Cancer Type: Neurologic Oncology
Study Type: Treatment
Phase: Early Phase I
Principal Investigator: Forsyth, Peter
A Randomized, Pilot Study to Evaluate the Molecular and Cellular Response to Treatment with Nivolumab with either Adjuvant Ipilimumab or Relatlimab in Adult Patients with Surgically Resectable Melanoma Brain Metastases
The purpose of this pilot study is to determine the safety and feasibility of giving a single dose of Nivolumab with Ipilimumab or Relatlimab in participants with brain metastases from melanoma who can undergo surgery for removal of their brain metastases 7- 10 days after receiving the study drug.
Primary Objectives: To establish the safety and feasibility of doing surgical resection in patients with MBM in 7-10 days after initial treatment with a single dose of Nivo+Ipi or Nivo+Rela. To estimate the immune cell population differences among the treatment arms. Secondary Objectives: To characterize and compare the immune landscape in the MBM versus systemic disease, serum, and CSF. To evaluate the association between cellular compositions of the MBM TME and CNS clinical response (defined based on RANO-BM and i-RANO). To evaluate the association between cellular compositions of the MBM TME and extracranial clinical benefit and global clinical benefit rate (defined based on RECIST 1.1). To evaluate association between the immune landscape in the MBM and overall survival (OS), progression free survival (PFS), and adverse events (AE s) from ICI s.
Immunotherapy; Radiotherapy; Surgery
BMS-936558 (Nivolumab); BMS-986016 (Relatlimab); Ipilimumab (); Nivolumab (Opdivo); Radiotherapy (); Relatlimab (); Yervoy (Ipilimumab)
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
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