VX15/2503 and Immunotherapy in Resectable Pancreatic and Colorectal Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03373188
Phase
PHASE1
Status
Completed

Conditions

  • Colon Carcinoma Metastatic in the Liver
  • Colorectal Adenocarcinoma
  • Pancreatic Adenocarcinoma
  • Resectable Pancreatic Carcinoma
  • Stage I Pancreatic Cancer
  • Stage IA Pancreatic Cancer
  • Stage IB Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIB Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Colorectal Cancer
  • Stage IVA Colorectal Cancer
  • Stage IVB Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-SEMA4D Monoclonal Antibody VX15/2503 — BIOLOGICAL
    Given IV
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Surgery — PROCEDURE
    Undergo therapeutic conventional surgery

Study Details

This randomized phase I trial studies how well anti-semaphorin 4D (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.

Key Dates

Start date
Dec 15, 2017
Status verified
Mar 2024
Primary completion
Oct 28, 2021
Completion
Oct 28, 2021

Study Design

Enrollment
10 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (surgery)
    Patients undergo surgery.
  • Experimental: Arm II (VX15/2503, surgery)
    Patients receive anti-SEMA4D monoclonal antibody VX15/2503 IV over 60 minutes on day 1. Beginning 22-36 days after administration, patients undergo surgery.
  • Experimental: Arm III (VX15/2503, ipilimumab, surgery)
    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.
  • Experimental: Arm IV (VX15/2503, nivolumab, surgery)
    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.

Primary Outcome Measure

Evaluate treatment effects of the study drugs on tumor cluster of differentiation 8+ (CD8+) T cell infiltration between the treatment groups. [ Time Frame: Up to 4 years from date of last treatment dose ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-
University of Rochester Medical CenterRochesterNew York14642-

Find similar trials in Atlanta, GA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GAUniversity of Rochester Medical Center· Rochester, NY

Related Studies