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Tyrosine Kinase Inhibitor
Regorafenib + XmAb20717 for Colorectal Cancer
Phase 2
Waitlist Available
Led By Kanwal Raghav, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological confirmation of CRC
Post-R0 resection of stages II, III, or IV CRC and all planned adjuvant therapies have been completed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial measures the amount of tumor DNA in the blood of colorectal cancer patients after treatment with two drugs.
Who is the study for?
This trial is for adults over 18 with colorectal cancer who've had surgery to remove their tumor and finished any other treatments. They must have signs of microscopic cancer left, as shown by a ctDNA test, good organ function, no recent major surgeries or serious illnesses, and not be on immunosuppressants. Women who can get pregnant and men must agree to use birth control during the study.Check my eligibility
What is being tested?
The trial tests Regorafenib and XmAb20717 (vudalimab) in patients with high-risk colorectal cancer showing no visible tumors but positive for ctDNA. The goal is to see if these drugs can reduce or eliminate this molecular residual disease after six months of treatment.See study design
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, hand-foot skin reactions from Regorafenib; immune-related issues like inflammation in organs due to XmAb20717 could also occur. Both drugs may cause liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My colorectal cancer has been confirmed through tissue examination.
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I've completed all treatments after surgery for stage II-IV colon cancer.
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My kidney function, measured by creatinine clearance, is sufficient.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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I have not had a menstrual period for at least 12 months.
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I have had a hysterectomy or both ovaries removed.
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I have ovarian failure due to radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Regorafenib and XmAb20717Experimental Treatment2 Interventions
Participants will receive regorafenib and XmAb20717 for up to 6 cycles (6 months). Participants will take regorafenib by mouth on Days 1-21 of each cycle. Participants will rest (not take regorafenib) on Days 21-28 of each cycle. Participants will also receive XmAb20717 by vein on Days 1 and 15 of each cycle. Each infusion should take about 60 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1580
XmAb20717
2018
Completed Phase 1
~150
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,474 Total Patients Enrolled
Xencor, Inc.Industry Sponsor
29 Previous Clinical Trials
2,753 Total Patients Enrolled
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,777 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken immunosuppressive drugs in the last 7 days or experimental drugs in the last 28 days.I do not have any uncontrolled illnesses that could affect my participation.I have not had any other cancer besides the one being studied in the last 3 years.I have not had a menstrual period for at least 12 months.I agree to use birth control during and 4 months after the study if I can have children.I am using or willing to use approved birth control methods during the trial.I have not had any organ transplants that require me to take immunosuppressants.I am not on any medication that could badly interact with the study drug, and I have not had major surgery or a serious injury in the last 21 days.I haven't had a stroke, heart attack, severe chest pain, serious heart failure, or dangerous irregular heartbeat in the last 6 months.I have not received a live-virus vaccine in the last 30 days.I do not have severe protein leakage in my urine.My blood pressure is very high (over 160/100).My cancer shows signs of minimal residual disease (MRD) through a blood test.I am 18 years old or older.I have recovered from previous cancer treatment side effects, except for immune-related ones, to a mild level.I haven't had serious infections like HIV, hepatitis, or fungal infections in the last 30 days.I've completed all treatments after surgery for stage II-IV colon cancer.My colorectal cancer has been confirmed through tissue examination.My organs and bone marrow are working well.My scans showed no cancer signs within 28 days of a positive blood test for cancer.I have had a hysterectomy or both ovaries removed.I have ovarian failure due to radiation therapy.My kidney function, measured by creatinine clearance, is sufficient.I am fully active or restricted in physically strenuous activity but can do light work.I have had lung inflammation treated with steroids or have a lung condition.I have severe allergies to certain medications or uncontrolled asthma recently.I have an autoimmune disease that could worsen with immune-boosting treatments.I have previously been treated with drugs that boost the immune system to fight my colorectal cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Regorafenib and XmAb20717
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any remaining slots for this medical experiment available to participants?
"As per clinicaltrials.gov, this initiative has concluded its recruitment process - it was initially posted on November 30th 2023 and last updated on May 31st 2023. However, 1499 other trials are still looking for volunteers at the present time."
Answered by AI
Have the U.S. Food and Drug Administration (FDA) accepted Regorafenib and XmAb20717 for public use?
"Regorafenib and XmAb20717 have been deemed safe in Phase 2 trials, thus garnering a score of 2. However, no data from this phase has proven their efficacy yet."
Answered by AI
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