Trials / Completed
CompletedNCT04040231
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Galinpepimut-S | 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. |
| DRUG | Nivolumab | Participants will receive nivolumab and the galinpepimut-S vaccine over 16 weeks in the initial treatment phase. |
| BIOLOGICAL | Sargramostim | All participants will receive Sargramostim (GM-CSF) 70 mcg injected subcutaneously on days 0 and -2 of each cycle |
Timeline
- Start date
- 2019-07-24
- Primary completion
- 2024-11-14
- Completion
- 2024-11-14
- First posted
- 2019-07-31
- Last updated
- 2025-05-13
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04040231. Inclusion in this directory is not an endorsement.