Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGalinpepimut-S + Montanide + GM-CSF and Montanide + GM-CSF

The study team can explain what participation involves.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 9, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Sellas Life Sciences Group

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Sellas Life Sciences Group
Interventions being studied: Biological: Galinpepimut-S + Montanide + GM-CSF; Biological: Montanide + GM-CSF

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Mesothelioma→

Treatment approach

Surgery→

Study topics

After surgery (adjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Memorial Sloan Kettering Cancer CenterNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 9, 2024. Always confirm current availability with the study team.

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