Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) (NCT05549297) | Clinical Trial Compass
RecruitingPhase 3
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
United States, Australia, Austria540 participantsStarted 2022-12-19
Plain-language summary
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 can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (excludin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.