Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414590
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-25
Brief Title:
Neoadjuvant Tebentafusp for Uveal Melanoma
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Neoadjuvant Tebentafusp in Patients With Locally Advanced Unresectable Primary Uveal Melanoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 tebentafusp works to shrink tumors prior to primary treatment with surgery or radiation in patients with uveal eye melanoma that has spread to nearby tissue or lymph nodes locally advanced or that cannot be removed by surgery unresectable Tebentafusp is a drug that binds to melanoma tumor cells as well as immune cells called T-cells This binding causes an immune response against the melanoma cells which leads to tumor cell death Tebentafusp has been approved for the treatment of locally advanced and unresectable uveal melanoma Giving tebentafusp before primary treatment with surgery or radiation may help shrink the tumor prevent the disease from spreading or reduce the likelihood that patients will require total eye removal called enucleation
Detailed Description:
PRIMARY OBJECTIVE
I To assess the efficacy of neoadjuvant tebentafusp in patients with large surgically unresectable other than complete enucleation of eye primary uveal melanoma
SECONDARY OBJECTIVES
I To assess the local eye and systemic toxicity with tebentafusp treatment II To investigate the usefulness of circulating tumor-derived deoxyribonucleic acid DNA ctDNA as a biomarker for response
EXPLORATORY OBJECTIVES
I To assess sight preservation II To assess the change in radiation dose to the fovea
OUTLINE
Patients receive tebentafusp intravenously IV over 15-20 minutes on days 1 8 15 and 22 of each cycle Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity Within 28 days of their last dose of tebentafusp patients undergo standard of care SOC primary eye treatment plaque radiotherapy or eye enucleation as decided by their treating physician Patients also undergo echocardiography ECHO or multigated acquisition scan MUGA at screening ophthalmic ultrasound optical coherence tomography OCT wide-angle fundus imaging OCT angiography OCTA fluorescein angiography orbit magnetic resonance imaging MRI and collection of blood samples throughout the trial undergo biopsy and collection of aqueous humour samples at screening and on study and undergo abdominal MRI and chest and pelvis computed tomography CT at screening and during follow up
After completion of primary eye treatment patients are followed up at 3 months and then every 3 months for up to 5 years
I To assess the efficacy of neoadjuvant tebentafusp in patients with large surgically unresectable other than complete enucleation of eye primary uveal melanoma
SECONDARY OBJECTIVES
I To assess the local eye and systemic toxicity with tebentafusp treatment II To investigate the usefulness of circulating tumor-derived deoxyribonucleic acid DNA ctDNA as a biomarker for response
EXPLORATORY OBJECTIVES
I To assess sight preservation II To assess the change in radiation dose to the fovea
OUTLINE
Patients receive tebentafusp intravenously IV over 15-20 minutes on days 1 8 15 and 22 of each cycle Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity Within 28 days of their last dose of tebentafusp patients undergo standard of care SOC primary eye treatment plaque radiotherapy or eye enucleation as decided by their treating physician Patients also undergo echocardiography ECHO or multigated acquisition scan MUGA at screening ophthalmic ultrasound optical coherence tomography OCT wide-angle fundus imaging OCT angiography OCTA fluorescein angiography orbit magnetic resonance imaging MRI and collection of blood samples throughout the trial undergo biopsy and collection of aqueous humour samples at screening and on study and undergo abdominal MRI and chest and pelvis computed tomography CT at screening and during follow up
After completion of primary eye treatment patients are followed up at 3 months and then every 3 months for up to 5 years
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