NCT03563729 Melanoma Metastasized to the Brain and Steroids
| NCT ID | NCT03563729 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Inge Marie Svane |
| Condition | Malignant Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2018-06-06 |
| Primary Completion | 2024-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2018-06-06 with a primary completion date of 2024-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Troels H Borch, PhD
PRINCIPAL INVESTIGATOR
Center for Cancer Immune Therapy, Department of Hematology and Department of Oncology
Frequently Asked Questions
Who can join the NCT03563729 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03563729 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03563729 currently recruiting?
Yes, NCT03563729 is actively recruiting participants. Contact the research team at inge.marie.svane@regionh.dk for enrollment information.
Where is the NCT03563729 trial being conducted?
This trial is being conducted at Herlev, Denmark, Aarhus, Denmark, Odense, Denmark.
Who is sponsoring the NCT03563729 clinical trial?
NCT03563729 is sponsored by Inge Marie Svane. The principal investigator is Troels H Borch, PhD at Center for Cancer Immune Therapy, Department of Hematology and Department of Oncology. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.