Title: A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator s 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.

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. Must meet the following criteria related to prior treatment:

- No prior systemic therapy in the metastatic or advanced setting including
chemotherapy, immunotherapy, or targeted therapy

- No prior regional, liver-directed therapy including chemotherapy, radiotherapy,
or embolization

- Prior surgical resection of oligometastatic disease is allowed

- Prior neoadjuvant or adjuvant therapy is allowed provided administered in the
curative setting in patients with localized disease. Patients may not be
re-treated with an Investigator's Choice therapy that was administered as
adjuvant or neoadjuvant treatment. Additionally, patients who have received
nivolumab as prior adjuvant/neoadjuvant treatment should not receive
pembrolizumab as Investigator's Choice therapy.

5. HLA A*0201 positive by central assay

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening

7. Patients have measurable disease or non-measurable disease according to RECIST v1.1

8. All other relevant medical conditions must be well-managed and stable, in the opinion
of the investigator, for at least 28 days prior to first administration of study drug

Exclusion Criteria

1. 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, or CNS
metastases that require doses of corticosteroids within the prior 3 weeks to study Day
1. Patients with brain metastases are eligible if lesions have been treated with
localized therapy and there is no evidence of PD for at least 4 weeks by magnetic
resonance imaging (MRI) prior to the first dose of study drug

5. Active infection requiring systemic antibiotic therapy. Patients requiring systemic
antibiotics for infection must have completed therapy at least 1 week prior to the
first dose of study drug

6. Known history of human immunodeficiency virus infection (HIV). Testing for HIV status
is not necessary unless clinically indicated

7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional
protocol. Testing for HBV or HCV status is not necessary unless clinically indicated
or the patient has a history of HBV or HCV infection

8. Malignant disease, other than that being treated in this study. Exceptions to this
exclusion include the following: malignancies that were treated curatively and have
not recurred within 2 years prior to study treatment; completely resected basal cell
and squamous cell skin cancers; any malignancy considered to be indolent and that has
never required therapy; and completely resected carcinoma in situ of any type

9. Any medical condition that would, in the investigator's or Sponsor's judgment, prevent
the patient's participation in the clinical study due to safety concerns, compliance
with clinical study procedures or interpretation of study results

10. Patients receiving systemic steroid therapy or any other systemic immunosuppressive
medication at any dose level, as these may interfere with the mechanism of action of
study treatment. Local steroid therapies (eg, otic, ophthalmic, intra-articular, or
inhaled medications) are acceptable

11. History of adrenal insufficiency

12. History of interstitial lung disease

13. History of pneumonitis that required corticosteroid treatment or current pneumonitis

14. History of colitis or inflammatory bowel disease

15. Major surgery within 2 weeks of the first dose of study drug (minimally invasive
procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access
device, and insertion of a feeding tube are not considered major surgery and are not
exclusionary)

16. Radiotherapy within 2 weeks of the first dose of study drug, with the exception of
palliative radiotherapy to a limited field, such as for the treatment of bone pain or
a focally painful tumor mass

17. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ≤ 2
weeks prior to start of study drug. An erythroid-stimulating agent is allowed as long
as it was initiated at least 2 weeks prior to the first dose of study treatment and
the patient is not red blood cell transfusion dependent

18. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as
the state of a female after conception and until the termination of gestation)

19. Women of childbearing potential who are sexually active with a non-sterilized male
partner, defined as all women physiologically capable of becoming pregnant, unless
they are using highly effective contraception during study treatment (defined in
Section 6.7), and must agree to continue using such precautions for 6 months after the
final dose of investigational product; cessation of birth control after this point
should be discussed with a responsible physician. Highly effective methods of
contraception are described in Section 6.7

20. Male patients must be surgically sterile or use double barrier contraception methods
from enrollment through treatment and for 6 months following administration of the
last dose of study drug

21. Patients who are in an institution due to official or judicial order.

22. Patients who are the investigator or any subinvestigator, research assistant,
pharmacist, study coordinator, or other staff thereof, directly involved in the
conduct of the study.

23. Contraindication for treatment with Investigator's Choice alternatives (dacarbazine,
ipilimumab and pembrolizumab) as per applicable labelling. Patient may have a
contraindication to 1 or 2 of the choices if he/she is a candidate for dosing with at
least 1 Investigator's Choice and meets all other study eligibility criteria.