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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02737787
Other study ID # 15-247
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 2016
Est. completion date April 6, 2023

Study information

Verified date April 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the safety of a combination of an investigational WT1 vaccine and another drug called nivolumab. This is the first time that the WT1 vaccine and nivolumab are being used in combination. Also, to test the safety of a combination of an investigational NY-ESO-1 vaccine and another drug called nivolumab.


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Study Design


Intervention

Biological:
WT1 Vaccine

Drug:
Nivolumab
Nivolumab will be administered intravenously as a 30-minute infusion per institutional guidelines on weeks 0, 2, 4, 6, 8, 10 and 12.
Biological:
NY-ESO-1 Vaccine
Patients will be vaccinated with the NY-ESO-1 OLP4 vaccine. Patients will receive a 1.0 mL emulsion of NY-ESO-1 OLPs with Poly-ICLC and Montanide.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack (All Protocol Activities) Commack New York
United States Memorial Sloan Kettering Westchester (All Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (All Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (All Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Memorial Sloan Kettering Nassau (All protocol activities) Rockville Centre New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose limiting toxicity (DLT) The first 3 patients will be observed for 30 days before enrolling the next 7 patients. Accrual will continue as patients become available after the first 3 patients are observed for 30 days. If >2/10 DLTs are observed then the study combination will not be considered safe. 30 days
Secondary immune response (cohort 2) Serologic IgM and IgG antibody responses will be measured by ELISA against each antigen week 15
Secondary progression-free survival rate (cohort 2) Will evaluate PFS rate at 1-year using Kaplan Meier methodology 1 year
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