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Monoclonal Antibodies
Bevacizumab + Chemoimmunotherapy + Atezolizumab for Small Cell Lung Cancer with Liver Metastases(BELIEVE Trial)
Phase 2
Waitlist Available
Led By Kamya Sankar, MD
Research Sponsored by Kamya Sankar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group staging system), and radiographic confirmation of LM at diagnosis.
Presence of measurable disease outside the CNS per RECIST v1.1.
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom time of first dose until death from any cause, assessed up to approximately 48 months
Awards & highlights
No Placebo-Only Group
BELIEVE Trial Summary
This trial aims to find out if adding bevacizumab to atezolizumab and chemotherapy can help patients with ES-SCLC and liver metastases live longer without cancer progression.
Eligible Conditions
- Small Cell Lung Cancer
- Liver Metastases
BELIEVE Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with small cell lung cancer that has spread to your brain, confirmed by medical tests.
Select...
You have visible signs of disease in your body that can be measured according to a specific standard.
Select...
You have never had bleeding in your brain or spinal cord.
Select...
You previously had a specific type of lung cancer with a certain gene mutation, and it has now transformed into a different type that has spread to your liver. You have not received chemotherapy or immunotherapy for this type of cancer before.
Select...
You have a medical condition that can be measured using a standard criteria called RECIST v1.1.
Select...
The cancer has only spread to the brain in certain areas, but not to the brain stem or other critical parts of the brain.
BELIEVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of first dose until death from any cause, assessed up to approximately 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first dose until death from any cause, assessed up to approximately 48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6- month Progression Free Survival (PFS) rate
Secondary outcome measures
Incidence of adverse events
Objective Response Rate
Overall Survival (OS)
+1 moreOther outcome measures
Tissue and blood based biomarkers
Side effects data
From 2015 Phase 4 trial • 45 Patients • NCT0203642422%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
BELIEVE Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental TreatmentExperimental Treatment1 Intervention
Induction (ABCE): Atezolizumab 1200 mg, Bevacizumab 15 mg/kg, Carboplatin AUC5, Etoposide 100 mg/m2, given IV Q3weeks
Maintenance (AB): Atezolizumab 1200 mg and Bevacizumab 15 mg/kg given IV Q3weeks for 1 year, or until disease progression, or unacceptable toxicity
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2014
Completed Phase 4
~5320
Find a Location
Who is running the clinical trial?
University of MichiganOTHER
1,744 Previous Clinical Trials
6,585,020 Total Patients Enrolled
Kamya SankarLead Sponsor
Genentech, Inc.Industry Sponsor
1,531 Previous Clinical Trials
566,728 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your high blood pressure is not well managed.You had a hole or opening in your stomach or throat in the past 6 months before starting the study.You have visible signs of disease in your body that can be measured according to a specific standard.You have not received any previous treatment for ES-SCLC. However, if you received treatment for limited-stage SCLC, it must have been with the intention of curing the cancer and you must have completed treatment at least six months prior to being diagnosed with ES-SCLC.You have taken medication that weakens your immune system in the last two weeks, or you may need to take such medication during the study.You are able to understand and sign the consent form, and you can follow the study requirements.You have been diagnosed with small cell lung cancer that has spread to your brain, confirmed by medical tests.You have never had bleeding in your brain or spinal cord.You did not receive radiation therapy to the brain or underwent brain surgery within a certain time period before starting the study treatment.You previously had a specific type of lung cancer with a certain gene mutation, and it has now transformed into a different type that has spread to your liver. You have not received chemotherapy or immunotherapy for this type of cancer before.You have a medical condition that can be measured using a standard criteria called RECIST v1.1.The cancer has only spread to the brain in certain areas, but not to the brain stem or other critical parts of the brain.You can take low doses of corticosteroids or anticonvulsants, but the dose should not change during the study.You are currently using or planning to use traditional herbal medicines.You have had a transplant of stem cells or a solid organ from another person in the past.You have a severe, unhealed wound, open sore, or a broken bone that hasn't been treated.You have any other medical condition, physical finding or lab result that might prevent you from safely taking the experimental drug or could make it difficult to interpret the results of the trial.You cannot receive live, weakened vaccines starting four weeks before beginning the study treatment, while receiving atezolizumab, and for five months after the last dose of atezolizumab.You have or had a condition that affects your immune system or autoimmune disease, where your immune system attacks your own body.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any positions open for patients in this study?
"No, this particular study is not presently looking for participants. The clinicaltrials.gov website indicates that the study was first posted on February 1st 2023 and last updated on October 18th 2022. There are 2377 other trials active recruiting patients at the moment though."
Answered by AI
Has the FDA sanctioned this experimental procedure?
"There is some data supporting the safety of this experimental treatment, but none yet for efficacy. We gave it a score of 2."
Answered by AI
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