At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 50 enrolled

Drug / intervention

SipT Treatment +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01804465

NCT01804465Phase 2Completed

Compare CT.gov

A Randomized Phase 2 Trial of Immediate vs. Delayed Anti-CTLA4 Blockade Following Sipuleucel-T Treatment for Prostate Cancer Immunotherapy

University of California, San Francisco·interventional·Posted Mar 5, 2013·Updated Aug 18, 2021

In Brief

A Phase 2 clinical trial evaluating SipT Treatment and Ipilimumab for Prostate Cancer. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

The purpose of this study is to find out what effects taking ipilimumab, as an immediate or delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and their prostate cancer.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsProstate Cancer

CountriesUnited States

CollaboratorsM.D. Anderson Cancer Center, Bristol-Myers Squibb, Dendreon

Timeline

Phase 2CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedMar 2013

Enrollment StartApr 2014

Primary CompletionFeb 2020

Study CompletionAug 2020

TodayJul 2026

First PostedMar 5, 2013

Enrollment StartApr 22, 2014

Primary CompletionFeb 27, 2020

Study CompletionAug 31, 2020

TodayJul 2, 2026

Enrollment to primary: 5.8 yearsPosted 13.3 years ago

Interventions

SipT Treatmentdrug

All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete. SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion.

Ipilimumabdrug

Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.