Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-03 @ 7:24 AM
Study NCT ID:
NCT02873195
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Capecitabine and Bevacizumab With or Without Atezolizumab in Treating Patients With Refractory Metastatic Colorectal Cancer
Sponsor:
Academic and Community Cancer Research United
Organization:
Study Overview
Official Title:
BACCI: A Phase II Randomized, Double-Blind, Placebo-Controlled Study of Capecitabine Bevacizumab Plus Atezolizumab Versus Capecitabine Bevacizumab Plus Placebo in Patients With Refractory Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2024-07
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 randomized phase II trial studies how well capecitabine and bevacizumab with or without atezolizumab work in treating patients with colorectal cancer that is not responding to treatment and has spread to other places. Immunotherapy with monoclonal antibodies, such as atezolizumab and bevacizumab, may help the body?s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab with capecitabine and bevacizumab may be a better way in treating colorectal cancer.
Detailed Description:
PRIMARY OBJECTIVE:
I. To estimate the efficacy of capecitabine/bevacizumab + atezolizumab, as compared with capecitabine/bevacizumab + placebo in refractory metastatic colorectal cancer (mCRC) as measured by progression-free survival (defined as the time of randomization to the first occurrence of progression based on Response Evaluation Criteria in Solid Tumors version 1.1, clinical progression, or death from any cause on study as determined by the investigator).
SECONDARY OBJECTIVES:
I. To estimate the efficacy of capecitabine/bevacizumab + atezolizumab, as compared with capecitabine/bevacizumab + placebo in refractory mCRC as measured by objective response rate (defined as partial response plus complete response) as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 and immune-related response criteria (irRC).
II. To estimate the efficacy of capecitabine/bevacizumab + atezolizumab as compared with capecitabine/bevacizumab + placebo in refractory mCRC as measured by overall survival (defined as death from any cause from the time of randomization until study completion).
III. To evaluate the safety and tolerability of atezolizumab in combination with bevacizumab and capecitabine in refractory mCRC as measured by the serious adverse events and adverse events \>= grade 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
CORRELATIVE OBJECTIVE:
I. To explore any correlation between tissue and blood based biomarkers and clinical outcomes.
OUTLINE: Patients are randomized 2:1 to Arm I:Arm II.
ARM I (ATEZOLIZUMAB, BEVACIZUMAB, CAPECITABINE): Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II (PLACEBO, BEVACIZUMAB, CAPECITABINE): Patients receive placebo IV over 30-60 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3 months until progressive disease, then every 6 months thereafter.
I. To estimate the efficacy of capecitabine/bevacizumab + atezolizumab, as compared with capecitabine/bevacizumab + placebo in refractory metastatic colorectal cancer (mCRC) as measured by progression-free survival (defined as the time of randomization to the first occurrence of progression based on Response Evaluation Criteria in Solid Tumors version 1.1, clinical progression, or death from any cause on study as determined by the investigator).
SECONDARY OBJECTIVES:
I. To estimate the efficacy of capecitabine/bevacizumab + atezolizumab, as compared with capecitabine/bevacizumab + placebo in refractory mCRC as measured by objective response rate (defined as partial response plus complete response) as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 and immune-related response criteria (irRC).
II. To estimate the efficacy of capecitabine/bevacizumab + atezolizumab as compared with capecitabine/bevacizumab + placebo in refractory mCRC as measured by overall survival (defined as death from any cause from the time of randomization until study completion).
III. To evaluate the safety and tolerability of atezolizumab in combination with bevacizumab and capecitabine in refractory mCRC as measured by the serious adverse events and adverse events \>= grade 3 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
CORRELATIVE OBJECTIVE:
I. To explore any correlation between tissue and blood based biomarkers and clinical outcomes.
OUTLINE: Patients are randomized 2:1 to Arm I:Arm II.
ARM I (ATEZOLIZUMAB, BEVACIZUMAB, CAPECITABINE): Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine orally (PO) twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II (PLACEBO, BEVACIZUMAB, CAPECITABINE): Patients receive placebo IV over 30-60 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 3 months until progressive disease, then every 6 months thereafter.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2016-01263 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| RU021416I | OTHER | Academic and Community Cancer Research United | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |