drugset / Trial / NCT02374242
Anti-PD 1 Brain Collaboration for Patients With Melanoma Brain Metastases
Phase 2
Active not recruiting
76 enrolled
Melanoma Institute Australia
Bristol-Myers Squibb · collabMelanoma and Skin Cancer Trials Limited · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this research project is to test the effectiveness of nivolumab versus nivolumab together with ipilimumab for the treatment of melanoma brain metastases. Patients are eligible to join this study if they are aged 18 years or above and have been diagnosed with melanoma with brain metastases.
Timeline
- Start
- 2014-11-04
- Primary completion
- 2017-09-04
- Completion
- 2028-12
Publications
- Long GV, Atkinson V, Lo SN, Guminski AD, Sandhu SK, Brown MP, Gonzalez M, McArthur GA, Menzies AM. Ipilimumab plus nivolumab versus nivolumab alone in patients with melanoma brain metastases (ABC): 7-year follow-up of a multicentre, open-label, randomised, phase 2 study. Lancet Oncol. 2025 Mar;26(3):320-330. doi: 10.1016/S1470-2045(24)00735-6. Epub 2025 Feb 17.
- Thompson JR, Lai-Kwon J, Morton RL, Guminski AD, Gonzalez M, Atkinson V, Sandhu S, Brown MP, Menzies AM, McArthur GA, Lo SN, Long GV, Bartula I. Health-related quality of life in patients with melanoma brain metastases treated with immunotherapy. Immunotherapy. 2023 Jun;15(8):593-610. doi: 10.2217/imt-2022-0262. Epub 2023 May 2.
- Long GV, Atkinson V, Lo S, Sandhu S, Guminski AD, Brown MP, Wilmott JS, Edwards J, Gonzalez M, Scolyer RA, Menzies AM, McArthur GA. Combination nivolumab and ipilimumab or nivolumab alone in melanoma brain metastases: a multicentre randomised phase 2 study. Lancet Oncol. 2018 May;19(5):672-681. doi: 10.1016/S1470-2045(18)30139-6. Epub 2018 Mar 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ipilimumab | Monoclonal antibody | 3 mg/kg | — |
| Comparator | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |