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

Melanoma Clinical Trial

Official title: A Two-Arm, Single Center Pase 1b Trial of Bavituximab Plus Ipilimumab in Advanced Melanoma Patients

Status Terminated

Clinical Trial Summary

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

Clinical Trial Description

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

Study Product(s), Dose, Route, Regimen:

Bavituximab 3mg/kg IVqwk (IV every week) x 14 plus ipilimumab 3mg/kg IVq3wk (IV every 3 weeks) x 4 or ipilimumab 3mg/kg IVq3wk x 4

Administration Schedule:

Patients will be randomized to one of the following arms:

Arm A—Bavituximab 3mg/kg IV over 90 minutes weekly x 2 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—Arm B—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.

Randomization:

There will be a 2:1 randomization of patients to have a 3 week lead-in treatment with bavituximab followed by combination therapy of ipilimumab + bavituximab versus ipilimumab alone. The assigned treatment will be given once subject is registered successfully.

Endpoints:

Toxicities will be assessed via NCI's CTCAE (Common Terminology Criteria for Adverse Events) v4.1 toxicity criteria. Dose limiting toxicities (DLTs) will be defined as drug-related grade 3-5 adverse events experienced within the first 12 weeks of study treatment. The maximal tolerated dose (MTD) will be exceeded if more than 30% of patients on the study experience DLTs.

DCR will be measured by irRC (Immune-related Complete Response) at weeks 15, 21, 27 using the published algorithm. Disease control rate (DCR) includes complete response (CR), Partial response (PR) and stable disease (SD). Months of survival (MOS) is measured from date of entry into protocol.

Tumor MDSC (Myeloid-Derived Suppressor Cells), TAM and Treg content will be measured by IHC (ImmunoHistoChemistry). Circulating MDSC, TAM and Treg content will be measured by flow cytometry.

Peripheral blood cytokines will be measured by EIA (EIA test is a series of blood tests for diagnosing HIV infection). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

• NCT number: NCT01984255
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Status: Terminated
• Phase: Phase 1
• Start date: April 2014
• Completion date: April 2016