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Regorafenib + Nivolumab for Colorectal Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Regorafenib and Nivolumab Combination - Escalation
- Group 2: Regorafenib and Nivolumab Combination - Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are researchers currently looking for participants to join this clinical trial?
"At this point in time, no further participants are being sought for the aforementioned trial. Initially posted on October 23rd 2018, it was last updated November 2nd 2022. For those interested in other studies involving colorectal carcinoma, 1265 trials are presently recruiting patients and 762 trials need volunteers to test Nivolumab's efficacy."
Has Nivolumab obtained authorization from the Federal Drug Administration?
"Given the limited clinical information available, Nivolumab's safety rating is 1 on our 3-point scale. This trial is currently in Phase 1 and has yet to generate sufficient data regarding efficacy or safety."
Is there any precedent for the utilization of Nivolumab in medical research?
"Currently, Nivolumab is being studied in 762 active clinical trials with 87 of those studies entering Phase 3. Basel, BE hosts the greatest number of these experiments; however, other 41034 sites around the world are also conducting research on this medication."
How many participants are eligible to partake in this experiment?
"Recruitment for this trial has ceased. The initial post was published on October 23rd 2018 and the most recent update occured November 2nd 2022. Those searching for related studies can view 1265 trials actively accepting enrollees with colorectal carcinoma, as well as 762 clinical trials that are utilizing Nivolumab to treat their patients at present."
Is this a pioneering research endeavor?
"Nivolumab has been the subject of inquiry since 2012 when Ono Pharmaceutical Co. Ltd first conducted a study with 659 participants. After demonstrating positive results in Phase 1 & 2 trials, 762 live experiments are currently being run across 2449 cities and 50 countries."
What maladies or diseases can Nivolumab be utilized to address?
"The immunotherapy drug, Nivolumab, has been proven effective in treating malignant neoplasms, irresectable melanoma, and squamous cell carcinoma."
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