Clinical Trials

Inclusion Criteria:

- HLA-A*02:01-positive.

- unresectable Stage III or Stage IV non-ocular melanoma

- archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not
previously irradiated has been provided.

- measurable or non-measurable disease per RECIST 1.1

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- If applicable, must agree to use highly effective contraception

- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the Informed Consent (ICF) and protocol

Exclusion Criteria:

- Pregnant or lactating women

- diagnosis of ocular or metastatic uveal melanoma

- history of a malignant disease other than those being treated in this study

- ineligible to be retreated with pembrolizumab due to a treatment-related AE

- known untreated or symptomatic central nervous system (CNS) metastases and/or
carcinomatous meningitis

- previous severe hypersensitivity reaction to treatment with another monoclonal
antibody (mAb)

- active autoimmune disease requiring immunosuppressive treatment

- clinically significant medical condition

- known psychiatric or substance abuse disorders

- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal
T-cell receptor Against Cancer (ImmTAC) medication

- received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb,
ipilimumab, and BRAF TKI regimen) within 14 days of first dose

- received cellular therapies within 90 days of first dose

- received systemic treatment with steroids or any other immunosuppressive drug within 2
weeks of first dose

- have not progressed on treatment with an anti-PD(L)1 mAb

- have not received prior ipilimumab

- a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen

- currently participating or have participated in a study of an investigational agent or
using an investigational device within 30 days of the first dose

- known history of chronic viral infections

- Out of range Laboratory values

- history of allogenic tissue/solid organ transplant

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/25/23. Questions regarding updates should be directed to the study team contact.