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Bevacizumab + Atezolizumab +/- Cobimetinib for Melanoma Brain Metastases
Study Summary
This trial is studying how well bevacizumab and atezolizumab work in treating patients with untreated melanoma that has spread to the brain, with or without cobimetinib.
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 2015 Phase 4 trial • 45 Patients • NCT02036424Trial Design
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Who is running the clinical trial?
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- You are not expected to live for more than 12 weeks.I have active tuberculosis.I have not had severe infections in the last 4 weeks.I have not received a live vaccine in the last 4 weeks.I can take care of myself and am up and about more than half of my waking hours.Your blood clotting time is within normal limits.You have high levels of protein in your urine, shown by a UPC ratio of 1.0 or higher.You are expected to live for more than 12 weeks.I haven't needed steroids for 10 days, or I'm on a low dose for brain-related symptoms.I've had treatments for melanoma spread outside the brain but not with PD-1/PD-L1 inhibitors.I can provide tumor samples with a pathology report for PD-L1 testing.Your blood test results need to be within certain ranges.I have no autoimmune, lung, infectious diseases, or metabolic issues.I have not had signs of infection in the last 2 weeks.I have a serious wound, ulcer, or untreated bone fracture that is not healing.I have not had a gut perforation or abnormal connection within the last 6 months.I am 18 years old or older.My side effects from cancer treatment are mild, except for hair loss.I am allergic to bevacizumab, atezolizumab, or cobimetinib.I have not been excluded due to issues with cobimetinib.My melanoma does not have the BRAFV600 mutation.I have not had any other cancers in the last 5 years.I have a brain tumor that can be measured.I haven't had any cancer treatment, including chemotherapy or hormonal therapy, in the last 3 weeks.I have not had treatments or conditions that conflict with atezolizumab and bevacizumab.I have a history of HIV or active hepatitis B/C.
- Group 1: Arm I (atezolizumab, bevacizumab)
- Group 2: Arm II (atezolizumab, bevacizumab, cobimetinib)
- 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 past research has been conducted concerning Bevacizumab?
"Currently, Bevacizumab has 643 distinct clinical trials in operation, with 143 at the final stage of development. Most are located in Taibei, Taiwan however a total of 32114 medical centres around the world have conducted research into this drug."
What medical conditions are commonly addressed through Bevacizumab?
"Commonly used to combat recurrent platinum-resistant epithelial ovarian cancer, bevacizumab may also provide relief for malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer, and unresectable melanoma."
Can you tell me the capacity of participants in this clinical study?
"Affirmative. Clinicaltrials.gov's records indicate that the trial, which was launched on June 15th 2017, is actively recruiting patients. There are 60 slots available at a single medical centre."
Has the FDA given their stamp of approval to Bevacizumab?
"Taking into account the Phase 2 status of bevacizumab, safety data is rated a score of 2. This indicates that while some corroborating evidence exists in regards to its security profile, there is presently no proof-of-concept demonstrating efficacy."
Is the research project currently taking on new participants?
"Affirmative. According to clinicaltrials.gov, this research is actively recruiting participants since its launch on June 15th 2017 and subsequent update on August 25th 2022. Sixty individuals are being sought out at a single location for the trial."
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