Ignite Creation Date:
2024-05-06 @ 7:27 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02537600
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2015-08-18
Brief Title:
Vemurafenib and Cobimetinib Combination in BRAF Mutated Melanoma With Brain Metastasis
Sponsor:
Center Eugene Marquis
Organization:
Center Eugene Marquis
Study Overview
Official Title:
Evaluation of Cobimetinib Vemurafenib Combination Treatment in Patients With Brain Metastasis BRAFV600 Mutated Cutaneous Melanoma
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONVERCE
Brief Summary:
The purpose of this study is to determine wether cobimetinib vemurafenib combination treatment is effective in the treatment of BRAFV600-mutated melanoma patients with brain metastasis
Detailed Description:
Patients will be enrolled into 3 cohorts
Cohort A Neurologically asymptomatic patients who have not received prior local treatment
Cohort B Neurologically asymptomatic patients who have received prior local treatment
Cohort C Neurologically symptomatic patients who have or have not received prior local treatment Every patients will be treated with Vemurafenib 960 mg PO twice daily from D1 to D28 continuously
Cobimetinib 60 mg PO once daily from D1 to D21 - 1 cycle 28 days
Treatment will be administered until progression intracranial or extracranial unacceptable toxicity withdrawal of consent death or decision of the treating investigator
Patients who develop intracranial or extracranial progression and who in the opinion of the treating investigator could benefit from continuing treatment may continue treatment with vemurafenib and cobimetinib after approval from the principal investigator
Patients who discontinue the study treatment will undergo an end-of-treatment visit 30 days after the last dose of vemurafenib andor cobimetinib
Patients who discontinue the study treatment for any reason other than progression eg toxicity must be followed up every 8 weeks unless they withdraw their consent
Cohort A Neurologically asymptomatic patients who have not received prior local treatment
Cohort B Neurologically asymptomatic patients who have received prior local treatment
Cohort C Neurologically symptomatic patients who have or have not received prior local treatment Every patients will be treated with Vemurafenib 960 mg PO twice daily from D1 to D28 continuously
Cobimetinib 60 mg PO once daily from D1 to D21 - 1 cycle 28 days
Treatment will be administered until progression intracranial or extracranial unacceptable toxicity withdrawal of consent death or decision of the treating investigator
Patients who develop intracranial or extracranial progression and who in the opinion of the treating investigator could benefit from continuing treatment may continue treatment with vemurafenib and cobimetinib after approval from the principal investigator
Patients who discontinue the study treatment will undergo an end-of-treatment visit 30 days after the last dose of vemurafenib andor cobimetinib
Patients who discontinue the study treatment for any reason other than progression eg toxicity must be followed up every 8 weeks unless they withdraw their consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-001671-30 | EUDRACT_NUMBER | None | None |