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:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT02561234
Eligibility Criteria:
Inclusion Criteria:
For patients participating in any part of the trial:
* has an advanced solid tumor previously treated with, or inability to tolerate, standard therapy for the disease, or for which a standard therapy does not exist, and as such is considered a candidate for Phase 1 treatment
* has adequate organ function: Hgb ≥9 g/dL; absolute neutrophil count (ANC) ≥ 1.5x109/L; plt ≥ 100,000/μL; AST and ALT \< 2.5x ULN (\< 5x ULN in patients with liver metastases); total bilirubin \< 2.0 mg/dL; serum creatinine ≤ 1.5x ULN
* ECOG performance score 0-2
For patients participating in any expansion group:
* has measurable disease based on RECIST 1.1 as determined by the treating investigator. Tumor lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
* willing to consent for biopsy is strongly recommended but not mandatory
* recovery of toxicities related to any prior treatments to at least Grade 1 by CTCAE v 4.03. Exceptions are patients with adverse event(s) that are clinically nonsignificant and/or stable on supportive therapy.
For patients participating in specific expansion groups:
Cutaneous Melanoma:
* unresectable, locally advanced or metastatic (AJCC stage IIIB, IIIC, or IV) cutaneous malignant melanoma
* relapsed or progressive disease after or unable to tolerate at least one prior systemic anticancer regimen for metastatic disease involving immunotherapy (anti-PD-1, anti-PD-L1, or anti-CTLA-4)
* in tumors with a relevant BRAF mutation, relapsed, refactory, or unable to tolerate at least one prior systemic anticancer regimen for metastic disease involving a BRAF inhibitor
Uveal Melanoma:
* uveal melanoma at metastic stage
Small Cell Lung Cancer:
* extensive disease previously treated with, or inability to tolerate, platinum-based chemotherapy
Exclusion Criteria:
* has primary CNS malignancy
* history of untreated brain mets or leptomeningeal disease or spinal cord compression
* effects of prior anticancer therapy recovered to grade \< 2
* known HIV
* active infection
* major surgery within 2 weeks
* history of another malignancy within 2 years prior
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02561234
Study Brief:
Protocol Section:
NCT02561234