Melanoma Metastasized to the Brain and Steroids
Recruiting · NCT03563729 · Interventional (participants receive a specific treatment) · Lead sponsor: Inge Marie Svane
View the official record on ClinicalTrials.gov →Interventions studied
BinimetinibDabrafenibEncorafenibIpilimumab Injection [Yervoy]Nivolumab Injection [Opdivo]Pembrolizumab Injection [Keytruda]Trametinib
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- 18 years of age or older
- Performance status 0-2
- Able to undergo MRI with gadolinium contrast agent
- Adequate hematological and organ function
- No significant toxicity from previous cancer treatments (CTC\<1)
- Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives
- Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition documented vasectomy and sterility or double barrier contraception are considered effective contraceptives
- Signed statement of consent after receiving oral and written study information.
- Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.
- For arm E specifically: Tumor cells must harbor BRAF mutation.
Exclusion criteria
- 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
- Acute or chronic infections with HIV or hepatitis
- Any medical condition that will interfere with patient compliance or safety
- Prior treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the metastatic setting
- Prior systemic treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the adjuvant setting, unless completed more than 6 months before enrolment in this study
- Simultaneous treatment with other experimental drugs or other anti-cancer drugs
- Pregnant or breastfeeding females.
- For arm E specifically: Prior treatment with BRAF/MEK inhibitors.
Where it is running
3 locations listed.
- Herlev Universityhospital - Herlev, Capital Region, Denmark
- Aarhus Universityhospital - Aarhus, Midt, Denmark
- Odense Universityhospital - Odense, Syd, Denmark