Clinical trial · Interventional
Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma
Combining a WT1 Cancer Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Malignant Pleural Mesothelioma: A Phase I Study
NCT04040231CI-TRIAL-00089564completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Pleural Mesothelioma | Pleural Mesothelial Neoplasm | ALIAS | 0.90 |
| Wilms Tumor | Wilms Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Galinpepimut-S | Biological | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Malignant Pleural Mesothelioma (MPM)
- description
- Participants with previously treated Malignant Pleural Mesothelioma/MPM
- interventionNames
- Biological: Galinpepimut-S
- Drug: Nivolumab
- Biological: Sargramostim
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- up to 24 months
- description
- A dose will be considered tolerable if there are no more than 2 out of 10 participants with dose limiting toxicities.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>/= 18 years * Karnofsky performance status \>/= 70% * Pathologic diagnosis of malignant pleural mesothelioma at MSK * Positive immunohistochemical staining for WT-1 within 60 days of treatment start * Patients must have received at least one prior course of pemetrexed-based chemotherapy * Patients of childbearing potential must have a negative serum pregnancy test within 24 hours of receiving the first treatment on the study (if female) and must be practicing an effective form of birth control for the entire duration of treatment (both females and males) * Has received and progressed or are refractory to pemetrexed based chemotherapy * Measurable or evaluable disease * Biochemical parameters: Total bilirubin \< 1.5 mg/dl, AST and ALT \< 3.0 x upper limits of normal, Creatinine \< 1.5 x upper limits of normal Exclusion Criteria: * Pregnant or lactating women * Prior receipt of checkpoint inhibition * Patients with known active hepatitis B or known active hepatitis C virus * Patients with a serious unstable medical illness or another active cancer * Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Autoimmune disease requiring treatment with systemic steroids in the past 2 years * Current use of systemic corticosteroids at doses greater than prednisone 10 mg daily or the equivalent * Patients with active pneumonitis * Hematologic parameters: Absolute neutrophil count \>/= 1000/mcL * Platelet count \<100,000
References
Publications (0)
Data not yet available
No reference posted for this study.