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Clinical Trials in Denmark / NCT03563729
Recruiting Phase 2

Melanoma Metastasized to the Brain and Steroids

NCT03563729 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2
Started
2018-06-06
Last updated
2023-07-13

Condition(s) studied

Malignant Melanoma

Investigational drug(s) / intervention(s)

Pembrolizumab Injection [Keytruda] →Ipilimumab Injection [Yervoy] →Nivolumab Injection [Opdivo] →Encorafenib →Binimetinib →Dabrafenib →Trametinib →

Pembrolizumab Injection [Keytruda]: Alone

Ipilimumab Injection [Yervoy]: In combination with nivolumab.

Nivolumab Injection [Opdivo]: In combination with ipilimumab.

Encorafenib: In combination with binimetinib

Binimetinib: In combination with encorafenib

Dabrafenib: In combination with dabrafenib

Trametinib: In combination with trametinib

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Herlev Universityhospital Herlev Capital Region Recruiting
Aarhus Universityhospital Aarhus Midt Not Yet Recruiting
Odense Universityhospital Odense Syd Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03563729 on ClinicalTrials.gov ↗ ← All trials in Denmark