An Open-Label, Dose-Escalation Study of IMC-20D7S In Patients With Malignant Melanoma

Inclusion Criteria:

• Patient 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 (eg, treatment with cytokines, monoclonal antibodies, and vaccines) and is not regarded to be a candidate for a potentially curative, higher priority treatment for melanoma
• Patient is ≥ 18 years of age
• Patient has either measurable disease as defined by RECIST 1.1 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 patient's treatment with non-approved biological products (eg, monoclonal antibodies), a minimum of 2 half-lives must have passed for eligibility to be considered
• Patient 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 (NCI-CTCAE) Version 4.02
• Patient has adequate hematological function, hepatic function, and renal function

Exclusion Criteria:

• Patient has undergone major surgery (eg, laparotomy, thoracotomy, removal of organ[s]) within 21 days prior to study entry
• Patient has elective or planned surgery to be conducted during the trial
• Patient has documented and/or symptomatic brain or leptomeningeal metastases
• Patient is receiving systemic steroids or other immunosuppressive medications.(Intermittent use of steroid-containing medications, eg, for asthma exacerbation or for skin lesions, is permitted)
• Patient has an uncontrolled undercurrent illness
• Patient has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm
• Patient 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 patient may have allergies, the patient should be excluded
• Patient is pregnant or lactating
• Patient has known HIV or AIDS infection