Ignite Creation Date:
2024-05-06 @ 2:44 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02115139
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2014-04-10
Brief Title:
GEM STUDY Radiation And Yervoy in Patients With Melanoma and Brain Metastases
Sponsor:
Grupo Español Multidisciplinar de Melanoma
Organization:
Grupo Español Multidisciplinar de Melanoma
Study Overview
Official Title:
A Multicenter Single Arm Phase 2 Clinical Study on the Combination of Radiation Therapy and Ipilimumab for the Treatment of Patients With Melanoma and Brain Metastases
Status:
COMPLETED
Status Verified Date:
2022-10
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:
GRAY-B
Brief Summary:
Ipilimumab adds a clinical benefit to radiation therapy in patients with melanoma metastatic to the brain
Melanoma is the third most common cancer causing brain metastases after cancers of the lung and breast which appears to reflect the relative propensity of melanoma to metastasize to the central nervous system CNS Brain metastases are responsible for 20 to 54 percent of deaths in patients with melanoma and among those with documented brain metastases these lesions contribute to death in up to 95 percent of cases with an estimated median overall survival ranging between 18 and 105 months depending upon other prognostic factors
Ipilimumab is an anti-Cytotoxic T-Lymphocyte Antigen 4 anti-CTLA4 monoclonal antibody that has demonstrated a clinically relevant and statistically significant improvement in overall survival either alone second line or in combination with dacarbazine DTIC in 1st line
Ipilimumab has shown activity against brain metastases
According to the European Medicines Agency EMA approved label for Yervoy the use of glucocorticoids at baseline commonly prescribed when brain metastases are diagnosed should be avoided before the administration of ipilimumab Data show that the use of even high doses of glucocorticoids for the management of immune-related adverse events do not decrease the efficacy of Yervoy There is no documented experience on the efficacy of Yervoy when given concomitantly with radiation therapy and glucocorticoids
In experimental models radiation therapy is synergistic to anti-Cytotoxic T-Lymphocyte Antigen 4 anti-CTLA4 strategies abscopal effect
There are no published results from clinical trials on the interaction between radiation therapy and ipilimumab
Melanoma is the third most common cancer causing brain metastases after cancers of the lung and breast which appears to reflect the relative propensity of melanoma to metastasize to the central nervous system CNS Brain metastases are responsible for 20 to 54 percent of deaths in patients with melanoma and among those with documented brain metastases these lesions contribute to death in up to 95 percent of cases with an estimated median overall survival ranging between 18 and 105 months depending upon other prognostic factors
Ipilimumab is an anti-Cytotoxic T-Lymphocyte Antigen 4 anti-CTLA4 monoclonal antibody that has demonstrated a clinically relevant and statistically significant improvement in overall survival either alone second line or in combination with dacarbazine DTIC in 1st line
Ipilimumab has shown activity against brain metastases
According to the European Medicines Agency EMA approved label for Yervoy the use of glucocorticoids at baseline commonly prescribed when brain metastases are diagnosed should be avoided before the administration of ipilimumab Data show that the use of even high doses of glucocorticoids for the management of immune-related adverse events do not decrease the efficacy of Yervoy There is no documented experience on the efficacy of Yervoy when given concomitantly with radiation therapy and glucocorticoids
In experimental models radiation therapy is synergistic to anti-Cytotoxic T-Lymphocyte Antigen 4 anti-CTLA4 strategies abscopal effect
There are no published results from clinical trials on the interaction between radiation therapy and ipilimumab
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-001132-22 | EUDRACT_NUMBER | None | None |