RECRUITING

Atezolizumab for Idiopathic Pulmonary Fibrosis

Conditions

Idiopathic Pulmonary Fibrosis pulmonary fibrosis ipf

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the safety and preliminary efficacy of atezolizumab, an immune checkpoint inhibitor approved for the treatment of various cancers, in patients with idiopathic pulmonary fibrosis (IPF).

Official Title

A Phase I Study to Evaluate the Safety and Preliminary Efficacy of Atezolizumab in Idiopathic Pulmonary Fibrosis

Quick Facts

Study Start:2023-02-15

Study Completion:2026-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05515627

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Males or females ≥50 years of age * Confident diagnosis of IPF per 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline on Diagnosis of IPF1 * Subjects must have a high-resolution computed tomography (HRCT) completed in the 6 months prior to informed consent * Subjects must have HRCT pattern of definite or probable UIP * Subjects without HRCT pattern of definite or probable UIP must have surgical lung biopsy showing histopathology consistent with UIP * Extent of fibrotic changes must be greater than the extent of emphysema on HRCT * Review of all available IPF treatment options with the potential subject prior to consent for participation in the study * Negative hepatitis B surface antigen (HBsAg) test at screening * Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAB test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test. * Negative hepatitis C antibody * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:	* FVC \<50% of predicted, DLCO \< 30% of predicted, FEV1/FVC ratio \<0.7 * Significant clinical worsening of IPF between screening and baseline visits as defined by \> 10% decline in FVC or new requirement for supplemental oxygen * Evidence of secondary etiologies of ILD (signs/symptoms of connective tissue disease, including ANA titer \> 1:80, history of exposures related to hypersensitivity pneumonitis, history of drug-related pulmonary toxicity, occupational exposures) * Evidence of comorbid pulmonary pathology including but not limited to asthma, tuberculosis, sarcoidosis, chronic infections * Any acute illness or febrile event that has not resolved at least 14 days prior to either screening or dosing * Use of tobacco-containing products within the last 3 months and/or unwillingness to abstain from use for the duration of the study * Participation in a clinical study involving administration of other investigational drugs in the 30 days prior to screening * Any condition that in the opinion of the investigators would confound the ability to interpret data from the study * QTc \> 470 msec * Any comorbid condition that is likely to result in death within the next year * Inability to obtain reproducible, high-quality pulmonary function tests * Likelihood of lung transplantation in the first 24 weeks of the study * Use of other IPF-directed therapies beside SOC including but not limited to endothelium receptor antagonists, interferon gamma-1b, N-acetylcysteine * Initiation of pirfenidone or nintedanib less than 90 days prior to screening * Current therapy or treatment within 60 days prior to screening of any cytotoxic or immunosuppressive medications, cytokine modulating therapies, and oral anticoagulants within 4 weeks of the screening visit. Note: oral anticoagulants taken for alternative diagnoses are acceptable and should not be discontinued for the sole purpose of study participation. * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies * Use of an inhaled long-acting bronchodilator within 24 hours of the Screening Visit or short-acting bronchodilator within 8 hours of the Screening Visit * History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months of the Screening Visit and/or recurrent DVT or recurrent PE * Active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including, but not limited to, atypical mycobacterial disease and herpes zoster), or any major episode of infection requiring hospitalization or treatment with intravenous or oral antibiotics within 4 weeks of the Screening Visit and at any time during the Screening Phase, up through the first dose of study drug * History of latent or active TB, unless there is medical record documentation of successful completion of a standard course of treatment for latent TB * Diagnosis of any clinically significant autoimmune disease, with the exclusion of vitiligo and diabetes mellitus. * Pregnancy or lactation * History of leptomeningeal disease * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Patients with indwelling catheters (e.g., PleurX) are allowed. * Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN) * 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 study treatment, unstable arrhythmia, or unstable angina * Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study * History of malignancy, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer * 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 study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab * Current treatment with anti-viral therapy for HBV * 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 * Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment. * Patients at increased risk of adverse outcomes given the known safety profile for atezolizumab and SOC medications (hepatitis, colitis, endocrinopathies, nephritis/renal dysfunction, exfoliative dermatitis)

