Metastatic uveal melanoma with resectable liver metastasis and absence of extra-liver disease
Conditions
Brief summary
The primary endpoint for NEO-TB trial is the pathological complete response (pCR) rate, defined as no presence of residual disease assessed by biopsy or surgical resection at 7 months (+/- 1 month) after the start of the scheduled tratment with tebentafusp. Patients with CR according to RECIST after 6 months who do not enter surgery phase and continue treatment with tebentafusp will be considered as achieving pCR as well.
Detailed description
Secondary efficacy endpoints: ● Objecitve response rate (ORR) according to RECIST 1.1 ● Disease control rate (DCR) according to RECIST 1.1 ● Relapse-free survival (RFS) according to RECIST 1.1 ● Event-free survival (EFS) ● Overall survival (OS), Secondary safety endpoints: ● Adverse events (AE) ● Treatment-related AEs (TRAEs), Exploratory endpoints:●Molecular biomarkers determined from liver biopsies at baseline and fresh samples from liver resections in lesions with viable tumors and samples of peripheral blood, Exploratory endpoints: ●Central assessment of TCR populations and peripheral lymphocytes memory cells in blood samples before/after tebentafusp and in the prospective fresh samples from liver resections, Exploratory endpoints: ●Correlation between ctDNA levels and presence of CTCs in blood samples at several time points and clinical efficacy and safety outcomes
Interventions
Sponsors
Grupo Espanol Multidisciplinar De Melanoma
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for NEO-TB trial is the pathological complete response (pCR) rate, defined as no presence of residual disease assessed by biopsy or surgical resection at 7 months (+/- 1 month) after the start of the scheduled tratment with tebentafusp. Patients with CR according to RECIST after 6 months who do not enter surgery phase and continue treatment with tebentafusp will be considered as achieving pCR as well. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints: ● Objecitve response rate (ORR) according to RECIST 1.1 ● Disease control rate (DCR) according to RECIST 1.1 ● Relapse-free survival (RFS) according to RECIST 1.1 ● Event-free survival (EFS) ● Overall survival (OS), Secondary safety endpoints: ● Adverse events (AE) ● Treatment-related AEs (TRAEs), Exploratory endpoints:●Molecular biomarkers determined from liver biopsies at baseline and fresh samples from liver resections in lesions with viable tumors and samples of peripheral blood, Exploratory endpoints: ●Central assessment of TCR populations and peripheral lymphocytes memory cells in blood samples before/after tebentafusp and in the prospective fresh samples from liver resections, Exploratory endpoints: ●Correlation between ctDNA levels and presence of CTCs in blood samples at several time points and clinical efficacy and safety outcomes | — |
Countries
Germany, Spain
Outcome results
None listed