Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870800
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-25
First Post:
2023-04-11
Brief Title:
Neoadjuvant Chemoimmunotherapy for Resectable Non-Metastatic Proficient Mismatch Repair PMMR Colon Cancer
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Phase II Open-Label Trial of Neoadjuvant Atezolizumab in Combination With CAPEOX for Resectable Non-Metastatic Proficient Mismatch Repair PMMR Colon Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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 is an open-label Phase II trial that will investigate the use of neoadjuvant CAPEOX chemotherapy with Atezolizumab followed by surgery and adjuvant chemotherapy for patients with localized resectable pMMR adenocarcinoma of the colon with a target accrual of 30 patients
The investigators will explore if appropriately timed neoadjuvant CAPEOX with anti-PD-L1 mAb Atezolizumab can be administered safely and feasibly for 12 weeks and that this combination will lead to improved clinical response associated with enhanced numbers of immune cells in surgically resected colon tumors
Participants will receive 4 cycles of atezolizumab in combination with 4 cycles of CAPEOX atezolizumab will be administered prior to chemotherapy before standard of care surgical resection Each cycle of neoadjuvant therapy is 3 weeks Following surgery participants still considered to be at high-risk of recurrence per NCCN guidelines will receive further adjuvant chemotherapy mFOLFOX6 or CAPEOXfor 6 and 4 cycles respectively for a total of 12 weeks based on the discretion of the treating oncologistinvestigator
Participants will be followed up for an EFFICACY follow-up phase every 2 months during the first 6 months after surgery months 1 3 6 and thereafter participants will enter a SURVIVAL follow-up phase and will be seen every 6 months starting at month 12 until month 36 During this the efficacy and survival follow up visits blood samples will be obtained for purposes of obtaining circulating DNA and stool and optional blood samples for storage for future exploratory analysis Additionally during these follow up visits participants will be asked to complete quality of life questionnaires
The investigators will explore if appropriately timed neoadjuvant CAPEOX with anti-PD-L1 mAb Atezolizumab can be administered safely and feasibly for 12 weeks and that this combination will lead to improved clinical response associated with enhanced numbers of immune cells in surgically resected colon tumors
Participants will receive 4 cycles of atezolizumab in combination with 4 cycles of CAPEOX atezolizumab will be administered prior to chemotherapy before standard of care surgical resection Each cycle of neoadjuvant therapy is 3 weeks Following surgery participants still considered to be at high-risk of recurrence per NCCN guidelines will receive further adjuvant chemotherapy mFOLFOX6 or CAPEOXfor 6 and 4 cycles respectively for a total of 12 weeks based on the discretion of the treating oncologistinvestigator
Participants will be followed up for an EFFICACY follow-up phase every 2 months during the first 6 months after surgery months 1 3 6 and thereafter participants will enter a SURVIVAL follow-up phase and will be seen every 6 months starting at month 12 until month 36 During this the efficacy and survival follow up visits blood samples will be obtained for purposes of obtaining circulating DNA and stool and optional blood samples for storage for future exploratory analysis Additionally during these follow up visits participants will be asked to complete quality of life questionnaires
Detailed Description:
Once participants eligibility has been confirmed and participants have been registered in the study the participants will receive immunotherapy treatment with Atezolizumab followed by administration of CAPEOX chemotherapy for a total of four cycles Each cycle is 3 weeks a total of four cycles will be administered and must be completed within 15 weeks Participants will receive growth factor support at the treating physicians discretion
Participants will receive 4 cycles one cycle every 3 weeks of Atezolizumab along with 4 cycles one cycle every3 weeks of CAPEOX before surgery Atezolizumab will be initiated starting with Cycle 1 Day 1 during first chemotherapy session Trial interventions should begin on the day of enrollment the process of registering or entering a patient into a clinical trial or as close as possible to the date on which intervention is allocatedassigned
Following surgery the treating investigator will monitor and determine the risk of disease recurrence the risk of the cancer coming back after surgery In addition investigators will collect a series of blood sample collections called ctDNA monitoring assay This blood test will be specific to each participant and it may indicate if more chemotherapy is needed after surgery In case participants ctDNA test comes back as positive at any point the investigators will discuss with participant about the possibility of receiving further chemotherapy for an additional 12 weeks This chemotherapy regimen will be either mFOLFOX6 every 2 weeks for a total of 6 cycles 12 weeks or CAPEOX chemotherapy every 3 weeks for a total of 4 cycles 12 weeks Toxicities undesirable effects of medications for Atezolizumab and CAPEOX will be continuously monitored to make sure their side effects are in line with prior experience of their use individually or combined
Re-Staging Staging is a way to describe a cancer The cancers stage tells the investigators where a cancer is located and its size how far it has grown into nearby tissues and if it has spread to nearby lymph nodes a small bean-shaped structure that is part of the bodys immune system or other parts of the body
For this study the investigators will order for participants to have a Computerized Tomography CT a series of X-ray images taken from different angles or a Magnetic Resonance Imaging MRI a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body done before any intervention with the purpose of staging the cancer determining if it is removable by surgery
