Pembrolizumab, Capecitabine, and Bevacizumab in Treating Patients With Microsatellite Stable Colorectal Cancer That Is Locally Advanced, Metastatic, or Cannot Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT03396926|
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Microsatellite Stable Mismatch Repair Protein Proficient Stage III Colorectal Cancer AJCC v7 Stage IIIB Colorectal Cancer AJCC v7 Stage IIIC Colorectal Cancer AJCC v7 Stage IV Colorectal Cancer AJCC v7 Stage IVA Colorectal Cancer AJCC v7 Stage IVB Colorectal Cancer AJCC v7||Biological: Bevacizumab Drug: Capecitabine Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pembrolizumab Plus Capecitabine and Bevacizumab in Microsatellite Stable Metastatic Colorectal Cancer|
|Actual Study Start Date :||April 18, 2018|
|Estimated Primary Completion Date :||January 3, 2022|
|Estimated Study Completion Date :||January 1, 2023|
Experimental: Treatment (pembrolizumab, bevacizumab, capecitabine)
Patients receive pembrolizumab IV over 30 minutes on day 1, bevacizumab IV over 30-90 minutes on day 1, and capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 35 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Frequency of treatment-related, dose-limiting toxicities (DLT) (Safety Lead-In Cohort) [ Time Frame: Up to 4 years ]A DLT evaluation of the first 6 patients will be conducted to confirm the safety of administering pembrolizumab at 200 mg (flat dosing) every three weeks with capecitabine and bevacizumab and follows the principles of standard 3+3 dose escalation studies. The All Subjects as Treated (ASaT) population will be used for the analysis of safety data in this study. The ASaT population consists of all allocated subjects who received at least one dose of study treatment. At least one laboratory or vital sign measurement obtained subsequent to at least one dose of study treatment is required for inclusion in the analysis including a baseline measure
- Overall response rate (ORR) (Expansion Cohort) [ Time Frame: Up to 4 years ]ORR is defined as the proportion of the subjects in the analysis population who have a complete response (CR) or partial response (PR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The point estimate and 95% confidence interval, will be provided using exact binomial method proposed by Clopper and Pearson (1934).
- Disease control rate (DCR) (Expansion Cohort) [ Time Frame: Up to 4 years ]DCR is defined as the percentage of subjects who have achieved confirmed CR or PR or have demonstrated stable disease (SD) for at least 24 weeks prior to any evidence of progression assessed by RECIST and immune-related RECIST (irRECIST). The point estimate and 95% confidence interval, will be provided using exact binomial method proposed by Clopper and Pearson (1934).
- Duration of response (DOR) (Expansion Cohort) [ Time Frame: Up to 4 years ]Duration of response is defined as the time from first documented evidence of CR or PR assessed by RECIST and irRECIST until disease progression or death due to any cause, whichever occurs first. Kaplan-Meier (KM) curves and median estimates from the KM curves will be provided as appropriate.
- Overall survival (OS) (Expansion Cohort) [ Time Frame: Up to 4 years ]OS is defined as the time from first day of study treatment to death due to any cause. Subjects without documented death at the time of the final analysis will be censored at the date of the last follow-up. KM curves and median estimates from the KM curves will be provided as appropriate.
- Progression-free survival (PFS) (Expansion Cohort) [ Time Frame: Up to 4 years ]PFS is defined as the time from first day of study treatment to the first documented disease progression or death due to any cause, whichever occurs first. KM curves and median estimates from the KM curves will be provided as appropriate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396926
|Contact: Madeline Griffithemail@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Madeline Griffith 877-827-3222 firstname.lastname@example.org|
|Principal Investigator: Chloe E. Atreya, MD, PhD|
|Principal Investigator:||Chloe Atreya, MD, PhD||University of California, San Francisco|