A Two-arm, Single Center Phase 1b Trial of Bavituximab Plus Ipilimumab in Advanced Melanoma Patients

Conditions

Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV — DRUG
Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV over 90 minutes every 3 weeks x 4. Total number of treated patients will be 16.
Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. — DRUG
Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. Total number of treated patients will be 8.

This is a Open label, two-arm, randomized, two agent, single center trial.

Active Comparator: A- Bavituximab plus Ipilimumab
Arm A-Interventions Drug: Bavituximab Dose:3mg/kg IV over 90 minutes weekly x 2 followed by Bavituximab 3mg/kg IV over 90 minutes weekly Duration-x 12 weeks plus Drug :Ipilimumab 3mg/kg IV over 90 minutes every 3 weeks Duration-x 4.weeks
Experimental: Arm B Ipilimumab
Arm B-Interventions Drug- I3mg/kg IV over 90 minutes day 1 followed three weeks later by Drug: Ipilimumab every 3 weeks x 3weeks. Total number of treated patients will be 8.

Toxicities [ Time Frame: 12 weeks ]

Facility	City	State	ZIP	Site coordinators
University of Texas Southwestern Medical Center	Dallas	Texas	75390-9179	-

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