Cutaneous MelanomaPhase 1NCT04020809
Neoadjuvant Atezolizumab in Cutaneous Melanoma
A Phase 1 study testing Atezolizumab in people with Cutaneous Melanoma, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this research study is to see whether using atezolizumab before surgery is safe and does not cause side effects that delay surgery in participants with cutaneous melanoma that has not spread to other areas of the body (non-metastatic) and can be removed by surgery (resectable) but has a higher risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma
- What is being tested?
- Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2020to 1 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form.
- Female or male.
- Age ≥18 years at time of signing informed consent form.
- Ability to comply with the trial protocol, in the investigator's judgment.
- Histologically confirmed cutaneous melanoma with pathological evidence of residual disease in place.
- Clinically non-metastatic (stage I-II) disease.
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- Technically resectable disease (no significant vascular, neural, or bony involvement and potential to safely achieve R0 resection) per the treating surgical oncologist.
- High-risk disease (clinical stage IA-IIC disease meeting criteria for sentinel lymph node biopsy as per the National Comprehensive Cancer Network guidelines [clinical stage IB-IIC (i.e., T1b-T4bN0M0) OR clinical stage IA (T1aN0M0) with high risk denoted by T1a with greater than or equal to 2 mitoses per mm2 OR lymphovascular invasion OR their combination]).
- Treatment-naïve.
- Eastern Cooperative Oncology Group performance status of 0-2.
- Adequate hematologic and end-organ function.
- Negative human immunodeficiency virus (HIV) test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥200/µL, and have an undetectable viral load.
- Negative hepatitis B surface antigen test at screening.
- Willing to provide biopsy and blood specimens as required by the trial.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year during the treatment period and for 5 months after the final dose of trial treatment. Women must also refrain from donating eggs during this same period.
Who cannot join
- Anal melanoma, vaginal melanoma, mucosal melanoma, or melanoma of soft parts.
- History of leptomeningeal disease.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
- Uncontrolled or symptomatic hypercalcemia.
- 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.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis scan.
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- Active tuberculosis.
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of trial treatment, unstable arrhythmia, or unstable angina.
- Major surgical procedure within 4 weeks prior to initiation of trial treatment.
- Severe infection within 4 weeks prior to initiation of trial treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of trial treatment.
- Prior allogeneic stem cell or solid organ transplantation.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of trial treatment, or anticipation of need for such a vaccine during trial treatment or within 5 months after the final dose of trial treatment.
- Current treatment with anti-viral therapy for hepatitis B virus.
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated antigen-4, anti-programmed cell death-1, and anti-PD-L1 therapeutic antibodies.
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2 within 4 weeks or 5 half-lives of the drug [whichever is longer]) prior to initiation of trial treatment
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha agents) within 2 weeks prior to initiation of trial treatment, or anticipation of need for systemic immunosuppressive medication during trial treatment.
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
- Current use of anticoagulants at therapeutic levels.
- Prior active malignancy within the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in place that have undergone potentially curative therapy.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.
- Pregnancy or breastfeeding, or intention of becoming pregnant during trial treatment or within 5 months after the final dose of trial treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Atezolizumab in Patients With Non-Metastatic Resectable High-Risk Cutaneous Melanoma
The purpose of this research study is to see whether using atezolizumab before surgery is safe and does not cause side effects that delay surgery in participants with cutaneous melanoma that has not spread to other areas of the body (non-metastatic) and can be removed by surgery (resectable) but has a higher risk of coming back after surgery (high-risk).
Read the detailed description
The purpose of this study is to test the safety of using atezolizumab before surgery in participants with cutaneous melanoma that has not spread to other areas of the body (non-metastatic) and can be removed by surgery (resectable) but has a higher risk of coming back after surgery (high-risk). Cutaneous melanoma in its earliest stages before it has spread to other areas of the body can usually be cured with surgery alone. Unfortunately, some cutaneous melanomas have a greater likelihood of coming back after surgery. Your immune system is normally your body's first defense against threats like cancer. But sometimes cancer cells produce signals that allow them to hide from attack by the immune system. One such signal is called programmed cell death-ligand 1 (PD-L1). Atezolizumab is a drug that blocks PD-L1. By blocking PD-L1, atezolizumab may boost your immune system to keep your cutaneous melanoma from coming back after surgery.
