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Monoclonal Antibodies

Bevacizumab + Atezolizumab +/- Cobimetinib for Melanoma Brain Metastases

Phase 2
Waitlist Available
Led By Hussein A Tawbi
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Asymptomatic off steroids for at least 10 days except patients with mild symptoms from intracranial disease that do not affect their performance status or who are asymptomatic but require steroids for control of symptoms on a maximum dose of dexamethasone 4mg/day orally (PO) or equivalent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with untreated melanoma that has spread to the brain. Participants must be willing to use contraception, have an ECOG performance status of 0-2, and a life expectancy over 12 weeks. They should not have had certain prior treatments or suffer from conditions like autoimmune diseases, severe infections, or significant heart problems.Check my eligibility
What is being tested?
The study is testing how well the combination of monoclonal antibodies (bevacizumab and atezolizumab) works with or without cobimetinib in treating melanoma brain metastases. It aims to see if adding cobimetinib improves treatment outcomes.See study design
What are the potential side effects?
Possible side effects include high blood pressure and bleeding from bevacizumab; fatigue, nausea, and immune-related reactions from atezolizumab; and rash, liver enzyme elevation, and vision changes from cobimetinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I haven't needed steroids for 10 days, or I'm on a low dose for brain-related symptoms.
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I've had treatments for melanoma spread outside the brain but not with PD-1/PD-L1 inhibitors.
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I can provide tumor samples with a pathology report for PD-L1 testing.
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I am 18 years old or older.
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My melanoma does not have the BRAFV600 mutation.
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I have a brain tumor that can be measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective intracranial response rate (OIRR) as measured by the modified immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria
Safety, tolerability, and efficacy of atezolizumab, bevacizumab, and cobimetinib (Arm II)
Secondary outcome measures
Duration of response (DOR)
Incidence of adverse events graded according to CTCAE version 4.0 (Arm II)
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Arm I)
+3 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II (atezolizumab, bevacizumab, cobimetinib)Experimental Treatment4 Interventions
Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Cycles with atezolizumab and bevacizumab repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients also receive cobimetinib PO TID on days 1-21. Cycles with cobimetinib repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (atezolizumab, bevacizumab)Experimental Treatment3 Interventions
Participants receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~6040
Bevacizumab
2013
Completed Phase 4
~5280
Cobimetinib
2015
Completed Phase 3
~2630
Quality-of-Life Assessment
2017
Completed Phase 3
~4950

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,420 Total Patients Enrolled
102 Trials studying Melanoma
25,315 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,617 Total Patients Enrolled
557 Trials studying Melanoma
193,204 Patients Enrolled for Melanoma
Hussein A TawbiPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
454 Total Patients Enrolled
3 Trials studying Melanoma
154 Patients Enrolled for Melanoma

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03175432 — Phase 2
Melanoma Research Study Groups: Arm I (atezolizumab, bevacizumab), Arm II (atezolizumab, bevacizumab, cobimetinib)
Melanoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03175432 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03175432 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~1 spots leftby Jun 2024