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Also known as Galinpepimut-S
Galinpepimut-S+ Montanide+ GM-CSF · 1 trial · 1 indication
Progression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.
Median progression free survival (PFS) is where PFS are assessed from the time of randomization to first evidence of disease recurrence or death of any cause.
| Arm | Type | Description |
|---|---|---|
| Galinpepimut-S + Montanide + GM-CSF | EXPERIMENTAL | Galinpepimut-S emulsified with Montanide adjuvant (1:1 ratio) 1 mL and GM-CSF 70 mcg |
| Montanide + GM-CSF | PLACEBO_COMPARATOR | Montanide adjuvant 1 mL and GM-CSF 70 mcg |
| Name | Type | Description |
|---|---|---|
| Galinpepimut-S + Montanide + GM-CSF | BIOLOGICAL | Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self administered) subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. |
| Montanide + GM-CSF | BIOLOGICAL | Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self-administered)subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. |
Inclusion Criteria: * Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at participating institution. * Positive immunohistochemical staining for WT-1 (greater than 10% of cells). * Completion of multimodality therapy. This must include surgical resection by either pleurectomy/...
Galinpepimut-S is an investigational cancer immunotherapy being studied for multiple myeloma, acute myelogenous leukemia, acute myeloid leukemia, and malignant pleural mesothelioma. It is being evaluated as a maintenance treatment in acute myeloid leukemia and in other oncology settings.
Galinpepimut-S is a WT1 (Wilms tumor 1) analog peptide vaccine. It is designed to stimulate the immune system to target cells expressing the WT1 antigen, which is overexpressed in several cancers including leukemia and mesothelioma.
Galinpepimut-S is being developed by SELLAS Life Sciences Group, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol SLS.
Galinpepimut-S is in Phase 3 clinical development for acute myeloid leukemia. It has also completed Phase 1 and Phase 2 trials in multiple myeloma, acute lymphoblastic leukemia, and malignant pleural mesothelioma. It is investigational and not yet approved by the FDA.
Galinpepimut-S is being studied in the Phase 3 trial NCT04229979 for acute myeloid leukemia maintenance, which is active but not recruiting. Completed trials include NCT01265433 in malignant pleural mesothelioma, NCT01266083 in acute myeloid leukemia and acute lymphoblastic leukemia, and NCT01827137 in multiple myeloma.
Yes, Galinpepimut-S is also known as a WT1 analog peptide vaccine. It is designed to target the WT1 antigen, and some clinical trial titles refer to it as the WT1 vaccine.