Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543576
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
External Beam Radiation Therapy and Brachytherapy With Chemotherapy and Immunotherapy for the Treatment of Stage IVB Cervical Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Cohort Study of Integrating Radiotherapy Into Chemotherapy With Pembrolizumab and Bevacizumab in Newly Diagnosed Stage IVB Cervical Cancer
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 III trial tests the safety and effectiveness of receiving external beam radiation therapy EBRT and brachytherapy along with chemotherapy consisting of cisplatin and paclitaxel and immunotherapy consisting of bevacizumab and pembrolizumab for the treatment of patients with stage IVB cervical cancer EBRT is type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body Brachytherapy also known as internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells Cisplatin is in a class of medications known as platinum-containing compounds It works by killing stopping or slowing the growth of tumor cells Paclitaxel is in a class of medications called antimicrotubule agents It stops tumor cells from growing and dividing and may kill them Bevacizumab is in a class of medications called antiangiogenic agents It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor This may slow the growth and spread of tumor A monoclonal antibody such as pembrolizumab is a type of protein that can bind to certain targets in the body such as molecules that cause the body to make an immune response antigens Giving EBRT and brachytherapy along with chemotherapy and immunotherapy may be a safe and effective way to treat patients with stage IVB cervical cancer
Detailed Description:
PRIMARY OBJECTIVE
I To demonstrate that radiotherapy can be safely integrated into chemotherapy and pembrolizumab with bevacizumab in newly diagnosed stage IVB cervical cancer to improve outcomes
SECONDARY OBJECTIVE
I To demonstrate improvements with overall response rate overall survival OS and duration of response with the addition of radiation therapy to standard of care in stage IVB cervical cancer
EXPLORATORY OBJECTIVES
I To demonstrate improved quality of life and disease-related toxicity with the addition of radiation therapy to standard of care chemotherapy in stage IVB cervical cancer
II To explore the association of known risk factors age raceethnicity smoking status baseline quality of life combined positive score CPS score 1-10 versus 10 and performance status with the change in QOL treatment outcomes and toxicities
III To explore circulating tumor deoxyribonucleic acid ctDNA as a biomarker to monitor the response to upfront chemotherapy-immunotherapy and subsequent radiation
IV To use T cell receptor repertoire sequencing TCRseq to define T cell clones present in the tumor and to establish their concordance with peripheral blood T cell clones at baseline and in response to therapy
OUTLINE
PART 1 Patients receive cisplatin intravenously IV paclitaxel IV pembrolizumab IV over 30 minutes and bevacizumab IV on day 1 of each cycle Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity Patients receive no treatment for 3 weeks
PART 2 Patients undergo EBRT for 25 treatments delivered over 5 weeks and brachytherapy over 3-5 treatments Patients also receive pembrolizumab IV over 30 minutes and bevacizumab IV on day 1 of each cycle Cycles for immunotherapy repeat every 21 days for a total of 2 years in the absence of disease progression or unacceptable toxicity Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab second course upon experiencing disease progression
Patients undergo computed tomography CT positron emission tomography PETCT andor magnetic resonance imaging MRI throughout the study Patients also undergo blood sample collection throughout the study
After completion of study treatment patients follow up at 30 days and every 6 weeks for up to 1 year then every 9 weeks
I To demonstrate that radiotherapy can be safely integrated into chemotherapy and pembrolizumab with bevacizumab in newly diagnosed stage IVB cervical cancer to improve outcomes
SECONDARY OBJECTIVE
I To demonstrate improvements with overall response rate overall survival OS and duration of response with the addition of radiation therapy to standard of care in stage IVB cervical cancer
EXPLORATORY OBJECTIVES
I To demonstrate improved quality of life and disease-related toxicity with the addition of radiation therapy to standard of care chemotherapy in stage IVB cervical cancer
II To explore the association of known risk factors age raceethnicity smoking status baseline quality of life combined positive score CPS score 1-10 versus 10 and performance status with the change in QOL treatment outcomes and toxicities
III To explore circulating tumor deoxyribonucleic acid ctDNA as a biomarker to monitor the response to upfront chemotherapy-immunotherapy and subsequent radiation
IV To use T cell receptor repertoire sequencing TCRseq to define T cell clones present in the tumor and to establish their concordance with peripheral blood T cell clones at baseline and in response to therapy
OUTLINE
PART 1 Patients receive cisplatin intravenously IV paclitaxel IV pembrolizumab IV over 30 minutes and bevacizumab IV on day 1 of each cycle Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity Patients receive no treatment for 3 weeks
PART 2 Patients undergo EBRT for 25 treatments delivered over 5 weeks and brachytherapy over 3-5 treatments Patients also receive pembrolizumab IV over 30 minutes and bevacizumab IV on day 1 of each cycle Cycles for immunotherapy repeat every 21 days for a total of 2 years in the absence of disease progression or unacceptable toxicity Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab second course upon experiencing disease progression
Patients undergo computed tomography CT positron emission tomography PETCT andor magnetic resonance imaging MRI throughout the study Patients also undergo blood sample collection throughout the study
After completion of study treatment patients follow up at 30 days and every 6 weeks for up to 1 year then every 9 weeks
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