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Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
Trial ID or NCT#
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
- 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
- 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
Contact us to find out if this trial is right for you.
CONTACT
Phuong Pham
(650) 725-9810
View on ClinicalTrials.gov
About this Clinical Trial
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
Your Message Will Go To
Phuong Pham650-725-9810