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

Trial ID or NCT#

NCT03070392

Status

RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 99 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

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

View All Criteria

CONTACT

Phuong Pham
(650) 725-9810

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

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

CONTACT

About this Clinical Trial

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

Trial ID or NCT#

Status

Purpose

Official Title

Eligibility Criteria

CONTACT

About this Clinical Trial

Your Message Will Go To

To: