Comparing 3 approaches for advanced melanoma
Official title: 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)
Interventions
Tebentafusp
Soluble gp100-specific T cell receptor with anti-CD3 scFV
Tebentafusp with Pembrolizumab
Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab
Investigators Choice
Investigators choice of therapy
Canadian Sites (3)
BC Cancer
Vancouver, British Columbia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Lady Davis Institute for Medical Research (LDI) Jewish General Hospital (JGH)
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for29 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- +Capable of giving signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocolProtocolThe detailed plan a study must follow.Read more →
- +Must agree to provide protocol specified samples for biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → analyses.
- +If applicable, must agree to use highly effective contraception
Exclusion
- −previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
- −known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV)
- −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 AEAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →
- −known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- −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 washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → from prior medications.
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 clinically significant pulmonary or cardiac disease or impaired lung or cardiac function
- −Out of range Laboratory values
- −history of allogenic tissue/solid organ transplant
- −Pregnant or lactating women
- −received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Tebentafusp, Tebentafusp with Pembrolizumab, Investigators Choice.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 540 people.
The study is currently expected to finish around July 2028.
The main measurement is taken over: Up to ~4 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Overall Survival (OS) — measured over Up to ~4 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05549297 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About TebentafuspDrug
Soluble gp100-specific T cell receptor with anti-CD3 scFV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Tebentafusp with PembrolizumabDrug
Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Investigators ChoiceDrug
Investigators choice of therapy
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to ~4 years.
The study as a whole is currently expected to finish around 2028-07.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 540 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 8 locations, including: Vancouver, British Columbia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States; Lake Success, New York, United States, and 2 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (5)
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic Minnesota
Rochester, Minnesota, 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
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.