Melanoma Metastasized to the Brain and Steroids

Sponsor
Inge Marie Svane
Study ID
NCT03563729
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\> 10 \< 25 mg prednisolone or \> 25 mg prednisolone) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).

Key Dates

Start date
Jun 6, 2018
Status verified
Jul 2023
Primary completion
Jun 1, 2024
Completion
Jun 6, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: B: Pembrolizumab (Prednisolone >10 mg)
    Intravenous infusion of pembrolizumab 2 mg/kg every third week for up to two years.
  • Experimental: C: Ipilimumab/nivolumab (Prednisolone 11-25 mg)
    Intravenous infusion of ipilimumab 3 mg/kg and nivolumab 1 mg/kg four times every three weeks in the induction phase and nivolumab 480 mg every four weeks in the maintenance phase for up to two years.
  • Experimental: D: Ipilimumab/nivolumab (Prednisolone >25 mg)
    Intravenous infusion of ipilimumab 3 mg/kg and nivolumab 1 mg/kg four times every three weeks in the induction phase and nivolumab 480 mg every four weeks in the maintenance phase for up to two years.
  • Experimental: E: BRAF/MEK -> ipi/nivo (prednisolone >10 mg)
    Induction treatment with BRAF/MEK inhibitors (either the combination of encorafenib/binimetinib or dabrafenib/trametinib) orally for 28 days followed by intravenous infusion of ipilimumab 3 mg/kg and nivolumab 1 mg/kg four times every three weeks in the induction phase and nivolumab 480 mg every four weeks in the maintenance phase for up to two years.

Primary Outcome Measure

6 months progression-free survival rate [ Time Frame: 6 months ]

Central Contacts

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