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New treatment option for Malignant Melanoma
Official title Melanoma Metastasized to the Brain and Steroids
ClinicalTrials.gov ID: NCT03563729
What this study is testing
What is Pembrolizumab Injection [Keytruda]?
Pembrolizumab Injection [Keytruda] is an investigational medicine, being studied as a potential treatment for malignant melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- At least one measurable lesion according to RECIST version 1.1 guidelines
- Evaluable intracranial disease
- 18 years of age or older
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Herlev, Capital Region, Denmark
- Aarhus, Midt, Denmark
- Odense, Syd, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herlev, Capital Region, Denmark; Aarhus, Midt, Denmark; Odense, Syd, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.