Atezolizumab Dosing Study for Advanced Cancers
This study is looking at different ways to give atezolizumab, a drug that helps your immune system fight cancer. Researchers want to see if lower doses of atezolizumab, given at different times, can work just as well as current doses while potentially causing fewer side effects. You might be able to join if you are 18 or older and have certain advanced cancers, such as alveolar soft part sarcoma or non-small cell lung cancer, and your doctor thinks atezolizumab is a good treatment option for you. The main goal is to see if we can reduce the amount of drug given while keeping the right level of medicine in your blood for at least 16 weeks.
- Study design
- This is an interventional study with a planned enrollment of 30 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will be screened, have blood tests, and undergo imaging scans. The study involves receiving atezolizumab through an IV at different doses and schedules.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures drug concentration at 16 weeks, suggesting follow-up for at least this duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06066138
A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~30 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Atezolizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of reducing drug exposure while maintaining plasma drug concentration
Measured over 16 weeks
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- James L Gulley, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants with a locally advanced or metastatic pathologically confirmed cancer whose NCI Licensed Independent Practitioner (LIP) determined they are candidates for treatment with atezolizumab, either alone or in combination with other FDA-approved drug(s), for example, TMB-high, PDL-1 positive, or other disease states that respond to PD(L)-1 inhibitors. Regimens with atezolizumab alone or in combination with agents that have previously demonstrated safety in published clinical trials may be used. An LIP may be either an MD, DO, PA, or NP and must be qualified for oncologic management per institutional practice.
Age \>=18 years old.
Measurable disease per RECIST 1.1 criteria.
ECOG performance status of 0-2.
Participants must have adequate organ and marrow function as defined below:
Absolute neutrophil count (ANC) \>=1,200/microliter
Hemoglobin \>9.0 g/dL
Platelets \>=75,000/microliter
Total bilirubin \<= 1.5 mg/dL, except in participants with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg/dL
Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \<=2.5 X institutional upper limit of normal (ULN)
Creatinine Clearance (CrCl) \>=30 mL/min/1.73 m\^2 (calculated using the Cockcroft-Gault formula).
Serum albumin \> 3 g/dL
Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 5 months after the last dose of the atezolizumab (restriction period). NOTE: abstinence, defined as no vaginal heterosexual intercourse within 6 months prior to the treatment initiation and willingness to continue abstinence for restriction period is also acceptable.
Nursing participants must be willing to discontinue nursing from study treatment initiation through 5 months after atezolizumab treatment discontinuation.
Participants with history of human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and have undetectable viral load.
Participants with history of chronic hepatitis B virus (HBV) infection must be on suppressive therapy, if indicated, and have undetectable HBV viral load.
Participants with history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load.
Participants with history of treated brain metastases must have follow-up brain imaging after central nervous system (CNS)-directed therapy with no evidence of progression.
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible.
All participants must have the ability to understand and willingness to sign a written informed consent.
Exclusion
Participants who have received immunostimulatory agents, including, but not limited to, IFN-alpha, IFN-gamma, or IL-2, immunosuppressive medications, and any herbal medicines within 1 month prior to study treatment initiation. NOTE: Physiologic doses of systemic steroids (\<= 10 mg prednisone or equivalent) or local (e.g., topical, nasal, intraarticular, inhaled) steroid use is permitted.
Prior treatment with CD137 agonists
Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies; (including atezolizumab) within 28 days prior to study treatment initiation.
History or risk of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:
Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone.
Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen.
Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis would be excluded) are permitted provided all of the following conditions are met:
Rash must cover less than 10% of body surface area (BSA)
Disease is well controlled at screening and only requiring low potency topical steroids
No acute exacerbations of underlying condition within 12 months prior to study treatment initiation (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) within 12 months prior to study treatment initiation.
Persisting toxicity related to prior therapy of Grade \>1 per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 unless deemed not clinically significant or irreversible. NOTE: alopecia and sensory neuropathy Grade \<= 2 are acceptable.
Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
Active tuberculosis at screening
History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Participants with significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident (https://www.heart.org/en/health-topics/heart-failure/what-isheart-failure/classes-of-heart-failure), unstable arrhythmia, or unstable angina within 3 months prior to study treatment initiation.
Pregnancy (confirmed with Beta-Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in IOCBP performed at screening).
Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.
What this trial measures
- Feasibility of reducing drug exposure while maintaining plasma drug concentration16 weeks
The fraction of participants that can be dosed with 840mg of atezolizumab at less frequent intervals while maintaining a trough PK concentration at or above 6 mg/mL