Actively Recruiting
Melanoma Metastasized to the Brain and Steroids
Led by Inge Marie Svane · Updated on 2023-07-13
80
Participants Needed
3
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
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).
CONDITIONS
Official Title
Melanoma Metastasized to the Brain and Steroids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Age 18 years or older
- Performance status of 0 to 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 must have a negative serum pregnancy test and use effective contraception from screening until 6 months after treatment
- Men with female partners of childbearing potential must use effective contraception from screening until 6 months after treatment
- Signed informed consent after receiving study information
- Willingness and ability to participate in treatment, follow-up, and manage toxicities
- For arm E only: Tumor cells must have BRAF mutation
You will not qualify if you...
- Presence of another or concurrent malignancy unless disease-free for 3 years
- Diagnosis of ocular melanoma
- Neurological symptoms from brain metastases at baseline despite steroid treatment, unless due to prior surgery
- Known allergy to any study drug or its components
- Acute or chronic infections with HIV or hepatitis
- Any medical condition that could interfere with safety or compliance
- Prior treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the metastatic setting
- Prior adjuvant treatment with these antibodies unless completed more than 6 months before enrollment
- Concurrent treatment with other experimental or anti-cancer drugs
- Pregnancy or breastfeeding
- For arm E only: Prior treatment with BRAF/MEK inhibitors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Herlev Universityhospital
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
2
Aarhus Universityhospital
Aarhus, Midt, Denmark, 8000
Not Yet Recruiting
3
Odense Universityhospital
Odense, Syd, Denmark, 5000
Not Yet Recruiting
Research Team
I
Inge M Svane, Professor
CONTACT
T
Troels H Borch, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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