Melanoma Clinical Trial
Tebentafusp Regimen Versus Investigator’s Choice in Previously Treated Advanced Melanoma (TEBE-AM)
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
This is a Phase 2/3, multicenter, open-label study to evaluate the efficacy and safety of tebentafusp as monotherapy (Arm A) and in combination with pembrolizumab (Arm B) compared with standard of care or best supportive care (Arm C) in participants with non-ocular advanced melanoma who have progressed on a prior anti-PD(L)1 regimen, received prior ipilimumab and, if the participant has a BRAF mutation, a prior BRAF tyrosine kinase inhibitor (TKI) regimen.
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.
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
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There are 9 Locations for this study
Orlando Florida, 32806, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
New Brunswick New Jersey, 08901, United States
New York New York, 10065, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15232, United States
Knoxville Tennessee, 37920, United States
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