Actively Recruiting
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
Led by National Cancer Institute (NCI) · Updated on 2026-04-20
30
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers. Researchers want to find out if lower doses of this drug might provide the same benefit with fewer adverse effects. Objective: To test different doses and timing of atezolizumab for people with cancer. Eligibility: People aged 18 years and older with cancer that has spread locally or to other organs. They must be eligible for treatment with the study drug. Design: Participants will be screened. They will have blood tests and imaging scans. They will provide a sample of tissue from their tumor. Atezolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will take this drug alone or combined with other drugs prescribed for their care. The first 2 treatments will be done per the FDA recommended dose and schedule. Before administering the second dose of the study drug, researchers will check the level of the drug in the participant s blood. Depending on those results, their 3rd dose will be scheduled 2 to 6 weeks later. For the 3rd dose of the study drug, participants will switch to the FDA minimum dosage. Dosages of any other drugs will not change. Researchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks. After that, these levels will be tested every 3 months. Study treatment may last up to 2 years.
CONDITIONS
Official Title
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with locally advanced or metastatic confirmed cancer eligible for atezolizumab treatment alone or with other FDA-approved drugs
- Age 18 years or older
- Measurable disease as per RECIST 1.1 criteria
- ECOG performance status of 0 to 2
- Adequate organ and marrow function including ANC \u22651,200/microliter, hemoglobin >9.0 g/dL, platelets \u226575,000/microliter, total bilirubin \u22641.5 mg/dL (or <3.0 mg/dL if Gilbert's Syndrome), AST/ALT \u22642.5 times institutional upper limit, creatinine clearance \u226530 mL/min/1.73 m\u00b2, serum albumin >3 g/dL
- Use of highly effective contraception or abstinence during treatment and for 5 months after last dose
- Effective contraception for individuals who can father children during study and for 5 months after last dose
- Willingness to discontinue nursing from treatment start through 5 months after treatment
- Participants with HIV on effective therapy with undetectable viral load
- Participants with chronic hepatitis B on suppressive therapy and undetectable viral load
- Participants with hepatitis C with undetectable viral load
- Participants with treated brain metastases with no progression on follow-up imaging
- Prior or concurrent malignancies not interfering with study safety or efficacy
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior investigational agent for disease within 28 days before starting study treatment
- Use of immunostimulatory or immunosuppressive medications or herbal medicines within 1 month before treatment (except low-dose steroids or local steroid use)
- Prior treatment with CD137 agonists
- Prior immune checkpoint blockade therapies including atezolizumab within 28 days before treatment
- History or risk of autoimmune diseases except controlled hypothyroidism, controlled type 1 diabetes, or certain mild dermatologic autoimmune conditions
- Persistent toxicity related to prior therapy greater than Grade 1 (except alopecia and mild neuropathy)
- Prior allogeneic bone marrow or solid organ transplantation
- Severe allergic reactions to antibodies or components of atezolizumab
- Treatment with live attenuated vaccine within 4 weeks before treatment
- Active tuberculosis
- History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or active pneumonitis on screening CT
- Significant cardiovascular disease within 3 months before treatment
- Pregnancy confirmed by test at screening
- Uncontrolled illnesses or conditions limiting study compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI Medical Oncology Referral Office
CONTACT
J
James L Gulley, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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