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



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:2/14/2019
Start Date:October 16, 2017
End Date:March 2023
Contact:Rachael Easton, MD, PhD
Email:clinicaltrials@immunocore.com
Phone:484-534-5261

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A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma

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.

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).

Inclusion Criteria:

1. Male or female patients age ≥ 18 years of age at the time of informed consent

2. Ability to provide and understand written informed consent prior to any study
procedures

3. Histologically or cytologically confirmed metastatic UM

4. No prior systemic therapy in the metastatic or advanced setting

5. No prior local, liver-directed therapy; prior surgical resection of oligometastatic
liver disease is allowed

6. Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative
setting in patients with localized disease

Exclusion Criteria:

1. Impaired baseline organ function as evaluated by out-of-range laboratory values

2. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs
or monoclonal antibodies

3. Clinically significant cardiac disease or impaired cardiac function

4. Presence of symptomatic or untreated central nervous system (CNS) metastases

5. Active infection requiring systemic antibiotic therapy

6. Known history of human immunodeficiency virus infection (HIV)

7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

8. Malignant disease, other than that being treated in this study

9. Patients receiving systemic steroid therapy or any other systemic immunosuppressive
medication. Local steroid therapies are acceptable

10. History of adrenal insufficiency, pneumonitis, interstitial lung disease, or
inflammatory bowel disease

11. Major surgery within 2 weeks of the first dose of study drug

12. Radiotherapy within 2 weeks of the first dose of study drug, with the exception of
palliative radiotherapy to a limited field

13. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2
weeks prior to start of study drug

14. Pregnant, likely to become pregnant, or lactating women
We found this trial at
21
sites
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Mohammed Milhem, MD
Phone: 319-356-2324
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ryan Sullivan, MD
Phone: 617-724-4000
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Boston, MA
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Igor Puzanov, MD
Phone: 615-322-4225
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Principal Investigator: Melinda Yushak, MD
Phone: 404-778-4500
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, GA
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Aurora, Colorado 80045
Principal Investigator: Matthew Rioth, MD
Phone: 720-848-0300
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Aurora, CO
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Ryan Sullivan, MD
Phone: 617-724-4000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chicago, Illinois 60637
Principal Investigator: Jason Luke, MD
Phone: 855-702-8222
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Chicago, IL
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Sunandana Chandra, MD
Phone: 312-472-1234
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Chicago, IL
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Kari Kendra, MD
Phone: 614-293-7642
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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390 Victoria Street
Darlinghurst, New South Wales 2010
Principal Investigator: Anthony Joshua, MD
Phone: 61 2 9355 5618
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Darlinghurst,
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Durham, North Carolina
Principal Investigator: April Salama, MD
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Durham, NC
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Bartosz Chmielowski, MD
Phone: 310-794-4955
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Los Angeles, CA
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Los Angeles, California 90025
Principal Investigator: Omid Hamid, MD
Phone: 310-294-0438
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Miami Beach, Florida 33140
Principal Investigator: Jose Lutzky, MD
Phone: 305-674-2625
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Miami Beach, FL
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Richard Carvajal, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Alex Shoushtari, MD
Phone: 646-888-4161
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Palo Alto, California 94303
Principal Investigator: Sunil Reddy, MD
Phone: 650-723-2669
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Palo Alto, CA
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Marlana Orloff, MD
Phone: 215-955-8745
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: John Kirkwood, MD
Phone: 412-623-7707
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Portland, Oregon 97213
Principal Investigator: Brendan Curti, MD
Phone: 503-215-2612
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Portland, OR
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Kevin Kim, MD
Phone: 415-885-8600
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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