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Phase I Integrated Biomarker Trial of VX15 / 2503 in Combination with Ipilimumab or Nivolumab in Patients with Pancreatic and Colorectal Cancer

Status
Active
Cancer Type
Colon/Rectal Cancer
Pancreatic Cancer
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03373188
Protocol IDs
Winship4142-17 (primary)
NCI-2017-01618
IRB00098707
Study Sponsor
Emory University Hospital / Winship Cancer Institute

Summary

This randomized phase I trial studies how well anti-SEMA4D monoclonal antibody VX15 / 2503 with or without ipilimumab or nivolumab work in treating patients with stage I-III pancreatic cancer that can be removed by surgery or stage IV colorectal cancer that has spread to the liver and can be removed by surgery. Monoclonal antibodies, such as anti-SEMA4D monoclonal antibody VX15 / 2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVE:
I. To evaluate the effect of the anti-SEMA4D monoclonal antibody VX15/2503 (VX15/2503) alone and VX15/2503 in combination with immune checkpoint inhibitors, ipilimumab or nivolumab, on the immune profile in the tumor microenvironment and in peripheral blood.

SECONDARY OBJECTIVES:
I. To extend the previously reported safety profile of single agent VX15/2503 to the combination of VX15/2503 and immune checkpoint inhibitors, ipilimumab or nivolumab, in patients with pancreatic and colorectal cancer.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients undergo surgery.

ARM II: Patients receive anti-SEMA4D monoclonal antibody VX15/2503 intravenously (IV) over 60 minutes on day 1. Beginning 22-36 days after administration, patients undergo surgery.

ARM III: Patients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Beginning 22-36 days after administration, patients undergo surgery.

ARM IV: Patients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes and nivolumab IV over 60 minutes on day 1. Beginning 22-36 days after administration, patients undergo surgery.

After completion of study treatment, patients are followed up at 90 days and then every 12 weeks thereafter.
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