Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440850
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-19
Brief Title:
Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Pilot Clinical Trial of Vemurafenib and Cobimetinib as a Redifferentiation Strategy in High-Risk Radioactive Iodine RAI Naïve BRAFV600E Mutated Differentiated Thyroid Carcinoma Patients Undergoing Initial RAI Therapy
Status:
RECRUITING
Status Verified Date:
2024-06
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 tests how well vemurafenib and cobimetinib work in treating patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation in preparation for radioactive iodine therapy Vemurafenib and cobimetinib are used in patients whose cancer has a mutated changed form of a gene called BRAF They are in a class of medications called kinase inhibitors They work by blocking the action of an abnormal protein that signals cancer cells to multiply This helps slow or stop the spread of cancer cells Giving vemurafenib and cobimetinib may work better to treat patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation in preparation for radioactive iodine therapy
Detailed Description:
PRIMARY OBJECTIVE
I The proportion of BRAF mutated high-risk differentiated thyroid carcinoma patients who achieve excellent or indeterminate response with vemurafenib and cobimetinib treatment prior to initial radioactive iodine RAI therapy as defined by American Thyroid Association guideline
SECONDARY OBJECTIVES
I The proportion of patients who had significant change on their I-123 scan before and after the targeted therapy
II To evaluate the safety and tolerability as determined by adverse events related to vemurafenib and cobimetinib combination therapy
III To evaluate the efficacy of vemurafenib and cobimetinib in enhancing RAI avidity by assessing the progression-free survival
IV To evaluate the diagnostic and prognostic value of thyroglobulin level as determined by thyroglobulin changes associated with treatment response
V To evaluate the tumor molecular characteristics in treatment responders as compared to non-responders
OUTLINE
Patients receive vemurafenib orally PO twice per day BID for 6 weeks and cobimetinib PO once per day QD for 3 weeks followed by 1 week off and then continuing for 2 weeks Patients then receive iodine 131 PO followed by 3 additional days of vemurafenib PO BID and cobimetinib PO QD Patients receive thyrogen intramuscularly IM daily for 2 days followed by I-123 diagnostic scan during screening and on study Patients also undergo magnetic resonance imaging MRI during screening positron emission tomography PET scan or computed tomography CT scan and blood sample collection throughout the study and ultrasound imaging and I-131 whole body scan during follow up
After completion of study treatment patients are followed up every 3 months for up to 12 months
I The proportion of BRAF mutated high-risk differentiated thyroid carcinoma patients who achieve excellent or indeterminate response with vemurafenib and cobimetinib treatment prior to initial radioactive iodine RAI therapy as defined by American Thyroid Association guideline
SECONDARY OBJECTIVES
I The proportion of patients who had significant change on their I-123 scan before and after the targeted therapy
II To evaluate the safety and tolerability as determined by adverse events related to vemurafenib and cobimetinib combination therapy
III To evaluate the efficacy of vemurafenib and cobimetinib in enhancing RAI avidity by assessing the progression-free survival
IV To evaluate the diagnostic and prognostic value of thyroglobulin level as determined by thyroglobulin changes associated with treatment response
V To evaluate the tumor molecular characteristics in treatment responders as compared to non-responders
OUTLINE
Patients receive vemurafenib orally PO twice per day BID for 6 weeks and cobimetinib PO once per day QD for 3 weeks followed by 1 week off and then continuing for 2 weeks Patients then receive iodine 131 PO followed by 3 additional days of vemurafenib PO BID and cobimetinib PO QD Patients receive thyrogen intramuscularly IM daily for 2 days followed by I-123 diagnostic scan during screening and on study Patients also undergo magnetic resonance imaging MRI during screening positron emission tomography PET scan or computed tomography CT scan and blood sample collection throughout the study and ultrasound imaging and I-131 whole body scan during follow up
After completion of study treatment patients are followed up every 3 months for up to 12 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-02359 | REGISTRY | None | None |
| 21522 | OTHER | None | None |
| P30CA033572 | NIH | City of Hope Medical Center | httpsreporternihgovquickSearchP30CA033572 |