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Neoadjuvant Atezolizumab for Melanoma

Phase 1
Waitlist Available
Led By Ashley Holder, M.D.
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed cutaneous melanoma with pathological evidence of residual disease in place
Treatment-naïve
Must not have
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
Prior allogeneic stem cell or solid organ transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 63 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether using atezolizumab before surgery is safe and does not cause side effects that would delay the surgery.

Who is the study for?
This trial is for adults with high-risk, non-metastatic cutaneous melanoma that can be surgically removed. Participants must have no prior treatments, good organ function, and a performance status of 0-2. They should not have had major surgery or live vaccines recently, nor should they have active infections or certain other health conditions.
What is being tested?
The study tests if atezolizumab given before surgery is safe and won't delay the procedure in patients with resectable cutaneous melanoma at high risk of recurrence post-surgery.
What are the potential side effects?
Atezolizumab may cause immune-related side effects such as inflammation in various organs, infusion reactions, fatigue, possible infection risks, and allergic reactions to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My skin cancer is confirmed and still present after initial treatment.
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I have not received any treatment for my condition.
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My cancer has not spread beyond its original site.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had an autoimmune disease or immune deficiency.
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I have had a previous transplant of stem cells or an organ.
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I have high calcium levels in my blood that are causing symptoms.
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I have active tuberculosis.
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I have not received a live vaccine in the last 4 weeks and do not plan to during or within 5 months after the trial.
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I haven't taken any immune-weakening drugs in the last 2 weeks.
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I have had cancer spread to the lining of my brain and spinal cord.
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I am currently on medication for hepatitis B.
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I am currently taking blood thinners at treatment doses.
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My melanoma is located in a specific area such as the anus, vagina, mucosa, or soft parts.
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I frequently need procedures to remove excess fluid from my body.
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I have a history of specific lung conditions not caused by known factors.
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I have previously been treated with specific immune therapies.
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I have not had a severe infection or been hospitalized for one in the last 4 weeks.
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I haven't had major heart problems or strokes in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~63 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 63 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants completing neoadjuvant atezolizumab
Number of participants with treatment-related adverse events
Secondary study objectives
Pathological response rate in primary tumor and sentinel lymph node(s)
Two-year overall survival (OS) rate
Two-year recurrence-free survival (RFS) rate

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
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%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AtezolizumabExperimental Treatment1 Intervention
Atezolizumab will be administered as 1200 mg intravenously on Day 1 every 3 weeks for 2 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
285 Previous Clinical Trials
81,666 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,559 Previous Clinical Trials
569,434 Total Patients Enrolled
Ashley Holder, M.D.Principal InvestigatorHouston Methodist Cancer Center

Media Library

Atezolizumab Clinical Trial Eligibility Overview. Trial Name: NCT04020809 — Phase 1
Skin Cancer Research Study Groups: Atezolizumab
Skin Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04020809 — Phase 1
Atezolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04020809 — Phase 1
~4 spots leftby Dec 2025
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