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PD-L1 Inhibitor
Atezolizumab + Bevacizumab for Melanoma
Phase 2
Recruiting
Research Sponsored by Elizabeth Buchbinder, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have normal organ and marrow function as defined below
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is researching whether or not a combination of two drugs that change the immune system and tumor could be a possible treatment for people with metastatic or unresectable stage III or IV cutaneous melanoma.
Who is the study for?
This trial is for adults with stage III or IV cutaneous melanoma that can't be removed by surgery. Participants must not have used certain cancer drugs before, agree to use effective contraception, and provide a tumor sample. They should have normal organ function and no history of severe allergies to the drugs being tested or other major health issues.Check my eligibility
What is being tested?
The study tests combining Atezolizumab (which helps the immune system fight cancer) with Bevacizumab (which stops tumors from making new blood vessels) as a treatment for advanced skin cancer. The goal is to see if this drug duo works better together.See study design
What are the potential side effects?
Possible side effects include high blood pressure, bleeding problems, allergic reactions similar to those caused by other antibodies or proteins in the drugs' family, infections due to weakened immune response, and potential heart or lung complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organ and bone marrow functions are normal.
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I am 18 years old or older.
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I agree to not have unprotected sex or donate sperm.
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My melanoma is at an advanced stage and cannot be removed with surgery.
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My cancer biopsy shows no PD-L1 protein.
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I can take care of myself but might not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate in PD-L1 negative melanoma
Secondary outcome measures
Change tumor-infiltrating lymphocytes (TILs)
Duration of response
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE 5.
+2 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Atezolizumab and BevacizumabExperimental Treatment2 Interventions
The research study procedures include screening for eligibility, study treatment including evaluations, a biopsy, and follow up visits.
Atezolizumab will be administered intravenously at a fixed predetermined dose every three weeks
Bevacizumab will be administered intravenously at a fixed predetermined dose every three weeks, with 21 consecutive days defined as a treatment cycle.
Treatment will be administered on an outpatient basis Study treatment will continue until study doctors decide to stop therapy due to criteria which may include disease progression, adverse events or changes in condition. Participants will be followed for survival health information following treatment until the study ends, which could be approximately 5 years from start of treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Bevacizumab
FDA approved
Find a Location
Who is running the clinical trial?
Elizabeth Buchbinder, MDLead Sponsor
Elizabeth BuchbinderLead Sponsor
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,869 Total Patients Enrolled
2 Trials studying Cutaneous Melanoma
45 Patients Enrolled for Cutaneous Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to similar drugs as atezolizumab or bevacizumab.My organ and bone marrow functions are normal.I have had treatments for skin cancer but not with anti-PD-L1 or bevacizumab.I am 18 years old or older.You must have a visible and measurable disease according to a specific set of guidelines.I have had leptomeningeal disease.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.I haven't taken any immune-weakening drugs in the last 2 weeks.I have not had a severe infection in the last 4 weeks.I have high calcium levels in my blood that are causing symptoms.You are allergic to Chinese hamster ovary cell products or any part of the atezolizumab medication.I haven't taken any immune-boosting drugs in the last 4 weeks or before their effects wore off.I have not had major surgery in the last 4 weeks.I have a serious wound, ulcer, or untreated bone fracture that is not healing.I have not had any abdominal inflammation in the last 6 months.I agree to not have unprotected sex or donate sperm.My high blood pressure is not well controlled.I haven't had any major abdominal issues like fistulas or abscesses in the last 6 months.I have previously been treated with bevacizumab or PD-L1 targeted therapy.You have had serious allergic reactions to certain types of medications in the past.I have or had an autoimmune disease or immune deficiency.You have tested positive for HIV.I have had another type of cancer in the last 2 years.I haven't had major surgery in the last 4 weeks.I am currently taking or have recently taken aspirin or blood thinners.I have brain metastases that are untreated or getting worse.My melanoma is at an advanced stage and cannot be removed with surgery.I am allergic to ingredients in the bevacizumab medication.I agree to use highly effective birth control during and after treatment.There is unexplained air in your belly, not from a recent surgery or medical procedure.I have had a severe hypertension crisis or brain issues due to high blood pressure.I have no health issues that prevent me from taking new medications.My cancer pain is not managed with current treatments.I take NSAIDs every day for a chronic condition.You have a bleeding disorder or a serious blood clotting problem.I have an active hepatitis B infection.I have not coughed up blood in the last month.You currently have an active hepatitis C virus (HCV) infection.I can provide a sample of my tumor for research.I have active tuberculosis.I have had a previous transplant of stem cells or an organ.I have not received a live vaccine in the last 4 weeks.My cancer biopsy shows no PD-L1 protein.I have not taken any strong antibiotics in the last 2 weeks.I have a serious heart condition.I have not had major blood vessel problems in the last 6 months.I can take care of myself but might not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab and Bevacizumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Could you provide an assessment of the potential hazards associated with Atezolizumab?
"The safety of Atezolizumab has been assessed and given a rating of 2, as this is Phase 2 trial without any data to support its efficacy."
Answered by AI
What is the size of the sample group participating in this research?
"Affirmative. The information on clinicaltrials.gov verifies that the trial is actively seeking participants, having been initially posted on August 6th 2020 and recently revised September 17th 2022. They are searching for 30 individuals from 3 different medical locations."
Answered by AI
Are there any precedential experiments that have included Atezolizumab?
"Currently, 621 research trials are investigating the efficacy of Atezolizumab. Of these studies, 142 have progressed to Phase 3 and are being conducted in Taibei, Taiwan; additionally there exist 31776 sites across the globe that are running tests for this medication."
Answered by AI
Are there open vacancies for participants in this experiment?
"This clinical trial, which was first made available on August 6th 2020, is currently open for enrolment. Recent updates to the study were posted on September 17th 2022."
Answered by AI
In what medical cases is Atezolizumab conventionally employed?
"Atezolizumab is principally employed to treat non-small cell lung carcinoma, though it has proven useful in the management of postoperative recurrent non-squamous non-small cell lung cancer and recurrence of platinum sensitive epithelial ovarian tumors."
Answered by AI
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