Study on Regorafenib and Pembrolizumab for Treating Advanced or Metastatic Colorectal Cancer
Sponsor: University of Southern California
ClinicalTrials ID:NCT03657641
This clinical trial is testing a combination of two drugs, regorafenib and pembrolizumab, to see if they can safely and effectively treat colorectal cancer that has spread to other parts of the body. The study aims to find the best dose and understand how well these drugs work together.
Patient Parameters
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Program Overview
This study is exploring the effects of combining two drugs, regorafenib and pembrolizumab, to treat colorectal cancer that has advanced or spread to other areas. Regorafenib is a chemotherapy drug that works by stopping cancer cells from growing and spreading, while pembrolizumab is an antibody that helps the immune system attack cancer cells. The study will determine the safest and most effective dose of this combination and evaluate its ability to control the cancer.
Description
The study is divided into two phases. In Phase I, researchers will determine the safest dose of regorafenib when used with pembrolizumab. In Phase II, they will assess how well this combination works in treating colorectal cancer. Participants will receive pembrolizumab through an IV on the first day and take regorafenib pills daily for 14 days. This cycle repeats every 21 days as long as the treatment is effective and side effects are manageable. After completing the treatment, participants will have regular follow-up visits to monitor their health and the cancer's response.
Eligibility Criteria
Inclusion Criteria
- Must have advanced or metastatic colorectal cancer that has not responded to previous treatments like oxaliplatin, irinotecan, and fluorouracil (5-FU).
- Must be able to take oral medication.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have measurable cancer lesions according to standard criteria.
- Must have adequate blood cell counts and organ function, including:
- Neutrophil count of at least 200/mm^3.
- Platelet count of at least 75,000/mm^3.
- Liver enzymes and bilirubin levels within specified limits.
- Kidney function within specified limits.
- Women of childbearing potential must agree to use effective contraception during and for 23 weeks after treatment.
- Men must agree to use contraception during and for 31 weeks after treatment.
Exclusion Criteria
- Have received chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy within 2 weeks before joining the study.
- Have previously taken regorafenib.
- Have uncontrolled high blood pressure despite treatment.
- Have had a heart attack or unstable chest pain within 6 months before joining the study.
- Have large fluid buildup in the chest or abdomen requiring frequent drainage.
- Have an active infection or symptomatic brain metastasis.
- Have gastrointestinal obstruction or active lung disease.
- Test positive for HIV, hepatitis B, or hepatitis C.
- Have an autoimmune disease or require systemic corticosteroids or immunosuppressants.
- Have severe heart failure or a seizure disorder requiring medication.
- Have significant protein in the urine or a history of bleeding disorders.
- Are pregnant or breastfeeding, or have the potential for pregnancy without using contraception.
- Are taking certain medications that interact with the study drugs or have received a live vaccine recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope | 91010 | Duarte | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
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