a safety and efficacy study of intetumumab, alone and in combination with dacarbazine, in participants with stage 4 melanoma

Conditions: Melanoma

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.

this is a phase 1/2, multi-center, randomized (the study medication is assigned by chance) study. this study will be conducted in 2 phases (phase 1 and phase 2). phase 1 of this study will be non-randomized, open-label (all people know the identity of the intervention) and dose-escalation phase. it includes screening period and treatment period, which consists of 2 parts (part 1 and part 2). in part 1, participants will receive 1 of 3 single dose levels of intetumumab \[3 milligram per kilogram (mg/kg), 5 mg/kg or 10 mg/kg\]. part 2 will include 2 dose cohorts: dacarbazine plus intetumumab (5 mg/kg) or dacarbazine plus intetumumab (10 mg/kg). phase 2 of this study will be randomized, blinded (neither physician nor participant knows the intervention which the participant will receive) 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 will include 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, participants will be randomly assigned to 1 of 4 treatment groups, group 1: dacarbazine plus placebo, group 2: intetumumab (5 mg/kg), group 3: intetumumab (10 mg/kg) and group 4: dacarbazine plus intetumumab. randomization will be further based on the site of metastases and eastern cooperative oncology group performance status at baseline. single-medication intetumumab treatment groups will be open-label, while the dacarbazine plus intetumumab or placebo groups will be blinded. the total duration of the phase 2 of this study will be 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 participants that are responding to therapy with stable disease or better). participants will be assessed for incidence of dose limiting toxicities, pharmacokinetics and tumor responses. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * histologically confirmed melanoma including ocular and mucosal * documented ajcc (american joint committee on cancer) stage 3 unresectable or stage 4 melanoma (phase 1); ajcc stage 4 melanoma (phase 2) * radiographically measurable disease or measurable skin lesions * prior chemotherapy for metastatic melanoma will be allowed for phase 1, while previously untreated for melanoma by chemotherapy will be allowed for phase 2 * agrees to protocol-defined use of effective contraception exclusion criteria: * history of receiving murine or human/murine recombination products of human αν integrins * known human immunodeficiency virus (hiv) positivity and clinically important active infection * presence of bone metastases or malignant effusions (non-measurable lesions) and central nervous system metastases * prior radiation to target lesions * concurrent immunotherapy, biotherapy, radiotherapy, chemotherapy, or investigational therapy and therapeutic use of anticoagulation

Keywords: melanoma neoplasm cnto 95 dacarbazine intetumumab