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

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