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

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Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Advanced Melanoma

Treatments

Drug: Tebentafusp with Pembrolizumab
Drug: Tebentafusp
Drug: Investigators Choice

Study type

Interventional

Funder types

Industry

Identifiers

NCT05549297
IMCgp100-203

Details and patient eligibility

About

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

Full description

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.

Enrollment

460 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

460 participants in 3 patient groups

Arm A
Experimental group
Description:
Tebentafusp as single agent
Treatment:
Drug: Tebentafusp
Arm B
Experimental group
Description:
Tebentafusp in combination with Pembrolizumab
Treatment:
Drug: Tebentafusp with Pembrolizumab
Arm C
Experimental group
Description:
Straight to on protocol survival follow up including investigators choice of therapy
Treatment:
Drug: Investigators Choice

Trial contacts and locations

71

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Central trial contact

Immunocore Medical Information EU; Immunocore Medical Information

Data sourced from clinicaltrials.gov

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