A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination with Ipilimumab in Patients with B7-H3-Expressing Melanoma, Squamous Cell Cancer of the Head and Neck or Non Small Cell Lung Cancer
The purpose of this study is to test the safety, tolerability, and most effective dose of MGA271 in combination with ipilimumab (also called Yervoy®). MGA271 has not been approved by any Authority that regulates new medicines, including the US Food and Drug Administration (FDA). Ipilimumab is approved by the FDA for use in melanoma patients, but it is experimental for NSCLC and SCCHN patients. This is the first time that MGA271 and ipilimumab will be given in combination. At the beginning of the study, 3-9 patients will be treated with a low dose of MGA271 and ipilimumab. If this dose does not cause bad side effects, it will slowly be made higher as new patients take part in the study (Dose Escalation Phase). Once the Dose Escalation Phase is complete, a Cohort Expansion Phase of the study will be conducted at the highest safe doses of MGA271 and ipilimumab.
Are you Eligible? (Inclusion Criteria)
Participants must be 18 years of age or older and have Melanoma that has progressed within 90 days prior to initiation of study drug or SCCHN or NSCLC that has progressed during or following 1 or more treatments.