Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04074096
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2019-08-26
Brief Title:
Binimetinib Encorafenib Pembrolizumab - Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Randomised Phase 2 Trial Testing the Addition of Upfront Stereotactic Radiosurgery to Binimetinib Encorafenib Pembrolizumab Compared to Binimetinib Encorafenib Pembrolizumab Alone in BRAFV600 Mutation-positive Melanoma With Brain Metastasis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
BEPCOME-MB
Brief Summary:
This study evaluates the addition of stereotactic radiosurgery SRS to the combination of binimetinib encorafenib pembrolizumab in the treatment of BRAFⱽ⁶⁰⁰ mutation-positive melanoma with brain metastases MBM
Detailed Description:
This is a Phase 2 randomised controlled open-label multicentric parallel trial with a safety lead-in phase to assess the efficacy and safety of adding upfront SRS to binimetinib-encorafenib-pembrolizumab combination therapy in the treatment of BRAFⱽ⁶⁰⁰ mutation-positive MBM
The study will incorporate a safety lead-in SLI phase to assess the tolerability of binimetinib-encorafenib-pembrolizumab combination therapy - SRS in the first six patients enrolled Safety will be assessed by the occurrence of predefined dose limiting toxicity DLT events The safety data will be reviewed by an independent data monitoring committee IDMC
The trial plans to enrol 150 patients who will be randomly assigned 11 to receive treatment with either
Arm A Encorafenib binimetinib pembrolizumab
Arm B Upfront stereotactic radiosurgery of all lesions 5 mm in diameter or 3 mm if other cerebral metastases 5 mm followed by encorafenib binimetinib pembrolizumab The treatment should be started more than 24 hours and less than 8 days excluded after the SRS
Patients will be treated until disease progression Pembrolizumab will be discontinued after a maximum of 35 administrations Treatment may also be terminated early at the initiative of either the patient or the investigator for any reason that would be beneficial to the patient
All patients will be followed for a total of 5 years post-randomisation
The study will incorporate a safety lead-in SLI phase to assess the tolerability of binimetinib-encorafenib-pembrolizumab combination therapy - SRS in the first six patients enrolled Safety will be assessed by the occurrence of predefined dose limiting toxicity DLT events The safety data will be reviewed by an independent data monitoring committee IDMC
The trial plans to enrol 150 patients who will be randomly assigned 11 to receive treatment with either
Arm A Encorafenib binimetinib pembrolizumab
Arm B Upfront stereotactic radiosurgery of all lesions 5 mm in diameter or 3 mm if other cerebral metastases 5 mm followed by encorafenib binimetinib pembrolizumab The treatment should be started more than 24 hours and less than 8 days excluded after the SRS
Patients will be treated until disease progression Pembrolizumab will be discontinued after a maximum of 35 administrations Treatment may also be terminated early at the initiative of either the patient or the investigator for any reason that would be beneficial to the patient
All patients will be followed for a total of 5 years post-randomisation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2021-006331-26 | EUDRACT_NUMBER | None | None |