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NCT01804465 · ClinicalTrials.gov registry record · Phase 2

Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer

A Phase 2 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT01804465: Completed Phase 2 study, sponsored by University of California, San Francisco.

NCT01804465 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01804465, a Phase 2 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study 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.

Primary Outcome

Immune response will be tested using the single sample binomial exact test when induction therapy is completed. The Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibody responses to PAP and/or PA2024 will be assessed by ELISA assay at baseline and week 20 after start of sipT treatment (day 113 of study treatment). A positive response is defined as a titer \> 1:400. The positive immune percentage for both IgG and IgM antibodies to PAP and to PA2024 will be used to summarize the results for

Interventions

  • DRUG Ipilimumab
  • DRUG SipT Treatment

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2014-04-22
Est. Completion 2020-08-31
Phase Phase 2

What the finished NCT01804465 record still lists

NCT01804465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 2 interventions - of which Ipilimumab is the first listed.

NCT01804465 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01804465 about?

NCT01804465 is a clinical study titled "Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer". 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.

What is the current status of trial NCT01804465?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2014-04-22. Estimated completion is 2020-08-31.

What interventions are being tested in trial NCT01804465?

The interventions under investigation include: Ipilimumab (DRUG), SipT Treatment (DRUG).

Who is sponsoring clinical trial NCT01804465?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01804465's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01804465, the US trial registry maintained by the National Library of Medicine. NCT01804465 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.