A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
A Feasibility Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 120 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 16 weeks, 2 years
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "They will have blood tests and imaging scans."
- "Researchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks."
- "Study treatment may last up to 2 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether lower doses of atezolizumab, a drug that helps the immune system fight cancer, can work as well with fewer side effects. Blood tests will help guide the time between doses. It is for adults with cancer that has spread nearby or to other organs who can receive this drug.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older with cancer confirmed by a tissue test. A cancer care provider must decide that atezolizumab is a treatment option.
- Have cancer that can be measured on scans. Be able to care for yourself and be out of bed or a chair for at least half the day.
- Have blood counts and liver and kidney test results that meet the study's limits.
- If you can become pregnant or father a child, follow the study's birth control rules through 5 months after the last dose. If breastfeeding, stop during treatment and for 5 months afterward.
- If you have HIV or hepatitis B or C, blood tests must not detect the virus. HIV must be treated, and hepatitis B must be treated if needed.
- If cancer has spread to your brain and was treated, follow-up scans must show it is not getting worse.
- Any other cancer must not interfere with checking this treatment's safety or effects.
- Be able and willing to understand and sign a consent form.
Who can't join
- Certain recent treatments: an unapproved study drug or immune checkpoint cancer drug within 28 days; medicines that boost or weaken the immune system, or herbal medicines, within 1 month; or a live vaccine within 4 weeks. Some steroid use is allowed. Any past CD137-boosting treatment also excludes you.
- A history or risk of autoimmune disease, where the immune system attacks the body. Some controlled thyroid disease, type 1 diabetes, and mild skin-only conditions are allowed under study rules.
- Lasting side effects from past treatment that are more than mild, unless the study team allows them. Hair loss and some nerve-related numbness or tingling are allowed.
- A past bone marrow transplant from another person or an organ transplant.
- Severe allergic reactions to certain antibody or protein drugs, or a known allergy to atezolizumab ingredients or products made using Chinese hamster ovary cells.
- Active tuberculosis, or certain past or current lung scarring or inflammation. Lung scarring from radiation in the treated area is allowed.
- Serious heart or blood vessel disease, including certain heart problems, a heart attack, or a stroke within the study's time limits.
- Pregnancy, or an uncontrolled illness or other situation that would prevent you from following study requirements.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
* INCLUSION CRITERIA: * 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. Individuals who can father children must agree to use an effective method of contraception (barrier, surgical sterilization) at study entry and up to 5 months after the last dose of the atezolizumab. * 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 CRITERIA: Participants who have received an investigational agent for treating participants' disease not approved by FDA within 28 days prior to study treatment initiation. * 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.
Study sites (1)
MD
- National Institutes of Health Clinical Center · Bethesda, MD 20892National Cancer Institute Referral Office · Study contact · 888-624-1937More trials in Bethesda