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Cibisatamab + Atezolizumab for Colorectal Cancer
Study Summary
This trial is looking at a new colorectal cancer treatment combining two drugs, cibisatamab and atezolizumab, given after pretreatment with obinutuzumab. The trial will assess the safety and efficacy of this combination therapy and will enroll patients who have Stage IV microsatellite stable metastatic colorectal cancer and high carcinoembryonic antigen-related cell adhesion molecule 5 expression.
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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Who is running the clinical trial?
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- I am fully active or can carry out light work.You are expected to live for at least 12 more weeks.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.I have trouble breathing or low oxygen levels due to lung cancer.My cancer has spread and cannot be treated with surgery or radiation.I have not been treated with specific immune therapies like TCBs or checkpoint inhibitors.I have not been treated with regorafenib or TAS-102.My spinal cord compression hasn't been treated or wasn't stable for 2 weeks before starting the study treatment.My tumor shows high levels of a specific protein marker.I haven't had cancer treatment, like chemotherapy, in the last 28 days.My blood and organs are functioning well.I do not have any health conditions that would make it unsafe for me to take a new drug.I have had a previous transplant of stem cells or an organ.My condition worsened within 3 months after my last standard treatment.I have had lung conditions like pulmonary fibrosis or pneumonitis, or my chest scan shows active pneumonitis.I have not received a live vaccine within the last 4 weeks and do not plan to during or within 5 months after the study.I haven't had cancer, other than colorectal, in the last 5 years, except for certain low-risk types.I agree to use contraception or remain abstinent and not donate sperm during and for 3 months after treatment.My cancer is a type of colon or rectal cancer confirmed by a biopsy.I have high calcium levels in my blood that are causing symptoms.I have severe cancer pain or fluid buildup needing frequent draining.I have more than 10 lung lesions across both lungs.My lung cancer has spread in a specific pattern throughout my lungs.I agree to use contraception or remain abstinent and not donate sperm during and for 3 months after treatment.I have large tumors in areas where swelling could cause serious problems.I have had leptomeningeal disease and progressive multifocal leukoencephalopathy.I have brain metastases that are untreated or getting worse.I do not have severe heart problems like uncontrolled high blood pressure, recent heart attacks, or serious irregular heartbeats.My condition worsened within 3 months after my last standard treatment.I have tested negative for hepatitis B or have a controlled infection.My cancer is a type of colon or rectal cancer confirmed by a lab test.My blood and organs are functioning well.I need procedures to remove fluid from my chest.I have fluid or lesions in the lining of both my lungs.I do not have any active infections or recent major infections needing hospital care.I have had tuberculosis treatment within the last 3 years.I have fluid around my heart.I am currently on medication for hepatitis B.I haven't taken any immune-weakening drugs in the last 2 weeks and don't expect to need any during the study.My cancer has spread and cannot be treated with surgery or radiation.I am fully active or can carry out light work.My tumor shows high levels of a specific protein, confirmed by a test.I have tested negative for hepatitis B or have cleared the virus.My tumor is not highly variable at the genetic level.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.My side effects from previous cancer treatments are mild, except for hair loss or mild nerve issues.My tumor is not highly variable at the genetic level.
- Group 1: Obinutuzumab Pretreatment (OpT) + Cibisatamab + Atezolizumab
- 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
What other experiments have employed Cibisatamab to analyze its efficacy?
"Currently, there are 498 active trials exploring cibisatamab's efficacy and safety. Of those studies, 95 have reached Phase 3 of the trial process. Although most research is centred in Harvey, Illinois, Cibisatamab is being tested at over 24000 locations worldwide."
What are the safety implications associated with Cibisatamab use?
"Due to the limited clinical data available on Cibisatamab, our experts assigned it a safety score of 1. This is because this drug is still being tested in Phase 1 trials and its efficacy has yet to be seen."
Has a similar endeavor been attempted prior to this venture?
"At present, 498 Cibisatamab studies are being conducted across 82 countries and 1935 cities. The initial clinical trial for this drug was carried out by Hoffmann-La Roche in 2008 and included 720 patients. This study achieved Phase 2 FDA approval before concluding; since then a further 348 similar trials have been completed worldwide."
Would this research endeavor be open to new participants?
"Per the clinical trials website, this medical research project is presently inactive with regards to recruiting volunteers. It was first posted on May 7th 2019 and last updated October 28 2022. Fortunately for those interested in participating in a trial, there are 1,852 other studies currently searching for patients."
What therapeutical applications is Cibisatamab employed for?
"Cibisatamab may be effective in treating small cell lung cancer, systemic juvenile idiopathic arthritis, and certain malignant neoplasms."
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