NCT03563729: MEMBRAINS

Melanoma Metastasized to the Brain and Steroids

Recruiting now Phase 2 Last updated 13 July 2023

What this trial tests

Phase 2 trial testing Pembrolizumab Injection [Keytruda] in Malignant Melanoma in 80 participants. Currently enrolling.

Timeline

6 June 2018

Primary endpoint
1 June 2024

6 June 2028

Quick facts

Lead sponsor	Inge Marie Svane
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	6 June 2018
Primary completion	1 June 2024
Estimated completion	6 June 2028
Sites	3 locations across Denmark

Drugs / interventions tested

• Pembrolizumab Injection [Keytruda]
• Ipilimumab Injection [Yervoy]
• Nivolumab Injection [Opdivo]
• Encorafenib (encorafenib) — full drug profile →
• Binimetinib (binimetinib) — full drug profile →
• Dabrafenib (dabrafenib) — full drug profile →
• Trametinib (trametinib) — full drug profile →

Conditions studied

• Malignant Melanoma — all drugs for Malignant Melanoma →

Sponsor

Inge Marie Svane — full company profile →

Who can join

18 and older, any sex, with Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunotherapy of brain metastases: breaking a "dogma".
   Di Giacomo AM, Valente M, Cerase A, Lofiego MF, et al · · 2019 · cited 69× · PMID 31623643 · DOI 10.1186/s13046-019-1426-2
2. Emerging principles of brain immunology and immune checkpoint blockade in brain metastases.
   Fares J, Ulasov I, Timashev P, Lesniak MS. · · 2021 · cited 40× · PMID 33893488 · DOI 10.1093/brain/awab012
3. Emerging Immunotherapies in the Treatment of Brain Metastases.
   Nieblas-Bedolla E, Nayyar N, Singh M, Sullivan RJ, et al · · 2021 · cited 31× · PMID 33103803 · DOI 10.1002/onco.13575
4. Complications associated with immunotherapy for brain metastases.
   Tran TT, Jilaveanu LB, Omuro A, Chiang VL, et al · · 2019 · cited 28× · PMID 31577604 · DOI 10.1097/wco.0000000000000756
5. Immune Checkpoint Inhibitors for Brain Metastases: A Primer for Neurosurgeons.
   Aquilanti E, Brastianos PK. · · 2020 · cited 25× · PMID 32302389 · DOI 10.1093/neuros/nyaa095
6. Melanoma central nervous system metastases: An update to approaches, challenges, and opportunities.
   Karz A, Dimitrova M, Kleffman K, Alvarez-Breckenridge C, et al · · 2022 · cited 15× · PMID 35912544 · DOI 10.1111/pcmr.13059
7. Cancer brain metastasis: molecular mechanisms and therapeutic strategies.
   Lu Y, Huang Y, Zhu C, Li Z, et al · · 2025 · cited 9× · PMID 39998776 · DOI 10.1186/s43556-025-00251-0
8. The Analysis of Trends in Survival for Patients with Melanoma Brain Metastases with Introduction of Novel Therapeutic Options before the Era of Combined Immunotherapy-Multicenter Italian-Polish Report.
   Placzke J, Teterycz P, Quaglino P, Cybulska-Stopa B, et al · · 2022 · cited 6× · PMID 36497248 · DOI 10.3390/cancers14235763