had significant heart problems in the last three months, such as uncontrolled chest pain (angina), uncontrolled irregular heartbeat, severe heart failure, a heart pumping function below 50%, or a heart attack.
• You have a history of certain serious eye conditions, such as retinal detachment, severe vision loss, or certain diseases affecting the back of the eye (confirm with trial site if you have any eye condition).
• You have a history of pancreatitis (inflammation of the pancreas).
• You have had bleeding in the brain or digestive system within the last three months.
• You have ever had a bleeding stroke.
• You have previously been treated with medicines that work in the same way as vemurafenib or cobimetinib, unless your cancer has developed a specific change that might still respond to these drugs (confirm with trial site).
• You have another serious illness or condition (or its treatment) that the trial doctor believes could make participation unsafe or interfere with how the medicines work, including problems absorbing tablets.
• You have an active serious infection (bacterial, fungal, or viral) that could affect how the trial results are measured — this includes HIV, unless your HIV is well controlled on stable treatment, your immune cell count is high enough, your virus levels are undetectable, and you have had no HIV-related serious infections in the past 12 months (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.