Trial Information

A Phase 1/2, Multi-Center, Blinded, Randomized, Controlled Study of the Safety and Efficacy of the Human Monoclonal Antibody to Human α ν Integrins (CNTO 95), Alone and in Combination With Dacarbazine, in Subjects With Stage IV Melanoma

This is a Phase 1/2, multi-center, randomized (the study medication is assigned by chance)
study. This study is conducted in 2 Phases (Phase 1 and Phase 2). Phase 1 of this study is
nonrandomized, open-label (all people know the identity of the intervention),
dose-escalation phase. It includes screening period and treatment period, which consists of
2 parts (Part 1 and Part 2). In Part 1, patients will receive 1 of 3 single dose levels of
CNTO 95 [3 mg/kg, 5 mg/kg, or 10 mg/kg]. Part 2 will include 2 dose cohorts, Cohort 1:
dacarbazine (DTIC) plus CNTO 95 [5 mg/kg] and Cohort 2: DTIC plus CNTO 95 [10 mg/kg]. Phase
2 of this study is randomized, blinded (neither physician nor patient knows the intervention
which the patient will receive nor any 1 of them does not know the intervention), and
controlled (an inactive substance and other medication is compared with a study medication
to test whether the medication has a real effect in this clinical study). This phase of the
study includes screening period, treatment period (8 cycles of treatment with every cycle
once in 3 weeks), and follow-up period (24 weeks). During the treatment period, patients
will be randomly assigned to 1 of 4 treatment groups, Group 1: DTIC plus placebo, Group 2:
CNTO 95 (5 mg/kg), Group 3: CNTO 95 (10 mg/kg), and Group 4: DTIC plus CNTO 95.
Randomization will be further based on the site of metastases at baseline and baseline
Eastern Cooperative Oncology Group performance status. Single-medication CNTO 95 treatment
groups will be open-label, while the DTIC plus CNTO 95 or placebo groups will be blinded.
The total duration of the Phase 2 of this study is up to 52 weeks or up to 76 weeks in case
of extended dosing (extended administrations [up to 8 additional cycles] of the same
assigned treatment will be allowed for patients that are responding to therapy with stable
disease or better). Safety evaluations will include adverse events, infusion reactions,
clinical laboratory tests, electrocardiogram, vital signs, and physical examination.