Comparing tebentafusp treatment to standard care for advanced melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 clinical trial evaluates the efficacy and safety of tebentafusp, both as a standalone treatment and in combination with pembrolizumab, against the investigator's choice of standard care in patients with advanced non-ocular melanoma who have previously undergone treatment. The study is multicenter and open-label, focusing on patients who have progressed after prior anti-PD(L)1 and anti-CTLA4 therapies. Participants must provide tumor samples for biomarker analysis and meet specific eligibility criteria related to their disease stage and performance status.

Why it matters

Who can join: the full rules

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 (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 treatment with an approved anti-CTLA-4 mAb
* have 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)
* known clinically significant pulmonary or cardiac disease or impaired lung or cardiac function
* Out of range Laboratory values
* history of allogenic tissue/solid organ transplant

Where it's running

• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• Orlando Health Cancer Institute
  Orlando, Florida, United States Recruiting
• Winship Cancer Institute of Emory University
  Atlanta, Georgia, United States Recruiting
• University of Kansas Cancer Center - Westwood
  Westwood, Kansas, United States Recruiting
• St Elizabeth Healthcare (St Elizabeth Medical Center)
  Edgewood, Kentucky, United States Recruiting

+32 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Immunocore Medical Information
• Email: medical.information@immunocore.com
• Phone: 844-466-8661

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.