Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant has histologically or cytologically confirmed cutaneous, mucosal, or uveal malignant melanoma which has progressed after or during at least 1 treatment with standard cytotoxic treatment or/and immunotherapy \[for example (e.g.), treatment with cytokines, monoclonal antibodies, and vaccines\] and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma
Participant is ≥18 years of age
Participant has either measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or evaluable disease
At least 21 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy. Relative to participant's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
Participant has resolution of all clinically significant toxic effects of prior cancer therapy to Grade ≤1 according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.02 (NCI-CTCAE v4.02)
Participant has adequate hematological function, hepatic function, and renal function
You may not be if
Participant has undergone major surgery \[e.g., laparotomy, thoracotomy, removal of organ(s)\] within 21 days prior to study entry
Participant has elective or planned surgery to be conducted during the trial
Participant has documented and/or symptomatic brain or leptomeningeal metastases
Participant is receiving systemic steroids or other immunosuppressive medications. (Intermittent use of steroid-containing medications e.g., for asthma exacerbation or for skin lesions is permitted)
Participant has an uncontrolled undercurrent illness
Participant has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm
Participant has a known allergy to any of the treatment components (monoclonal antibodies or other therapeutic proteins such as fresh frozen plasma, human serum albumin, cytokines, or interleukins). In the event that there is suspicion the participant may have allergies, the participant should be excluded
Participant is pregnant or lactating
Participant has known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) infection