Inclusion Criteria

Exclusion Criteria

* Males or females ≥50 years of age
* Confident diagnosis of IPF per 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline on Diagnosis of IPF1
* Subjects must have a high-resolution computed tomography (HRCT) completed in the 6 months prior to informed consent
* Subjects must have HRCT pattern of definite or probable UIP
* Subjects without HRCT pattern of definite or probable UIP must have surgical lung biopsy showing histopathology consistent with UIP
* Extent of fibrotic changes must be greater than the extent of emphysema on HRCT
* Review of all available IPF treatment options with the potential subject prior to consent for participation in the study
* Negative hepatitis B surface antigen (HBsAg) test at screening
* Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAB test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
* Negative hepatitis C antibody
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:

* FVC \<50% of predicted, DLCO \< 30% of predicted, FEV1/FVC ratio \<0.7
* Significant clinical worsening of IPF between screening and baseline visits as defined by \> 10% decline in FVC or new requirement for supplemental oxygen
* Evidence of secondary etiologies of ILD (signs/symptoms of connective tissue disease, including ANA titer \> 1:80, history of exposures related to hypersensitivity pneumonitis, history of drug-related pulmonary toxicity, occupational exposures)
* Evidence of comorbid pulmonary pathology including but not limited to asthma, tuberculosis, sarcoidosis, chronic infections
* Any acute illness or febrile event that has not resolved at least 14 days prior to either screening or dosing
* Use of tobacco-containing products within the last 3 months and/or unwillingness to abstain from use for the duration of the study
* Participation in a clinical study involving administration of other investigational drugs in the 30 days prior to screening
* Any condition that in the opinion of the investigators would confound the ability to interpret data from the study
* QTc \> 470 msec
* Any comorbid condition that is likely to result in death within the next year
* Inability to obtain reproducible, high-quality pulmonary function tests
* Likelihood of lung transplantation in the first 24 weeks of the study
* Use of other IPF-directed therapies beside SOC including but not limited to endothelium receptor antagonists, interferon gamma-1b, N-acetylcysteine
* Initiation of pirfenidone or nintedanib less than 90 days prior to screening
* Current therapy or treatment within 60 days prior to screening of any cytotoxic or immunosuppressive medications, cytokine modulating therapies, and oral anticoagulants within 4 weeks of the screening visit. Note: oral anticoagulants taken for alternative diagnoses are acceptable and should not be discontinued for the sole purpose of study participation.
* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
* Use of an inhaled long-acting bronchodilator within 24 hours of the Screening Visit or short-acting bronchodilator within 8 hours of the Screening Visit
* History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 6 months of the Screening Visit and/or recurrent DVT or recurrent PE
* Active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including, but not limited to, atypical mycobacterial disease and herpes zoster), or any major episode of infection requiring hospitalization or treatment with intravenous or oral antibiotics within 4 weeks of the Screening Visit and at any time during the Screening Phase, up through the first dose of study drug
* History of latent or active TB, unless there is medical record documentation of successful completion of a standard course of treatment for latent TB
* Diagnosis of any clinically significant autoimmune disease, with the exclusion of vitiligo and diabetes mellitus.
* Pregnancy or lactation
* History of leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Patients with indwelling catheters (e.g., PleurX) are allowed.
* Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN)
* 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 study treatment, unstable arrhythmia, or unstable angina
* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* History of malignancy, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
* 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 study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
* Current treatment with anti-viral therapy for HBV
* 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
* Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
* Patients at increased risk of adverse outcomes given the known safety profile for atezolizumab and SOC medications (hepatitis, colitis, endocrinopathies, nephritis/renal dysfunction, exfoliative dermatitis)

Contacts and Locations

Study Contact

Study Coordinator

CONTACT

310-423-8474

GroupLungResearch@cshs.org

Vivian Hwe

CONTACT

vivian.hwe@cshs.org

Principal Investigator

Tanzira Zaman, MD

PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

Tanzira Zaman, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-15

Study Completion Date2026-04-30

Study Record Updates

Study Start Date2023-02-15

Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

pulmonary fibrosis
ipf
idiopathic pulmonary fibrosis

Additional Relevant MeSH Terms

Idiopathic Pulmonary Fibrosis