Restaging with the same method of imaging used to meet initial eligibility requirements including either contrast-enhanced CT or MRI for patients with an intravenous contrast allergy must be performed 2-4 weeks following completion of chemotherapy All re-staging imaging will be centrally reviewed for assessment of resectability to determine if the cancer can be removed
SURGERY After participants have recovered sufficiently from any adverse effects of neoadjuvant chemotherapy and still have removable cancer on re-staging the investigator should proceed to surgery at the participating site within 8 weeks following completion of chemotherapy
ADJUVANT CHEMOTHERAPY Following surgery the treating investigator will monitor and determine the risk of disease recurrence the risk of the cancer coming back after surgery In addition the investigators will collect a series of blood sample collections called ctDNA monitoring assay This blood test will be specific to each participant and it may indicate if more chemotherapy is needed after surgery In case participants ctDNA test comes back as positive at any point the investigator will discuss with participants about the possibility of receiving further chemotherapy for an additional 12 weeks This chemotherapy regimen will be either mFOLFOX6 every 2 weeks for a total of 6 cycles 12 weeks or CAPEOX chemotherapy every 3 weeks for a total of 4 cycles 12 weeks
FOLLOW UP VISITS Participants will be followed up for an efficacy follow-up phase every 2 months during the first 6 months after surgery months 1 3 6 and thereafter they will enter a survival follow-up phase and will be seen every 6 months starting at month 12 until month 36 During these visits the investigators are going to monitor participants blood for ctDNA analysis and whole blood samples for future research analysis vital status updates quality of life questionnaires routine laboratory assessments and standard of care imaging
All screening evaluations must be completed and reviewed to confirm that potential participants meet all eligibility criteria
Participants will receive 4 cycles one cycle every 3 weeks of Atezolizumab along with 4 cycles one cycle every3 weeks of CAPEOX before surgery Atezolizumab will be initiated starting with Cycle 1 Day 1 during first chemotherapy session Trial interventions should begin on the day of enrollment the process of registering or entering a patient into a clinical trial or as close as possible to the date on which intervention is allocatedassigned
Following surgery the treating investigator will monitor and determine the risk of disease recurrence the risk of the cancer coming back after surgery In addition investigators will collect a series of blood sample collections called ctDNA monitoring assay This blood test will be specific to each participant and it may indicate if more chemotherapy is needed after surgery In case participants ctDNA test comes back as positive at any point the investigators will discuss with participant about the possibility of receiving further chemotherapy for an additional 12 weeks This chemotherapy regimen will be either mFOLFOX6 every 2 weeks for a total of 6 cycles 12 weeks or CAPEOX chemotherapy every 3 weeks for a total of 4 cycles 12 weeks Toxicities undesirable effects of medications for Atezolizumab and CAPEOX will be continuously monitored to make sure their side effects are in line with prior experience of their use individually or combined
Re-Staging Staging is a way to describe a cancer The cancers stage tells the investigators where a cancer is located and its size how far it has grown into nearby tissues and if it has spread to nearby lymph nodes a small bean-shaped structure that is part of the bodys immune system or other parts of the body
For this study the investigators will order for participants to have a Computerized Tomography CT a series of X-ray images taken from different angles or a Magnetic Resonance Imaging MRI a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body done before any intervention with the purpose of staging the cancer determining if it is removable by surgery
Restaging with the same method of imaging used to meet initial eligibility requirements including either contrast-enhanced CT or MRI for patients with an intravenous contrast allergy must be performed 2-4 weeks following completion of chemotherapy All re-staging imaging will be centrally reviewed for assessment of resectability to determine if the cancer can be removed
SURGERY After participants have recovered sufficiently from any adverse effects of neoadjuvant chemotherapy and still have removable cancer on re-staging the investigator should proceed to surgery at the participating site within 8 weeks following completion of chemotherapy
ADJUVANT CHEMOTHERAPY Following surgery the treating investigator will monitor and determine the risk of disease recurrence the risk of the cancer coming back after surgery In addition the investigators will collect a series of blood sample collections called ctDNA monitoring assay This blood test will be specific to each participant and it may indicate if more chemotherapy is needed after surgery In case participants ctDNA test comes back as positive at any point the investigator will discuss with participants about the possibility of receiving further chemotherapy for an additional 12 weeks This chemotherapy regimen will be either mFOLFOX6 every 2 weeks for a total of 6 cycles 12 weeks or CAPEOX chemotherapy every 3 weeks for a total of 4 cycles 12 weeks
FOLLOW UP VISITS Participants will be followed up for an efficacy follow-up phase every 2 months during the first 6 months after surgery months 1 3 6 and thereafter they will enter a survival follow-up phase and will be seen every 6 months starting at month 12 until month 36 During these visits the investigators are going to monitor participants blood for ctDNA analysis and whole blood samples for future research analysis vital status updates quality of life questionnaires routine laboratory assessments and standard of care imaging
All screening evaluations must be completed and reviewed to confirm that potential participants meet all eligibility criteria
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?:
True
Is an FDA AA801 Violation?:
None