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

Study Purpose

To evaluate the efficacy and safety of tebentafusp-based regimens tebentafusp monotherapy and in combination with anti-PD1 vs.#46;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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05549297
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Immunocore Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Austria, Belgium, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Melanoma

Additional 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.

Arms & Interventions

Arms

Experimental: Arm A

Tebentafusp as single agent

Experimental: Arm B

Tebentafusp in combination with Pembrolizumab

Experimental: Arm C

Straight to on protocol survival follow up including investigators choice of therapy

Interventions

Drug: - Tebentafusp

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

Drug: - Tebentafusp with Pembrolizumab

soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with Pembrolizumab

Drug: - Investigators Choice

Investigators choice of therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Arizona, Phoenix, Arizona

Status

Recruiting

Address

Mayo Clinic Arizona

Phoenix, Arizona, 85054

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