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Triple Drug Therapy for Colorectal Cancer
Study Summary
This trial is testing a new combination of drugs for people with metastatic colorectal adenocarcinoma who have not responded to other treatments.
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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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- My colorectal cancer cannot be removed by surgery and has spread.My colorectal cancer has worsened after two treatments.I agree to use birth control or remain abstinent and not donate sperm for 6 months after treatment ends.My colorectal cancer cannot be removed by surgery and has spread.I am fully active or restricted in physically strenuous activity but can do light work.I have taken bevacizumab before.You must agree to have tissue samples taken before and after treatment. The doctor will make sure the procedure is safe for you.You are willing and able to follow the study's rules, according to the researcher's opinion.I am willing to have biopsies before and after treatment.I am 18 years old or older.I am 18 years old or older.My cancer can be measured by standard health scans.My previous use of bevacizumab does not affect my eligibility.My blood and organ tests are normal before starting the study drug.You cannot participate if you have a certain type of genetic marker called MSI-high or if you have a specific mutation in your BRAF gene. You also can't participate if you've had surgery or a major injury in the past 60 days, have untreated brain metastases, or have had radiation therapy within 14 days of the start of the study. Additionally, you can't take part if you've had certain types of cancer in the past 3 years, or if you have certain uncontrolled symptoms like pain or fluid buildup. Finally, you can't participate if you're currently taking any experimental or approved treatments.I do not have an autoimmune disease, nor have I needed treatment for one in the last 2 years.I do not have an active infection needing IV antibiotics, hepatitis B or C, HIV, and I follow flu shot guidelines.I do not have a history of eye diseases related to the retina.You cannot participate in the study if you have taken certain medications such as aspirin, clopidogrel, or anticoagulants recently, or had severe allergic reactions to certain types of drugs. You also cannot participate if you are allergic to specific components of Binimetinib, Pembrolizumab, or bevacizumab, or have received certain types of treatments in the past. Additionally, if you have a weakened immune system, or are taking medication to suppress your immune system, you are not eligible for the study.You can sign and date the consent form.My colorectal cancer has worsened after two treatments.I can carry out all my daily activities without help.Your white blood cell count should be between 2.5 and 15.0 billion cells per liter.
- Group 1: Cohort A
- Group 2: Safety run-in
- Group 3: Cohort B
- 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
To what extent are Pembrolizumab, Bevacizumab, and Binimetinib safe for human consumption?
"Our internal evaluation gave Pembrolizumab, Bevacizumab, and Binimetinib a score of two due to the data that suggests their safety but lack of evidence for efficacy in this phase 2 trial."
What is the aggregate sum of participants in this study?
"The aforementioned clinical trial has concluded, having been first posted on September 17th 2018 and last updated May 12th 2022. For those seeking to enroll in other trials investigating colorectal cancer, there are currenly 1,213 studies recruiting patients; likewise for Pembrolizumab, Bevacizumab, and Binimetinib treatments the number stands at 1,343 active enrolment opportunities."
What maladies are Pembrolizumab, Bevacizumab, and Binimetinib usually deployed to combat?
"Pembrolizumab, Bevacizumab, and Binimetinib are typical treatments for unresectable melanoma. It has also been found to be beneficial in the management of microsatellite instability high, locally advanced nonsquamous non-small cell lung cancer, and patients with a heightened risk of recurrence."
What have prior investigations revealed regarding the efficacy of Pembrolizumab, Bevacizumab, and Binimetinib?
"Currently, 1343 clinical trials related to the drugs Pembrolizumab, Bevacizumab, and Binimetinib are active worldwide. Of those studies 209 have reached Phase 3 status. Primarily located in Rochester Minnesota is a multitude of medical centres conducting these investigations; yet there exists 54656 research sites globally running such tests."
Do I meet the criteria to participate in this scientific experimentation?
"This medical trial is searching for 53 individuals of 18 years or older who have been diagnosed with colorectal cancer. To be considered eligible, the applicant must agree to sign a consent form and fulfil additional prerequisites such as: having an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; biopsy-confirmed unresectable metastatic adenocarcinoma; progression on at least two prior therapies; white blood cell count between 2.5 and 15 × 109/L, among others."
Are there any remaining vacancies for participants in this research endeavor?
"This research project has concluded its recruitment phase. The trial commenced on the 17th of September 2018 and was last updated on May 12th 2022. If seeking alternate studies, presently there are 1,213 clinical trials open to colorectal cancer patients and 1,343 admitting participants for Pembrolizumab, Bevacizumab, or Binimetinib treatments."
Does this trial encompass individuals beyond the age of eighty-five?
"This trial is open to volunteers aged 18 up to the age of 99. For minors and seniors, there are 105 trials for those under 18 years old and 2518 studies that cater to individuals over 65."
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