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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT02536469
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have metastatic or unresectable locally advanced malignant solid tumor.
* Patients may have measurable or non-measurable but evaluable disease.
* Patients with surgically resected metastatic disease at high risk of relapse are also eligible.
* Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease.
* Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy
* Age ≥ 18 years. .
* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1 (Karnofsky ≥ 70%).
* Patients must have normal organ and hematologic function therapy
* Patients must have baseline pulse oximetry \> 90% on room air
Exclusion Criteria:
* Pregnant women or women presently breast-feeding
* Concurrent treatment for cancer
* Chronic hepatitis B or C infection.
* Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
* Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
* Active autoimmune diseases requiring treatment or a history of autoimmune disease.
* Concurrent use of systemic steroids
* Patients who are receiving any other investigational agents
* Patients with untreated central nervous system metastases or local treatment of brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agent used in study.
* Serious or uncontrolled intercurrent illness
* HIV-positive patients are ineligible
* Patients unwilling to use adequate contraception
Other protocol defined inclusion/exclusion criteria could apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02536469
Study Brief:
Protocol Section:
NCT02536469