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Pembrolizumab + Capecitabine + Bevacizumab for Colorectal Cancer
Study Summary
This trial is studying capecitabine, pembrolizumab, and bevacizumab to see how well they work in treating patients with colorectal cancer that has spread to nearby tissues or lymph nodes, has spread to other places in the body, or that cannot be removed by surgery.
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.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- My condition didn't improve or worsened after treatment with 5-FU or capecitabine.My organs are working well, as tested within the last 10 days.I am at least 18 years old.I can provide a recent biopsy sample or an older one with approval, and I am mostly active.You have a mental health condition or problems with drugs or alcohol that could make it difficult for you to follow the study requirements.I have another cancer that is getting worse or needs treatment.I have issues swallowing or absorbing medication due to a gastrointestinal condition.I have not received a live vaccine in the last 30 days.My colorectal cancer is advanced and cannot be removed by surgery.My colorectal cancer is not highly mutated (MSS) or has normal mismatch repair proteins (pMMR).I am fully active or restricted in physically strenuous activity but can do light work.I am willing to use birth control for 4 months after my last dose.I am a man who can father a child and agree to use contraception for 120 days after my last dose.I haven't taken steroids or immunosuppressants in the last 7 days.I have an active case of tuberculosis.I am not allergic to pembrolizumab, capecitabine, 5-FU, or bevacizumab.I haven't had any cancer antibody treatments in the last 4 weeks or still have side effects from them.I have cancer that has spread to my brain or spinal cord.I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks and have recovered from any side effects.I haven't had any major abdominal issues like fistulas, perforations, or abscesses in the last 6 months.I do not have an active infection needing treatment when starting the trial.I don't have any health issues that could affect the trial's results or my participation.I have a bleeding disorder or had significant bleeding in the last year.I haven't had severe bleeding in the last 6 months.I have not had a blood clot in an artery in the past year.I haven't had a severe hypertension crisis or brain issues due to high blood pressure in the last 6 months.You must agree to and sign a document stating that you understand the trial and agree to participate in it.I am willing to provide a new tissue sample from my tumor for the study.My colorectal cancer is not microsatellite instability-high (MSI-H).I am a woman who can have children and have a negative pregnancy test.My cancer did not improve or worsened after treatment with 5-FU or capecitabine.I have been diagnosed with reversible posterior leukoencephalopathy syndrome.I am at least 18 years old.My high blood pressure is not well controlled.I am currently in a clinical trial or was in one within the last 4 weeks.You have a medical condition that can be measured using a specific guideline called RECIST 1.1.I haven't had major heart issues in the last year.I have or had lung inflammation that needed steroids.Your platelet count is at least 100,000 per microliter.I have had wounds or ulcers that didn't heal, or bones that broke again within 3 months.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.My hemoglobin level is stable without needing transfusions or EPO.I am on warfarin for blood clot prevention.I haven't had serious bleeding or surgery in the recent months.You have enough white blood cells called neutrophils, with a count of at least 1,500 per microliter of blood.I have an autoimmune disease treated with medication in the last 2 years.I have active hepatitis B or C.My colorectal cancer is advanced and cannot be surgically removed.I have been diagnosed with HIV.
- Group 1: Treatment (pembrolizumab, bevacizumab, capecitabine)
- 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
Has Pembrolizumab obtained authorization from the FDA?
"Clinical evidence suggests that pembrolizumab has a relative safety rating of 2, as it is currently in the second phase trial and there are no current reports suggesting its efficacy."
Are researchers recruiting for this experiment at the present moment?
"Unfortunately, no new candidates are being accepted as of now. This clinical trial was first posted on April 18th 2018 and its last update occurred on May 16th 2022. If you're still in search of other studies, 860 trials related to colorectal carcinoma and 1571 trials involving Pembrolizumab are actively recruiting participants."
For what therapeutic applications is pembrolizumab regularly employed?
"Pembrolizumab can be a viable treatment option for individuals suffering from malignant neoplasms, unresectable melanoma, and cases of microsatellite instability high."
What are the desired outcomes of this research?
"This clinical trial, expected to last up to 4 years, seeks to assess the frequency of treatment-related dose-limiting toxicities (DLT). Secondary goals include evaluating disease control rate (DCR) with exact binomial methods proposed by Clopper and Pearson (1934), progression-free survival (PFS) through Kaplan-Meier curves, as well as overall survival rates."
Has Pembrolizumab been examined in any other research projects?
"At the moment, a grand total of 1571 medical studies have been initiated to investigate Pembrolizumab. Of these active trials, 318 are in their concluding Phase 3. Although most investigations into this treatment take place in Guangzhou, Guangdong, there are over 61 thousand sites worldwide testing it."
Are there any limits to the number of individuals enrolled in this experiment?
"This study is not currently accepting patients. It was first posted on April 18th 2018 and last updated on May 16th 2022. If you are seeking alternative trials, 860 studies involving colorectal carcinoma have vacancies and 1571 Pembrolizumab-based experiments are actively recruiting participants."
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