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

Launched by IMMUNOCORE LTD · Sep 19, 2022

Keywords

ClinConnect Summary

The TEBE-AM clinical trial is studying a new treatment for patients with advanced melanoma, which is a serious type of skin cancer. This trial is comparing a medication called tebentafusp, both on its own and combined with another type of treatment known as anti-PD1, against a choice of treatments selected by the patient's doctor. The goal is to see how well these options work and how safe they are for patients who have already received other treatments for their melanoma.

To join the trial, participants need to have specific characteristics, such as being HLA-A*02:01-positive and having advanced melanoma that cannot be surgically removed. They should also be able to provide a tissue sample from their tumor. Eligible participants typically have good overall health with a performance status score of 0 or 1, indicating they are fully active or slightly limited. Throughout the trial, patients will receive regular follow-ups and be monitored for any side effects or changes in their condition. It's important to note that individuals who are pregnant, have certain other health issues, or have received specific previous treatments may not be eligible to participate.

Gender

ALL

Eligibility 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
• • clinically significant cardiac or pulmonary 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 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
• • 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