An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: IMC-20D7S (Cohort 1A); IMC-20D7S (Cohort 2A); IMC-20D7S (Cohort 3A); IMC-20D7S (Cohort 4A); IMC-20D7S (Cohort 1B); IMC-20D7S (Cohort 2B); IMC-20D7S (Cohort 3B)
Intervention description: 5 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A.; 10 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A.; 20 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A.; 30 mg/kg i.v. every 2 weeks.
Administered every other week on Days 1 and 15 of each treatment cycle.; 10 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B.; 20 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B.; 30 mg/kg i.v. every 3 weeks.
Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melanoma; Phase I; antibody; melanin; tyrosinase related protein 1; glycoprotein; 20D7S

Summary:

      A dose-escalation study designed to determine the safety, maximum tolerated dose (MTD),
      anti-melanoma activity, antibody blood levels and progression-free survival (PFS) in
      participants with malignant melanoma receiving IMC-20D7S either every 2 weeks or every 3
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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