Galinpepimut-S
BiologicalGalinpepimut-S will be administered alone on weeks 0 and 2. Participants will receive the galinpepimut-S vaccine and nivolumab over 16 weeks in the initial treatment phase.
NCT Number: NCT04040231
The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Galinpepimut-S will be administered alone on weeks 0 and 2. Participants will receive the galinpepimut-S vaccine and nivolumab over 16 weeks in the initial treatment phase.
Participants will receive nivolumab and the galinpepimut-S vaccine over 16 weeks in the initial treatment phase.
All participants will receive Sargramostim (GM-CSF) 70 mcg injected subcutaneously on days 0 and -2 of each cycle
Other names: GM-CSF
Time frame: up to 24 months
A dose will be considered tolerable if there are no more than 2 out of 10 participants with dose limiting toxicities.
Memorial Sloan Kettering Cancer Center
Other
Combining a WT1 Cancer Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Malignant Pleural Mesothelioma: A Phase I Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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