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EORTC 1612-MG: Combination of targeted therapy (encorafenib and binimetinib) followed by combination of immunotherapy (ipilimumab and nivolumab) vs immediate combination of immunotherapy in patients with unresectable or metastatic melanoma with BRAF V600 mutation: an EORTC randomized phase II study (EBIN)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505376-30-00
Acronym
EORTC 1612-MG
Enrollment
264
Registered
2024-06-25
Start date
2018-10-30
Completion date
Unknown
Last updated
2026-01-22

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

Conditions

BRAF V600 mutation–positive unresectable or metastatic melanoma

Brief summary

Progression-free survival (PFS): defined as the time from the date of randomization until the first date of progression, or until date of death (whatever the cause), whichever occurs first. For patients who remain alive and whose disease has not progressed, PFS will be censored on the date of last visit/contact when a disease assessment was performed. PFS will be based on the disease assessment or date of death provided by the local investigator

Detailed description

Overall survival (OS): defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of patients still alive will be censored at the moment of last visit/contact, CR rate, time to CR and duration of CR, Best overall objective response (CR+PR) rate (ORR), time to best objective reponse (OR) and duration of OR

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGYERVOY 5 mg/ml concentrate for solution for infusion

Sponsors

European Organisation For Research And Treatment Of Cancer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS): defined as the time from the date of randomization until the first date of progression, or until date of death (whatever the cause), whichever occurs first. For patients who remain alive and whose disease has not progressed, PFS will be censored on the date of last visit/contact when a disease assessment was performed. PFS will be based on the disease assessment or date of death provided by the local investigator

Secondary

MeasureTime frame
Overall survival (OS): defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of patients still alive will be censored at the moment of last visit/contact, CR rate, time to CR and duration of CR, Best overall objective response (CR+PR) rate (ORR), time to best objective reponse (OR) and duration of OR

Countries

France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

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