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

ConditionAdvanced Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunocore Ltd

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tebentafusp

    Drug

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

  • Tebentafusp with Pembrolizumab

    Drug

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

  • Investigators Choice

    Drug

    Investigators choice of therapy

Treatment groups

540 Participants
are divided into 3 treatment groups
Group A: Arm A: Tebentafusp MonotherapyExperimental treatment 1 intervention
Group B: Arm B: Tebentafusp + PembrolizumabExperimental treatment 1 intervention
Group C: Arm C: Investigator's ChoiceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

OS is the time from randomization to death due to any cause.

Time frame
Up to ~4 years

Secondary outcomes

1

Change from Baseline in Circulating Tumor DNS (ctDNA)

Change from baseline in ctDNA will be assessed.

Time frame
Up to ~9 weeks
2

Number of participants with ≥1 adverse event (AE)

Number of participants with AEs.

Time frame
Up to ~4 years
3

Number of participants with ≥1 serious adverse event (SAEs)

Number of participants with SAEs.

Time frame
Up to ~4 years
4

Number of participants with dose interruptions, reductions, and discontinuations from study therapy due to AEs

Number of participants with tolerability issues.

Time frame
Up to ~4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immunocore Ltd

Lead sponsor

Source ClinicalTrials.gov
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