Health TrialsbyHealthPanel

Melanoma Metastasized to the Brain and Steroids

ConditionMalignant Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInge Marie Svane

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed metastatic melanoma with radiologically verified brain metastasis

Need for systemic steroid treatment (prednisolone > 10 mg daily; dexamethasone > 1.6 mg daily, hydrocortisone > 40 mg daily or equivalent) due to brain metastasis

At least one measurable lesion according to RECIST version 1.1 guidelines

Evaluable intracranial disease

Disqualifiers

Another malignancy or concurrent malignancy unless disease-free for 3 years

Ocular melanoma

Neurological symptoms from brain metastases present at baseline despite steroid treatment, unless symptoms are related to prior surgery

Known hypersensitivity to one of the active drugs or excipients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pembrolizumab Injection [Keytruda]

    Drug

    Alone

  • Ipilimumab Injection [Yervoy]

    Drug

    In combination with nivolumab.

  • Nivolumab Injection [Opdivo]

    Drug

    In combination with ipilimumab.

  • Encorafenib

    Drug

    In combination with binimetinib

  • Binimetinib

    Drug

    In combination with encorafenib

  • Dabrafenib

    Drug

    In combination with dabrafenib

  • Trametinib

    Drug

    In combination with trametinib

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: B: Pembrolizumab (Prednisolone >10 mg)Experimental treatment 1 intervention
Group B: C: Ipilimumab/nivolumab (Prednisolone 11-25 mg)Experimental treatment 2 interventions
Group C: D: Ipilimumab/nivolumab (Prednisolone >25 mg)Experimental treatment 2 interventions
Group D: E: BRAF/MEK -> ipi/nivo (prednisolone >10 mg)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

6 months progression-free survival rate

Proportion of patients who did not progress or die within 6 months from commencing study treatment.

Time frame
6 months
2

6 months overall survival rate

Proportion of patients who did not die within 6 months from commencing study treatment.

Time frame
6 months

Secondary outcomes

1

Overall progression-free survival

Time from commencing study treatment to the date of progression or death.

Time frame
4 years
2

Overall survival

Time from commencing study treatment to the date of death from any cause.

Time frame
4 years
3

Overall response rate

Proportion of patients with an overall complete or partial response according to modified RECIST 1.1.

Time frame
4 years
4

Extracranial response rate

Proportion of patients with an overall complete or partial response in extracranial lesions according to modified RECIST 1.1.

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inge Marie Svane

Lead sponsor

Herlev Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now