Ignite Creation Date:
2024-05-06 @ 2:49 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04439292
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-06-18
Brief Title:
Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes MATCH-Subprotocol H
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
MATCH Treatment Subprotocol H Phase II Study of Dabrafenib and Trametinib in Patients With Tumors With BRAF V600E or V600K Mutations Excluding Melanoma Thyroid Cancer Colorectal Adenocarcinoma and Non-Small Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II MATCH treatment trial identifies the effects of trametinib and dabrafenib in patients whose cancer has genetic changes called BRAF V600 mutations Dabrafenib may stop the growth of cancer by blocking BRAF proteins which may be needed for cell growth Trametinib may stop the growth of cancer cells by blocking MEK proteins which in addition to BRAF proteins may also be needed for cell growth Researchers hope to learn if giving trametinib with dabrafenib will shrink this type of cancer or stop its growth
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the proportion of patients with objective response OR to targeted study agents in patients with advanced refractory cancerslymphomasmultiple myeloma
SECONDARY OBJECTIVES
I To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancerslymphomasmultiple myeloma
II To evaluate time until death or disease progression III To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic ribonucleic acid RNA protein and imaging-based assessment platforms
IV To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens
OUTLINE
Patients receive dabrafenib mesylate orally PO twice daily BID and trametinib dimethyl sulfoxide PO once daily QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months if less than 2 years from study entry and then every 6 months for year 3 from study entry
I To evaluate the proportion of patients with objective response OR to targeted study agents in patients with advanced refractory cancerslymphomasmultiple myeloma
SECONDARY OBJECTIVES
I To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancerslymphomasmultiple myeloma
II To evaluate time until death or disease progression III To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic ribonucleic acid RNA protein and imaging-based assessment platforms
IV To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens
OUTLINE
Patients receive dabrafenib mesylate orally PO twice daily BID and trametinib dimethyl sulfoxide PO once daily QD on days 1-28 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months if less than 2 years from study entry and then every 6 months for year 3 from study entry
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 |
|---|---|---|---|
| NCI-2020-03273 | REGISTRY | None | None |
| EAY131-H | OTHER | None | None |
| EAY131-H | OTHER | None | None |
| U10CA180820 | NIH | None | None |
| U24CA196172 | NIH | CTEP | httpsreporternihgovquickSearchU24CA196172 |