Phase 2
N=41
Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy
Malignant Pleural Mesothelioma
Bottom Line
View on ClinicalTrials.gov: NCT01265433 ↗Enrolled (actual)
41
Serious AEs
4.9%
Results posted
Oct 2024
Primary outcome: Primary: 1-year Progression-free Survival — 44; 33 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Galinpepimut-S + Montanide + GM-CSF (Biological); Montanide + GM-CSF (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sellas Life Sciences Group
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1-year Progression-free Survival |
44; 33 | — |
| PRIMARY Progression-free Survival |
10.1; 7.4 | — |
| SECONDARY Overall Survival |
22.8; 18.3 | — |
| SECONDARY Immune Response |
4; 1; 4; 8; 2; 3 | — |
Summary
Study of galinpepimut-S, a Wilms Tumor-1 (WT1) vaccine, to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates gene expression and causes cell growth.
Eligibility Criteria
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/decortication or extrapleural pneumonectomy. The surgery should be performed with the intent of complete resection, though patients with an R1 resection will still be eligible. Patients should have also received treatment with chemotherapy and/or radiation. Patients with an R2 resection are also eligible as long as the site of residual disease is treated post-operatively with radiotherapy.
- 4-12 weeks since completion of combined modality therapy.
- Age > or = to 18 years
- Karnofsky performance status > or = to 70%
- Hematologic parameters: Absolute neutrophil count > or = to 1000/mcL, Platelets > or = to 50K/mcL.
- Biochemical parameters: Total bilirubin < or = to 2.0 mg/dl, AST and ALT < or = to 2.5 x upper limits of normal, Creatinine < or = to 2.0 mg/dl.
Exclusion Criteria
- Pregnant or lactating women.
- Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments.
- Patients with a serious unstable medical illness or another active cancer.
- Patients taking systemic corticosteroids.
- Patients with an immunodeficiency syndrome.
Data sourced from ClinicalTrials.gov (NCT01265433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.