Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma

Status: Active

Description

To evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

Eligibility Criteria

Inclusion Criteria

  • Male or female patients age ≥ 18 years of age at the time of informed consent
  • Ability to provide and understand written informed consent prior to any study procedures
  • Histologically or cytologically confirmed metastatic UM
  • No prior systemic therapy in the metastatic or advanced setting
  • No prior local, liver-directed therapy; prior surgical resection of oligometastatic liver disease is allowed
  • Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease

Exclusion Criteria

  • Impaired baseline organ function as evaluated by out-of-range laboratory values
  • History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
  • Clinically significant cardiac disease or impaired cardiac function
  • Presence of symptomatic or untreated central nervous system (CNS) metastases
  • Active infection requiring systemic antibiotic therapy
  • Known history of human immunodeficiency virus infection (HIV)
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Malignant disease, other than that being treated in this study
  • Patients receiving systemic steroid therapy or any other systemic immunosuppressive medication. Local steroid therapies are acceptable
  • History of adrenal insufficiency, pneumonitis, interstitial lung disease, or inflammatory bowel disease
  • Major surgery within 2 weeks of the first dose of study drug
  • Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field
  • Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug
  • Pregnant, likely to become pregnant, or lactating women

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Ryan Joseph Sullivan
Phone: 617-724-4000

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Trial Objectives and Outline

This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A*0201 positive adult patients with advanced UM treated in the first line setting with no prior systemic or liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior surgical resection of liver metastases and adjuvant systemic therapy are acceptable). Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR).

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Immunocore Ltd

Trial IDs

Primary ID IMCgp100-202
Secondary IDs NCI-2017-00590
Clinicaltrials.gov ID NCT03070392