Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04511013
Status:
RECRUITING
Last Update Posted:
2023-08-14
First Post:
2020-08-10
Brief Title:
A Study to Compare the Administration of Encorafenib Binimetinib Nivolumab Versus Ipilimumab Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Randomized Phase 2 Trial of Encorafenib Binimetinib Nivolumab vs Ipilimumab Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This phase II trial compares the effect of encorafenib binimetinib and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain brain metastases Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma
Detailed Description:
PRIMARY OBJECTIVE
I To compare progression-free survival PFS per Response Evaluation Criteria in Solid Tumors RECIST 11 between participants randomized to the triplet combination of encorafenib binimetinib nivolumab versus the doublet combination of ipilimumab nivolumab among participants with BRAF-V600 mutant melanoma that has metastasized to the brain
SECONDARY OBJECTIVES
I To estimate the overall survival OS of participants in each treatment arm II To estimate the objective response rate ORR confirmed and unconfirmed complete and partial responses per RECIST 11 in each treatment arm
III To estimate the intracranial response rate ICRR defined as confirmed and unconfirmed complete and partial response per modified RECIST for brain metastases mRECIST
IV To evaluate the duration of response per RECIST 11 and the duration of ICRR per mRECIST and per Response Assessment in Neuro-Oncology RANO-Brain Metastases BM and immunotherapy iRANO in each treatment arm
V To evaluate the toxicity profile of each treatment arm VI To evaluate current and emerging radiographic response criteria modified RECIST 11 modified RANO-BM and iRANO by a retrospective blinded independent centralized review BICR of banked images
BANKING OBJECTIVE
I To bank tumor tissue cerebral spinal fluid CSF stool and blood samples for future correlative studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive encorafenib orally PO once daily QD on days 1-28 binimetinib PO twice daily BID on days 1-28 and nivolumab intravenously IV on day 1 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM II Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4 Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for 2 years and then annually until 3 years after randomization
I To compare progression-free survival PFS per Response Evaluation Criteria in Solid Tumors RECIST 11 between participants randomized to the triplet combination of encorafenib binimetinib nivolumab versus the doublet combination of ipilimumab nivolumab among participants with BRAF-V600 mutant melanoma that has metastasized to the brain
SECONDARY OBJECTIVES
I To estimate the overall survival OS of participants in each treatment arm II To estimate the objective response rate ORR confirmed and unconfirmed complete and partial responses per RECIST 11 in each treatment arm
III To estimate the intracranial response rate ICRR defined as confirmed and unconfirmed complete and partial response per modified RECIST for brain metastases mRECIST
IV To evaluate the duration of response per RECIST 11 and the duration of ICRR per mRECIST and per Response Assessment in Neuro-Oncology RANO-Brain Metastases BM and immunotherapy iRANO in each treatment arm
V To evaluate the toxicity profile of each treatment arm VI To evaluate current and emerging radiographic response criteria modified RECIST 11 modified RANO-BM and iRANO by a retrospective blinded independent centralized review BICR of banked images
BANKING OBJECTIVE
I To bank tumor tissue cerebral spinal fluid CSF stool and blood samples for future correlative studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive encorafenib orally PO once daily QD on days 1-28 binimetinib PO twice daily BID on days 1-28 and nivolumab intravenously IV on day 1 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM II Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4 Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 6 months for 2 years and then annually until 3 years after randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| NCI-2020-05496 | REGISTRY | None | None |
| S2000 | OTHER | None | None |
| S2000 | OTHER | None | None |
| U10CA180888 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180888 |