Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03657641|
Recruitment Status : Active, not recruiting
First Posted : September 5, 2018
Last Update Posted : August 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Cancer Metastatic||Biological: Pembrolizumab Drug: Regorafenib||Phase 1 Phase 2|
I. To assess safety of the combination and identification of the recommended dose (RD) for combination therapy. (Phase I) II. To evaluate preliminary efficacy and tolerability of the combination RD of regorafenib and pembrolizumab. (Phase II)
I. The associations between biomarkers and clinical outcome will be investigated.
OUTLINE: This is a phase I, dose-escalation study of regorafenib followed by a phase II study.
Participants receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and regorafenib orally (PO) once daily (QD) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Regorafenib and Pembrolizumab in Metastatic Colorectal Cancer Patients in 3rd and 4th Line Setting|
|Actual Study Start Date :||June 21, 2019|
|Estimated Primary Completion Date :||June 21, 2023|
|Estimated Study Completion Date :||June 21, 2024|
Experimental: Treatment (pembrolizumab, regorafenib)
Participants receive pembrolizumab IV over 30 minutes on day 1 and regorafenib PO QD on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- Dose limiting toxicity (DLTs) (Phase I) [ Time Frame: At the end of Course 1 (each course is 21 days) ]Will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03. All DLTs will be listed by dose level.
- Progression-free survival (PFS) (Phase II) [ Time Frame: Up to 30 months after study entry ]PFS will be calculated from the start of treatment (day 1 of cycle 1) to the first observation of disease progression or death whichever comes first, or to the latest follow up. Kaplan Meier curves will be used for PFS plot. Medians and probabilities of PFS at 3 and 6 months and their 95% CI confidence intervals will be given.
- Overall survival (OS) [ Time Frame: Up to 30 months after study entry ]OS will be calculated from the start of treatment (day 1 or cycle 1) to death from any cause. Kaplan Meier curves will be used to OS plot. Medians and probabilities at 3 and 6 months and their 95%CI confidence intervals will be given.
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): NCT03657641
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Hoag Memorial Hospital|
|Newport Beach, California, United States, 92663|
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Afsaneh Barzi, MD||University of Southern California|