Ignite Creation Date:
2024-05-06 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03563729
Status:
RECRUITING
Last Update Posted:
2023-07-13
First Post:
2018-06-06
Brief Title:
Melanoma Metastasized to the Brain and Steroids
Sponsor:
Inge Marie Svane
Organization:
Herlev Hospital
Study Overview
Official Title:
Efficacy of Immunotherapy in Melanoma Patients With Brain Metastases Treated With Steroids
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEMBRAINS
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
Detailed Description:
Cancer immunotherapy with checkpoint inhibitors CPI has demonstrated significant response rates with clinical responses of exceptional duration observed in pivotal clinical trials for multiple types of solid tumors Results from clinical trials demonstrate a considerable survival benefit of CPI over standard treatments leading to registration of CPI for lung- head and neck- bladder- renal cancer lymphomas and metastatic melanoma MM To date CPI appear to hold the key for longterm survival - at least for patients treated in clinical trials
Patients enrolled in pivotal clinical trials for immunotherapy of MM are highly selected and does not include patients with brain metastases Small phase II studies lend support to CPI to yield responses in melanoma that has metastasized to the brain However a large proportion of patients that develop brain metastasis will require continued systemic treatment with steroids to alleviate symptoms from the central nervous system CNS This group of patients are not offered treatment with CPI as it is generally assumed that steroid treatment hamper their clinical efficacy Thus this group of patients face a large unmet need
Due to the immune inhibiting effects steroids are used to manage immune-related adverse events irAEs induced by CPI treatment However patients receiving steroids in this context are still able to achieve and maintain clinical benefit even after stopping treatment
It is not known whether steroid treatment at the time of initiation of CPI treatment diminishes the treatment effect as patients in need of steroid treatment are generally excluded from clinical trials
Patients enrolled in pivotal clinical trials for immunotherapy of MM are highly selected and does not include patients with brain metastases Small phase II studies lend support to CPI to yield responses in melanoma that has metastasized to the brain However a large proportion of patients that develop brain metastasis will require continued systemic treatment with steroids to alleviate symptoms from the central nervous system CNS This group of patients are not offered treatment with CPI as it is generally assumed that steroid treatment hamper their clinical efficacy Thus this group of patients face a large unmet need
Due to the immune inhibiting effects steroids are used to manage immune-related adverse events irAEs induced by CPI treatment However patients receiving steroids in this context are still able to achieve and maintain clinical benefit even after stopping treatment
It is not known whether steroid treatment at the time of initiation of CPI treatment diminishes the treatment effect as patients in need of steroid treatment are generally excluded from clinical trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None