- Conditions
- Cutaneous Melanoma
- Being tested
- Atezolizumab
- Keywords
- atezolizumab, neoadjuvant, cutaneous melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called Tecentriq
Anti-PD-L1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab | Experimental | Atezolizumab will be administered as 1200 mg intravenously on Day 1 every 3 weeks for 2 cycles. Receives: Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants completing neoadjuvant atezolizumab
Determine the number of participants who complete the 2 neoadjuvant doses of atezolizumab without any extended treatment-related delay (defined as >80 days from Cycle 1 to date of surgical resection)
Measured: 63 months
Number of participants with treatment-related adverse events
Determine the number of participants with treatment-related adverse events, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Measured: 63 months
Secondary outcomes (3)
Pathological response rate in primary tumor and sentinel lymph node(s)
Determine the pathological response rate in primary tumor and sentinel lymph node(s) of neoadjuvant atezolizumab
Measured: 63 months
Two-year recurrence-free survival (RFS) rate
Determine the 2-year RFS rate of neoadjuvant atezolizumab
Measured: 63 months
Two-year overall survival (OS) rate
Determine the 2-year OS rate of neoadjuvant atezolizumab
Measured: 63 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start25 Sep 2020
- Primary completion1 Oct 2025
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Nestor Esnaola, The Methodist Hospital Research Institute
- Investigators
- Nestor Esnaola, M.D., Principal investigator, Houston Methodist Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020809
- Sponsor's protocol ID
- ML41440
- Status last verified
- Oct 2025
- First submitted
- 12 Jul 2019
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Atezolizumab in Patients With Non-Metastatic Resectable High-Risk Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT04020809
- Acronym / sponsor ID
- ML41440
- Conditions
- Cutaneous Melanoma
- Keywords
- atezolizumab, neoadjuvant, cutaneous melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see whether using atezolizumab before surgery is safe and does not cause side effects that delay surgery in participants with cutaneous melanoma that has not spread to other areas of the body (non-metastatic) and can be removed by surgery (resectable) but has a higher risk of coming back after surgery (high-risk).
Detailed description
The purpose of this study is to test the safety of using atezolizumab before surgery in participants with cutaneous melanoma that has not spread to other areas of the body (non-metastatic) and can be removed by surgery (resectable) but has a higher risk of coming back after surgery (high-risk). Cutaneous melanoma in its earliest stages before it has spread to other areas of the body can usually be cured with surgery alone. Unfortunately, some cutaneous melanomas have a greater likelihood of coming back after surgery. Your immune system is normally your body's first defense against threats like cancer. But sometimes cancer cells produce signals that allow them to hide from attack by the immune system. One such signal is called programmed cell death-ligand 1 (PD-L1). Atezolizumab is a drug that blocks PD-L1. By blocking PD-L1, atezolizumab may boost your immune system to keep your cutaneous melanoma from coming back after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab | Experimental | Drug: AtezolizumabAtezolizumab will be administered as 1200 mg intravenously on Day 1 every 3 weeks for 2 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed informed consent form.
- Female or male.
- Age ≥18 years at time of signing informed consent form.
- Ability to comply with the trial protocol, in the investigator's judgment.
- Histologically confirmed cutaneous melanoma with pathological evidence of residual disease in place.
Key exclusion criteria (24 listed)
- Anal melanoma, vaginal melanoma, mucosal melanoma, or melanoma of soft parts.
- History of leptomeningeal disease.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
- Uncontrolled or symptomatic hypercalcemia.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: TecentriqAnti-PD-L1 monoclonal antibody | Drug | Atezolizumab |
Primary outcome
Number of participants completing neoadjuvant atezolizumab
Time frame: 63 months
Determine the number of participants who complete the 2 neoadjuvant doses of atezolizumab without any extended treatment-related delay (defined as >80 days from Cycle 1 to date of surgical resection)
Number of participants with treatment-related adverse events
Time frame: 63 months
Determine the number of participants with treatment-related adverse events, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
3 secondary outcomes
Pathological response rate in primary tumor and sentinel lymph node(s)
Time frame: 63 months
Two-year recurrence-free survival (RFS) rate
Time frame: 63 months
Two-year overall survival (OS) rate
Time frame: 63 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nestor Esnaola, M.D. principal investigator
Houston Methodist Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atezolizumab in people with Cutaneous Melanoma, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants completing neoadjuvant atezolizumab (time frame: 63 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.