At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed melanoma (ocular, mucosal, or cutaneous)
- ✓AJCC Stage 3 unresectable or Stage 4 melanoma (Phase 1) or Stage 4 melanoma (Phase 2)
- ✓Radiographically measurable disease or measurable skin lesions
- ✓Phase 1: prior chemotherapy for metastatic melanoma allowed; Phase 2: chemotherapy-naive
- ✕Prior exposure to murine or human/murine recombinant products targeting human αv integrins
- ✕HIV-positive with clinically important active infection
- ✕Bone metastases, malignant effusions, or central nervous system metastases
- ✕Prior radiation to target lesions
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Intetumumab, Dacarbazine, and 1 other intervention for Melanoma. Completed, enrolled 144 participants across 32 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and effectiveness of the intetumumab, alone and in combination with dacarbazine, in patients with stage 4 melanoma.
Study Details
Timeline
Interventions
Intetumumab will be administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). In Phase 2, intetumumab (5 mg/kg or 10 mg/kg) will be administered for 8 cycles until no evidence of disease progression or unacceptable toxicity. If a participant responds to therapy with stable disease (SD) or better, the participant will be eligible to receive up to 8 cycles of extended administrations.
Commercially available dacarbazine will be administered intravenously over a 60-minute period (+30 minutes/-30 minutes) and prior to the intetumumab/placebo infusion. In case participants are unable to tolerate dacarbazine even after 2 dose reductions, they will be given the option to continue on intetumumab alone.
Placebo will be administered intravenously over a period of 2 hours (+15 minutes/-15 minutes).