Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580054
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Pembrolizumab for the Treatment of Locally Advanced andor Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pembrolizumab for Orbital and Periocular Cutaneous Squamous Cell Carcinoma cSCC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 trial studies how well pembrolizumab works in treating patients with orbital eye socket andor periorbital surrounding the eye socket cutaneous squamous cell cancer cSCC that has spread to nearby tissue or lymph nodes locally advanced or has come back after a period of improvement recurrent Skin cancers that are close to the eye or on the eyelid often have more genetic heredity changes than other types of cancers This means that the deoxyribonucleic acid DNA the building blocks of the body that determine such things as the color of the hair in tumor tissue has been altered compared to normal tissue It is thought cancer cells with these DNA changes are more likely to respond to a type of drug called immunotherapy Immunotherapy with monoclonal antibodies such as pembrolizumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Pembrolizumab is approved for patients with recurrent or metastatic cSCC not amenable responsive to cure by surgery or radiation Giving pembrolizumab may work better in treating patients with locally advanced or recurrent orbital andor periorbital cSCC
Detailed Description:
PRIMARY OBJECTIVE
I To determine whether treatment of patients with locally advanced or recurrent orbital andor periocular cSCC with pembrolizumab will be associated with tumor response
SECONDARY OBJECTIVES
I To assess the globe preservation rate among patients with locally advanced or recurrent orbital andor periocular cSCC treated with pembrolizumab
II To determine whether treatment with pembrolizumab of patients with locally advanced or recurrent orbital andor periocular cSCC will prevent progression of disease
EXPLORATORY OBJECTIVES
I To evaluate next generation sequencing NGS and correlate with response to therapy for patients with available tissue
II Correlate visual function to location and size of tumor over the course of treatment
III To identify if the presence of human papillomavirus HPV in the cSCC affects the tumor response
IV To determine the duration of response DOR at 2 years
OUTLINE
Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo magnetic resonance imaging MRI or computed tomography CT and photographs of tumor throughout the study
After completion of study treatment patients are followed up at 30 days and then every 9 weeks for 52 weeks and then every 12 weeks for up to 2 years
I To determine whether treatment of patients with locally advanced or recurrent orbital andor periocular cSCC with pembrolizumab will be associated with tumor response
SECONDARY OBJECTIVES
I To assess the globe preservation rate among patients with locally advanced or recurrent orbital andor periocular cSCC treated with pembrolizumab
II To determine whether treatment with pembrolizumab of patients with locally advanced or recurrent orbital andor periocular cSCC will prevent progression of disease
EXPLORATORY OBJECTIVES
I To evaluate next generation sequencing NGS and correlate with response to therapy for patients with available tissue
II Correlate visual function to location and size of tumor over the course of treatment
III To identify if the presence of human papillomavirus HPV in the cSCC affects the tumor response
IV To determine the duration of response DOR at 2 years
OUTLINE
Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo magnetic resonance imaging MRI or computed tomography CT and photographs of tumor throughout the study
After completion of study treatment patients are followed up at 30 days and then every 9 weeks for 52 weeks and then every 12 weeks for up to 2 years
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