Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT03489369
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients, ≥ 18 years of age at the time of obtaining informed consent.
* Documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic; patients with documented lymphomas.
* Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or nonresectability of the tumor.
* Refractory to or intolerant of existing therapy(ies) known to provide clinical benefit.
* Measurable or non-measurable disease according to RECIST v1.1 or RECIL 2017.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 6 months after the last dose of study drug.
Exclusion Criteria:
* Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug. Women of childbearing potential (WOCBP) and fertile men with WOCBP partner(s), not using and not willing to use a highly effective method of contraception.
* Known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression, patients with any of the above not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
* Hematologic malignancies other than lymphomas.
* Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to Cycle 1/Day 1 (C1/D1) unless adequately treated and considered stable
* Active uncontrolled bleeding or a known bleeding diathesis
* Clinically significant cardiovascular disease or condition
* Significant pulmonary disease or condition
* Current or recent (within 6 months) significant gastrointestinal (GI) disease or condition.
* An active, known, or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome, requiring systemic steroids or other immunosuppressive medications.
* History of organ transplantation (e.g. stem cell or solid organ transplant)
* History of significant toxicities associated with previous administration of immune checkpoint inhibitors that necessitated permanent discontinuation of that therapy
* Patients with unresolved \> Grade 1 toxicity associated with any prior antineoplastic therapy, with exceptions.
* Inadequate recovery from any prior surgical procedure, or having undergone any major surgical procedure within 4 weeks prior to C1/D1.
* Known history of human immunodeficiency virus (HIV) or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Other Inhibitors of LAG-3
* Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest, prior to first administration of study drug and during study
* Any other investigational treatments within 4 weeks prior to and during study
* Radiotherapy for target lesions within 4 weeks prior to first administration of study drug unless PD has been documented in the lesion following treatment, and during study.
* Radiotherapy for non-target lesions within 1 week prior to first administration of study drug
* Immunosuppressive or systemic hormonal therapy
* Prophylactic use of hematopoietic growth factors within 1 week prior to first administration of study drug and during Cycle 1 of study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03489369
Study Brief:
Protocol Section:
NCT03489369