Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03657641|
Recruitment Status : Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : May 2, 2019
|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|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 1, 2022|
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
|Contact: Xiomara Menendez, RN||323-409-4368||Xiomara.Menendez@med.usc.edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Not yet recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Xiomara Menendez, RN 323-409-4368 Xiomara.Menendez@med.usc.edu|
|Principal Investigator: Afsaneh Barzi, MD|
|Hoag Memorial Hospital||Not yet recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Alicia L. Bogardus, MA Alicia.firstname.lastname@example.org|
|Principal Investigator: Diana L. Hanna, MD|
|United States, Florida|
|Moffitt Cancer Center||Not yet recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Richard D. Kim, MD Richard.Kim@moffitt.org|
|Principal Investigator: Richard D. Kim, MD|
|Principal Investigator:||Afsaneh Barzi, MD||University of Southern California|