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Official Title
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Phase
Phase 3
Sponsor
Immunocore Ltd
Enrollment
540
Timeline
Dec 2022 → Jul 2028
About This Study
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including 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.
Eligibility Criteria
Inclusion Criteria
- 1HLA-A\*02:01-positive
- 2unresectable Stage III or Stage IV non-ocular melanoma
- 3archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
- 4measurable or non-measurable disease per RECIST 1.1
- 5Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- 6If applicable, must agree to use highly effective contraception
- 7Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
- 8Must agree to provide protocol specified samples for biomarker analyses.
Exclusion Criteria
- 1Pregnant or lactating women
- 2diagnosis of ocular or metastatic uveal melanoma
- 3history of a malignant disease other than those being treated in this study
- 4ineligible to be retreated with pembrolizumab due to a treatment-related AE
- 5known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- 6previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
- 7active autoimmune disease requiring immunosuppressive treatment
- 8clinically significant cardiac or pulmonary disease or impaired cardiac function
- 9known psychiatric or substance abuse disorders
- 10received 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.
- 11received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
- 12received cellular therapies within 90 days of study intervention
- 13ongoing 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
- 14received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
- 15have not progressed on treatment with an anti-PD(L)1 mAb
- 16have not received prior treatment with an approved anti-CTLA-4 mAb
- 17a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
- 18currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
- 19known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV)
- 20known clinically significant pulmonary or cardiac disease or impaired lung or cardiac function
- 21Out of range Laboratory values
- 22history of allogenic tissue/solid organ transplant
Locations
72 sites participating in this study
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
Mayo Clinic Arizona
Phoenix, Arizona 85054
Mayo Clinic Florida
Jacksonville, Florida 32224
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →