Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator’s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)

ENROLLING
Protocol # :
22-500
Conditions
Advanced Melanoma
Phase
II/III
Disease Sites
Melanoma, Skin
Principal Investigator
Sullivan, Ryan, Joseph

Trial Description

To evaluate the efficacy and safety of tebentafusp-based regimens tebentafusp monotherapy and
in combination with anti-PD1 vs investigator choice (including clinical trials of
investigational agents, salvage therapy per local standard of care (SoC), best supportive
care (BSC)) on protocol survivor follow up) in patients with advanced non-ocular melanoma

Eligibility Requirements

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

- Must agree to provide protocol specified samples for biomarker analyses.

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 with clinically
significant cardiac disease or impaired cardiac function

- known psychiatric or substance abuse disorders

- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal
T-cell receptor Against Cancer (ImmTAC) medication who have not completed adequate
washout from prior medications.

- 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 study intervention

- ongoing Common Terminology Criteria for Adverse Events(CTCAE) Grade ≥ 2 clinically
significant who in the opinion of the investigator could affect the outcome of the
study

- 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 such as hepatitis B virus (HBV) or hepatitis
C virus (HCV)

- Out of range Laboratory values

- history of allogenic tissue/solid organ transplant

22-500