Trial Details

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)

NCT05549297

RECRUITING

DESCRIPTION

The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including 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.

CONDITIONS

ELIGIBILITY CRITERIA

• 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
• clinically significant cardiac or pulmonary 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 or 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 treatment with an approved anti-CTLA-4 mAb
• 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)
• known clinically significant pulmonary or cardiac disease or impaired lung or cardiac function
• Out of range Laboratory values
• history of allogenic tissue/solid organ transplant