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

PHASE2PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 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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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-12-19

Primary completion: 2026-12-01

Study completion finish: 2027-09-01

Study type

TREATMENT

Phase

PHASE2

PHASE3

Trial ID

NCT05549297

Intervention or treatment

DRUG: Tebentafusp

DRUG: Tebentafusp with Pembrolizumab

DRUG: Investigators Choice

Conditions

• Advanced Melanoma

Condition: Advanced Melanoma
DRUG: Tebentafusp and other drugs
Wollstonecraft, New South Wales, Australia and more
Sponsor: Immunocore Ltd

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Find a site

Closest Location:

Melanoma Institute Australia

Research sites nearby

Select from list below to view details:

Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Alfred Health
Melbourne, Victoria, Australia
Gallipoli Medical Research Foundation (GMRF)
Greenslopes, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm A Tebentafusp as single agent	DRUG: Tebentafusp soluble gp100-specific T cell receptor with anti-CD3 scFV
EXPERIMENTAL: Arm B Tebentafusp in combination with Pembrolizumab	DRUG: Tebentafusp with Pembrolizumab soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with Pembrolizumab
EXPERIMENTAL: Arm C Straight to on protocol survival follow up including investigators choice of therapy	DRUG: Investigators Choice Investigators choice of therapy

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Phase 2 Primary	ctDNA reduction on treatment relative to baseline	from randomization to approximately 9 weeks
Phase 2 Primary	Overall Survival	from randomization to approximately 2 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Safety: Adverse Events and Severe Adverse Events	Incidence and severity of AEs, SAEs and changes from baseline in laboratory parameters, vital signs, and ECGs	from first dose to approximately 2 years
Safety: Tolerability	Dose Interruptions and discontinuations; Dose Reductions	from first dose to approximately 2 years
Serum Pharmacokinetics	Tebentafusp concentration. Tebentafusp PK parameters (eg, Cmax, Tmax, Cavg, t1/2)	from first dose to approximately 2 years
Phase 2 Secondary	Incidence of anti-tebentafusp antibodies	from first dose to approximately 2 years

Frequently Asked Questions

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References

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