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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01239134
Eligibility Criteria:
Inclusion Criteria (Parts B \& C):
* 18 years or older
* Histologically confirmed unresectable Stage III or Stage IV malignant melanoma, or other solid tumor malignancies
* Failed to respond to or relapsed following standard treatment, declined or was not eligible for standard treatment.
* Expected survival of at least 12 weeks.
* Eastern Cooperative Oncology Group performance status score of 0 or 1 is required.
* Evidence of adequate organ function by standard laboratory tests.
Exclusion Criteria (Parts B \& C):
* Evidence of progression of central nervous system (CNS) metastases or symptomatic CNS metastases within 35 days prior to dosing.
* Ocular melanoma which has not metastasized or presence of a non-solid tumor.
* A history of any major surgery within 4 weeks prior to dosing.
* Any history of antitumor therapy completed within 28 days prior to dosing.
* Subjects with active autoimmune disease or history of known or suspected autoimmune disease, with the exception of subjects with isolated vitiligo, resolved childhood asthma/atopy, psoriasis not requiring systemic treatment and controlled thyroid disorders.
* Clinically significant heart disease, defined as NYHA Class III or IV.
* Any significant systemic infection requiring IV antibiotics.
* Known to be human immunodeficiency virus (HIV) positive, have hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCAb) unless HCV RNA undetected/negative.
* Treatment with any other anti-human GITR monoclonal antibody (mAb) or immunomodulatory therapy 42 days prior to dosing (30 days for Interleukin-2 \& Interferon-α, 7 days for Topical Imiquimod).
* Adverse events from prior anti-cancer therapy that have not resolved to grade ≤1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy.
* Use of any investigational drugs within 30 days prior to dosing.
* Any condition that requires or is likely to require treatment with pharmacologic doses of systemic corticosteroids. Subjects are permitted to receive physiologic replacement of corticosteroid therapy (≤ 10 mg prednisone daily).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01239134
Study Brief:
Protocol Section:
NCT01239134