This phase I trial studies the side effects of a vaccine, galinpepimut-S, and nivolumab in treating patients with WT1 positive malignant pleural mesothelioma. Vaccines, such as galinpepimut-S, are made from Wilms Tumor Protein 1 (WT1) peptide and may help the body build an effective immune response to kill tumor cells that express WT1. Galinpepimut-S is mixed with a substance called montanide, which helps to boost the immune reaction to galinpepimut-S. The mixture of the galinpepimut-S and montanide make up the actual final vaccine that is then given to patients. Immunotherapy with monoclonal antibodies, such as nivolumab, may remove signals that block the immune system’s activity, indirectly strengthening the immune system to help fight the cancer. It has been shown that cancer vaccines can sometimes increase these signals that actually block the immune system’s anti-cancer activity. Using a cancer vaccine (galinpepimut-S) directed to mesothelioma cells with a drug that can unblock these negative signals (nivolumab) may help treat malignant pleural mesothelioma.
Additional locations may be listed on ClinicalTrials.gov for NCT04040231.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the tolerability of galinpepimut-S combined with nivolumab in patients with previously treated malignant pleural mesothelioma (MPM).
SECONDARY OBJECTIVE:
I. To evaluate the immunogenicity of galinpepimut-S combined with nivolumab in patients with previously treated MPM by assessing the Wilms tumor (WT)1-specific cell-mediated immune response both peripherally and at the tumor site.
OUTLINE:
Patients receive sargramostim subcutaneously (SC) on days -2 and 0 of weeks 0, 2, 4, 6, 8, 10, 12, and 14. Patients galinpepimut-S mixed with montanide ISA 51 (montanide) VG SC on day 0 of weeks 0, 2, 4, 6, 8, 10, 12, and 14, and nivolumab intravenously (IV) over 30 minutes on weeks 4, 6, 8, 10, 12, and 14 in the absence of disease progression or unacceptable toxicity. Patients who do not have progressive disease at the end of 16 weeks receive galinpepimut-S mixed with montanide SC and nivolumab IV over 30 minutes starting at week 20. Treatment repeats every 2 weeks for up to 6 additional treatments (12 weeks) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo tumor biopsy, blood sample collection and computed tomography (CT) on study.
After completion of study treatment, patients are followed up every 3 months for up to 1 year.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMichael David Offin
