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RECRUITINGPhase 3INTERVENTIONAL

Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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-tumors that can be measured on scans 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 willing to sign a consent form which includes compliance with the requirements and restrictions listed in the willing to sign a consent form (ICF) and protocol - Must agree to provide protocol specified samples for biomarker analyses. Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body) requiring immunosuppressive treatment - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 * 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 * have 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

Treatments Being Tested

DRUG

Tebentafusp

Soluble gp100-specific T cell receptor with anti-CD3 scFV

DRUG

Tebentafusp with Pembrolizumab

Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab

DRUG

Investigators Choice

Investigators choice of therapy

Locations (20)

Mayo Clinic Arizona
Phoenix, Arizona, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
St Elizabeth Healthcare (St Elizabeth Medical Center)
Edgewood, Kentucky, United States
St Elizabeth Healthcare (St Elizabeth Medical
Edgewood, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Northwell Health Cancer Institute - Zuckerberg Cancer Center
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Thomas Jefferson University Medical Oncology Clinic
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States