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“A phase II randomized non-comparative study, with NEOadjuvant plus adjuvant Therapy with combination or sequence of vemurafenib, cobImetinib, and atezolizuMab in patients with high-risk, surgically resectable BRAF mutated and wild-type Melanoma”

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516659-41-00
Acronym
NEO-TIM
Enrollment
94
Registered
2024-09-30
Start date
2020-10-12
Completion date
Unknown
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high-risk, surgically resectable BRAF mutated and wild-type Melanoma

Brief summary

The primary objective is to determine the pathologic complete response (pCR) rate. (Centrally/Independently determined). Pathologic complete response, which is defined as residual cancer burden 0.

Detailed description

Recurrence-Free Survival (RFS) at 2-years, 3-years and at the end of the study. RFS defined as the time from randomisation to recurrence event (local or distant disease development, or death). For patients without events at the end of the study time will be censored at the date of last follow-up., Overall Survival (OS) defined as the time from randomisation to death. For patients alive at the end of the study time will be censored at the date of last follow-up., Pathological Overall Response rate (pORR) defined as the sum of pathologic complete responses (pCRs), near pathologic complete responses (near pCRs) and pathologic partial responses (pPRs)., Safety, To determine molecular and immunophenotypic changes in tumour and peripheral blood evaluating several biomarkers.

Interventions

DRUGATEZOLIZUMAB
DRUGCOBIMETINIB
DRUGVEMURAFENIB

Sponsors

Fondazione Melanoma Onlus
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary objective is to determine the pathologic complete response (pCR) rate. (Centrally/Independently determined). Pathologic complete response, which is defined as residual cancer burden 0.

Secondary

MeasureTime frame
Recurrence-Free Survival (RFS) at 2-years, 3-years and at the end of the study. RFS defined as the time from randomisation to recurrence event (local or distant disease development, or death). For patients without events at the end of the study time will be censored at the date of last follow-up., Overall Survival (OS) defined as the time from randomisation to death. For patients alive at the end of the study time will be censored at the date of last follow-up., Pathological Overall Response rate (pORR) defined as the sum of pathologic complete responses (pCRs), near pathologic complete responses (near pCRs) and pathologic partial responses (pPRs)., Safety, To determine molecular and immunophenotypic changes in tumour and peripheral blood evaluating several biomarkers.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026