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Checkpoint Inhibitor
Regorafenib + Nivolumab for Colorectal Cancer
Phase 1
Waitlist Available
Led By Dae W Kim, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1
Received and progressed through or become intolerant to specified therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months after conclusion of treatment
Awards & highlights
Study Summary
This trial is testing the safety and side effects of a combination of two drugs, Regorafenib and Nivolumab, in people with metastatic colorectal cancer. Researchers want to find out if this combination can help people with a certain type of cancer, called metastatic colorectal cancer with mismatch repair (MMR) proficiency.
Who is the study for?
This trial is for adults with colorectal cancer that's spread and doesn't respond to standard treatments. They should be relatively healthy otherwise, able to perform daily activities with little or no help (ECOG score 0-1), and have not had certain other treatments recently. Women who can have children must test negative for pregnancy and use birth control, as must men.Check my eligibility
What is being tested?
Researchers are testing the combination of two drugs, Regorafenib and Nivolumab, to find the safest high dose for metastatic colorectal cancer patients whose tumors repair DNA normally (MMR proficient). The goal is also to see if this drug combo helps against their cancer.See study design
What are the potential side effects?
Possible side effects include fatigue, weakness, high blood pressure, hand-foot skin reactions from Regorafenib; immune-related issues like inflammation in organs or skin problems from Nivolumab. Each person may experience side effects differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My condition worsened or I couldn't tolerate my previous treatments.
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My diagnosis is colorectal cancer confirmed by tissue analysis.
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I am capable of becoming pregnant and have a negative pregnancy test.
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My cancer has normal DNA repair ability or stable genes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months after conclusion of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months after conclusion of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose
Secondary outcome measures
Frequency and Severity of Adverse Events
Overall Survival (OS)
Response Rate
Trial Design
2Treatment groups
Experimental Treatment
Group I: Regorafenib and Nivolumab Combination - ExpansionExperimental Treatment2 Interventions
Dose Expansion: To find the effect on tumor of the combination of regorafenib and nivolumab.
Group II: Regorafenib and Nivolumab Combination - EscalationExperimental Treatment2 Interventions
Dose Escalation: To find the dose of regorafenib that can be safely given with nivolumab in patients with advanced, refractory colorectal cancers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1580
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
547 Previous Clinical Trials
135,560 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,780 Total Patients Enrolled
Dae W Kim, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
23 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a heart condition that affects my daily life.My bone marrow, liver, and kidneys are functioning well.I am fully active or can carry out light work.I am not allergic to the study drugs or their ingredients.My blood pressure is not controlled by medication.My condition worsened or I couldn't tolerate my previous treatments.I have not had severe bleeding in the last 4 weeks.I need to take medication or hormone therapy for my cancer.My diagnosis is colorectal cancer confirmed by tissue analysis.I have brain metastases but have been stable for 2 weeks after treatment.I have not had a clot in my arteries in the last 6 months.I haven't had chemotherapy, major surgery, or certain therapies in the last 21 days.I have severe protein in my urine.I have received an organ transplant from another person.I have severe liver disease or had a stroke or brain bleed in the last 6 months.I have HIV or chronic hepatitis B or C.I am capable of becoming pregnant and have a negative pregnancy test.I have previously been treated with specific antibodies.I am not taking warfarin or strong drugs that affect liver enzymes.I have side effects from previous treatments that are not severe.My cancer has normal DNA repair ability or stable genes.I do not have conditions like fluid buildup, ongoing infections, or lung disease.I have not had major surgery or any unhealed wounds in the last 4 weeks.You are expected to live for at least 3 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Regorafenib and Nivolumab Combination - Escalation
- Group 2: Regorafenib and Nivolumab Combination - Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT03712943 — Phase 1
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