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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Clinical
Trials
+41 616878333
global.trial_information@roche.com
More information about this study, what is involved and how to take part can be found on the study website.
Brain metastases, Braf-V600 mutation-positive advanced solid tumor, Braf-V600 mutation-positive melanoma with central nervous system metastases
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The purpose of the study is to test an experimental drug called RO7276389 when given by itself or in combination with another drug called cobimetinib in participants with solid tumours. Some solid tumours will have a change in a gene which in turn causes an abnormal change (mutation) in a protein called the BRAF protein. This changed BRAF protein will change the communication within the cells and hence can cause cancer. The existing cancer medicines that block the changed BRAF protein are less effective in cancers that spread to the brain. RO7276389 is an experimental drug that by itself, or in combination with cobimetinib, has been approved by health authorities for the treatment of BRAF-mutant advanced cancer in participants in a clinical study. Cobimetinib is an anticancer medicine that blocks a protein called MEK which helps cancer cells to grow.
The aims of the study are:
1. To find out the highest dose that a participant can tolerate and/or the recommended dose of RO7276389 by itself or in combination with cobimetinib.
2. To find out how safe RO7276389 by itself or in combination with cobimetinib at different doses will be and to find out what side-effects this treatment may cause
3. To find out if RO7276389 by itself or in combination with cobimetinib is effective against BRAF-mutated solid tumours or melanoma (a type of skin cancer).
4. To find out how RO7276389 by itself or in combination with cobimetinib will be distributed and eliminated from the body.
5. To find out the effect of food on the distribution and elimination of RO7276389 alone or in combination with cobimetinib from the body.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Current exclusion criteria as of 01/08/2022:1. For Part 2 only: History of or current leptomeningeal metastases2. Any metastasis requiring immediate local intervention3. Uncontrolled tumour-related pain4. Participants requiring narcotic pain medication must be on a stable regimen at the start of study treatment5. Ascites, pleural effusion, or pericardial effusion requiring medical intervention (including use of diuretics) within 6 months prior to study entry6. Active malignancy (other than the one under investigation) or a prior malignancy within the past two years prior to enrolment with some exceptions7. Active uveitis, or any history of serous retinopathy or retinal vein occlusion8. Current or history of Central Nervous System (CNS) disease unrelated to the malignancy under investigation, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease9. Active autoimmune disease, or quiescent autoimmune disease with exacerbations/flares within 1 year prior to enrolment10. Systemic anti-cancer therapy or small-molecular therapeutic(s), including but not limited to chemotherapy, investigational drugs, hormonal therapy and radiotherapy, and antibody-based agents all within 2 weeks or at least 5 half-lives, whichever is shorter, prior to start of study treatment11. Treatment with stereotactic radiosurgery or craniotomy within 1 week prior to study treatment or treatment with whole brain radiotherapy within 3 months prior study treatment. Participants with local therapy should have a complete recovery with no neurological sequelae.12. Radiation therapy to visceral metastases within 1 week prior to study treatment. Palliativeradiotherapy is allowed.13. Major surgical procedure other than for diagnosis within 2 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study14. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥2 weeks prior to screening15. Contraindication to cobimetinib or known hypersensitivity to any formulation component of cobimetinib (if applicable)16. Participants with known hypersensitivity to BRAFi and/or MEK inhibitors (MEKi)17. Increasing corticosteroid dose during the 14 days prior to initiation of study treatment or current dexamethasone or equivalent dose of >8 mg/day18. Strong CYP3A inducers (including St. John's wort and hyperforin) are prohibited during study treatment and for 2 weeks after the last dose of cobimetinib or RO7276389 (whichever is later). 19. Concomitant treatment with anti-convulsants other than gabapentin, vigabatrin andlevetiracetam are prohibited (e.g., carbamazepine, phenytoin, and phenobarbital due to strong CYP3A induction) during study treatment and for 2 weeks after the last dose of cobimetinib or RO7276389 (whichever is later)20. For combination treatment with cobimetinib, moderate and strong CYP3A inducers and inhibitors are prohibited during study treatment and for 2 weeks after the last dose of cobimetinib or RO7276389 (whichever is later)21. Concomitant treatment with drugs known to shorten the QT interval, e.g. rufinamide22. Uncontrolled diabetes or symptomatic hyperglycemia23. Any Grade ≥3 haemorrhage or bleeding event within 28 days of study treatment initiation24. History of human immunodeficiency virus (HIV) positivity25. Hepatitis B virus (HBV) infection (chronic or acute)26. Hepatitis C virus (HCV) infection (chronic or acute)
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Previous exclusion criteria:1. History of or current leptomeningeal metastases2. Any metastasis requiring immediate local intervention 3. Uncontrolled tumour-related pain4. Participants requiring narcotic pain medication must be on a stable regimen at the start of study treatment5. Ascites, pleural effusion, or pericardial effusion requiring medical intervention (including use of diuretics) within 6 months prior to study entry6. Active malignancy (other than the one under investigation) or a prior malignancy within the past two years prior to enrolment with some exceptions7. Active uveitis, or any history of serous retinopathy or retinal vein occlusion8. Current or history of Central Nervous System (CNS) disease unrelated to the malignancy under investigation, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease 9. Active autoimmune disease, or quiescent autoimmune disease with exacerbations/flares within 1 year prior to enrolment10. Systemic anti-cancer therapy or small-molecular therapeutic(s), including but not limited to chemotherapy, investigational drugs, hormonal therapy and radiotherapy, and antibody-based agents all within 2 weeks or at least 5 half-lives, whichever is shorter, prior to start of study treatment11. Treatment with stereotactic radiosurgery or craniotomy within 1 week prior to study treatment or treatment with whole brain radiotherapy within 3 months prior study treatment. Participants with local therapy should have a complete recovery with no neurological sequelae.12. Radiation therapy to visceral metastases within 1 week prior to study treatment. Palliative radiotherapy is allowed.13. Major surgical procedure other than for diagnosis within 2 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study14. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥2 weeks prior to screening15. Contraindication to cobimetinib or known hypersensitivity to any formulation component of cobimetinib (if applicable)16. Participants with known hypersensitivity to BRAFi and/or MEK inhibitors (MEKi)17. Increasing corticosteroid dose during the 14 days prior to initiation of study treatment or current dexamethasone or equivalent dose of >8 mg/day18. Concomitant treatment with CYP3A-inducing anti-epileptic drugs (such as carbamazepine, phenytoin, and phenobarbital due to strong CYP3A induction) during study treatment and for 2 weeks after the last dose of cobimetinib or RO7276389 (whichever is later)19. St. John's wort and hyperforin being strong CYP3A inducers are prohibited during study treatment and for 2 weeks after the last dose of cobimetinib or RO7276389 (whichever is later)20. Concomitant treatment with drugs known to shorten the QT interval, e.g. rufinamide21. Uncontrolled diabetes or symptomatic hyperglycaemia22. Any Grade ≥3 haemorrhage or bleeding event within 28 days of study treatment initiation23. History of human immunodeficiency virus (HIV) positivity24. Hepatitis B virus (HBV) infection (chronic or acute)25. Hepatitis C virus (HCV) infection (chronic or acute)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Clinical
Trials
+41 616878333
global.trial_information@roche.com
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Roche (United States) and funded by F. Hoffmann-La Roche.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
