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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT03589651
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or participants who are intolerant to or have declined standard therapy
* Measurable or nonmeasurable tumor lesions per RECIST v 1.1.
* Willing to provide fresh or archival tumor tissue for correlative studies.
* Eastern Cooperative Oncology Group performance status 0 to 1.
* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.
Exclusion Criteria:
* Receipt of anticancer therapy within 21 days of the first administration of study treatment, with the exception of localized radiotherapy.
* Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of alopecia and anemia not requiring transfusional support).
* Laboratory values outside the protocol-defined range at screening.
* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.
* Known hypersensitivity to any of the study drugs, excipients, or another monoclonal antibody which cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
* Evidence of interstitial lung disease or active, noninfectious pneumonitis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03589651
Study Brief:
Protocol Section:
NCT03589651