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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02696356
Eligibility Criteria:
Inclusion Criteria:
* Males and females ≥18 years of age (at the time consent is obtained);
* Provide written informed consent for study participation, approved by the appropriate institutional review board (IRB), and be willing and able to cooperate with all aspects of the protocol;
* Resected, histologically proven, cutaneous melanoma determined to be Stage IIb, IIc, or III; according to the American Joint Commission of Cancer Staging, 7th edition
* Human leukocyte antigen (HLA)-A\*02+ by serology by an ASHI accredited laboratory;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0;
* Female subjects must have a negative serum human chorionic gonadotropic (hCG) test (pregnancy test not required for subjects with bilateral oophorectomy and/or hysterectomy or for those subjects who are \>1 year post-menopausal); and
* All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 3 months after the last dose of study drug.
Exclusion Criteria:
* Inadequate hematologic or biologic function as determined by the following laboratory tests:
* Hemoglobin \<10 g/dL,
* Platelet count \<100,000/µL,
* Leukocyte count \<3000/µL,
* Lymphocyte count \<1000/µL,
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>2 × upper limit of normal (ULN),
* Total bilirubin \>ULN: Subjects with Gilbert's syndrome are allowed if total bilirubin is \<3.0 mg/dL and direct bilirubin is ≤ULN,
* Serum creatinine \>ULN, or Prothrombin time (PT) or international normalized ratio (INR) \>1.5 × ULN or activated partial thromboplastin time (aPTT) \> 1.5 × ULN
* Greater than 3 months since melanoma resection;
* Have known fungal, bacterial, and/or viral infection, including human immunodeficiency virus (HIV) or hepatitis virus (B or C);
* Active immunosuppressive therapy associated with: Organ or allogeneic hematopoietic stem cell transplant, High-dose steroids, such as daily steroid doses in excess of 20 mg/day of prednisone (Note: Use of intra-articular or topical corticosteroids or eye drops containing corticosteroids is acceptable.), or Inhaled corticosteroids;
* Known history of autoimmune conditions including, but not limited to: rheumatoid arthritis, multiple sclerosis, lupus erythematosus, scleroderma, sarcoidosis, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis;
* Current requirement for anti-coagulation therapy that prolongs PT or aPTT 7. History of prior malignancy except: Curatively treated non-melanoma skin cancer; Solid tumor treated curatively \>5 years previously without evidence of recurrence; or History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect (e.g., superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast);
* Non-healed wound;
* Prior adjuvant therapy for current melanoma diagnosis;
* History of any clinically significant cardiovascular disorder (i.e., symptoms above Class II per New York Heart Association \[NYHA\] Functional Classification);
* History of serious allergic reaction to yeast or yeast-derived products, including known or suspected hypersensitivity reaction to sargramostim;
* Pregnant, breastfeeding, or planning to become pregnant during the study;
* Received any other investigational therapy within 28 days of Day 1; or
* Any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02696356
Study Brief:
Protocol Section:
NCT02696356