Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Immunocore Ltd (Voir sur ClinicalTrials)
décembre 2022
juillet 2028
24 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline ROBERT | 29/05/2024 08:24:10 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69373 - Lyon - Cedex - France | Contact (sur clinicalTrials) | ||||
| CHU de Bordeaux - Hopital Saint Andre - 22075 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Timone [Recruiting] - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Lous - APHP - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institute Claudius Regaud - 31059 - Toulouse - Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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