Neoadjuvant Atezolizumab in Cutaneous Melanoma

NCT04020809 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: ML41440
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 coming back after surgery (high-risk).

Conditions

Cutaneous Melanoma

Keywords

atezolizumab; neoadjuvant; cutaneous melanoma

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  63 months

Secondary Outcomes (3)

• Pathological response rate in primary tumor and sentinel lymph node(s)

  63 months

• Two-year recurrence-free survival (RFS) rate

  63 months

• Two-year overall survival (OS) rate

  63 months

Study Arms (1)

Atezolizumab

EXPERIMENTAL

Atezolizumab will be administered as 1200 mg intravenously on Day 1 every 3 weeks for 2 cycles.

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

Anti-PD-L1 monoclonal antibody

Also known as: Tecentriq

Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nestor Esnaola, M.D.

  Houston Methodist Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: September 25, 2020
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)