Prostate CancerPhase 1NCT01832870
Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer
A Phase 1 study testing sipuleucel-T and ipilimumab in people with Prostate Cancer and Castrate Resistant Prostate Cancer, run by Prostate Oncology Specialists, Inc. at 1 site in United States.
Trial summary
This is a clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Castrate Resistant Prostate Cancer
- What is being tested?
- sipuleucel-T and ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Feb 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with advanced prostate cancer who are eligible to receive sipuleucel-T in accordance with FDA approved labeling of sipuleucel-T
- Subjects must understand and sign an informed consent form
Who cannot join
- Subjects who are not eligible to receive sipuleucel-T
Trial locations and contacts
1 site in 1 country.
United States1 site
Prostate Oncology Specialists, Inc.
Marina del Rey, California, 90292
About this study
Official title: Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer
This is a clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer.
- Being tested
- sipuleucel-T, ipilimumab
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sipuleucel-TDrug
Also called Provenge
ipilimumabDrug
Also called Yervoy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab. Receives: Drug: sipuleucel-T; Drug: ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antigen-specific memory T cell response
To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination.
Measured: After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
Antigen-specific T cell proliferation to PA2024, PAP and PHA
To quantify Antigen-specific T cell proliferation to PA2024, PAP and PHA when sipuleucel-T and ipilimumab are given in combination.
- PA2024 is a recombinant protein
- PAP: Prostatic acid phosphatase
- PHA: Phytohaemagglutinin, an assay control
Measured: After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
Antibody responses against PA2024 and PAP
To quantify antibody responses against PA2024 and PAP.
- PA2024 is a recombinant protein
- PAP: Prostatic acid phosphatase
Measured: After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months
Secondary outcomes (4)
Prostate-Specific Antigen (PSA) doubling time
To measure changes in PSA doubling time following treatment with sipuleucel-T and ipilimumab
Measured: Duration of the study, an expected average of 18 months
Time to PSA progression
To quantify time to PSA progression after treatment with sipuleucel-T and ipilimumab
Measured: Duration of the study, an expected average of 18 months
Time to salvage therapy
To quantify time to salvage therapy after treatment with sipuleucel-T and ipilimumab
Measured: Duration of the study, an expected average of 18 months
Percentage PSA decline
To measure percentage PSA decline following treatment with sipuleucel-T and ipilimumab
Measured: Duration of the study, an expected average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prostate Oncology Specialists, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Scholz, MD, Principal investigator, Prostate Oncology Specialists, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832870
- Sponsor's protocol ID
- SIPIPI 2013
- Status last verified
- Aug 2017
- First submitted
- 10 Apr 2013
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Sipuleucel-T and Ipilimumab in Combination for Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT01832870
- Acronym / sponsor ID
- SIPIPI 2013
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Prostate Oncology Specialists, Inc.University, hospital or other
- Study start
- Apr 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: sipuleucel-T, Drug: ipilimumabPatients enrolled will receive the standard 3-dose treatment of sipuleucel-T, followed by treatment(s) of ipilimumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with advanced prostate cancer who are eligible to receive sipuleucel-T in accordance with FDA approved labeling of sipuleucel-T
- Subjects must understand and sign an informed consent form
Key exclusion criteria (1 listed)
- Subjects who are not eligible to receive sipuleucel-T
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sipuleucel-TAlso: Provenge | Drug | Treatment |
| ipilimumabAlso: Yervoy | Drug | Treatment |
Primary outcome
Antigen-specific memory T cell response
Time frame: After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination.
Antigen-specific T cell proliferation to PA2024, PAP and PHA
Time frame: After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months
To quantify Antigen-specific T cell proliferation to PA2024, PAP and PHA when sipuleucel-T and ipilimumab are given in combination. * PA2024 is a recombinant protein * PAP: Prostatic acid phosphatase * PHA: Phytohaemagglutinin, an assay control
Antibody responses against PA2024 and PAP
Time frame: After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months
To quantify antibody responses against PA2024 and PAP. * PA2024 is a recombinant protein * PAP: Prostatic acid phosphatase
4 secondary outcomes
Prostate-Specific Antigen (PSA) doubling time
Time frame: Duration of the study, an expected average of 18 months
Time to PSA progression
Time frame: Duration of the study, an expected average of 18 months
Time to salvage therapy
Time frame: Duration of the study, an expected average of 18 months
Percentage PSA decline
Time frame: Duration of the study, an expected average of 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Scholz, MD principal investigator
Prostate Oncology Specialists, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sipuleucel-T and ipilimumab in people with Prostate Cancer and Castrate Resistant Prostate Cancer, run by Prostate Oncology Specialists, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antigen-specific memory T cell response (time frame: After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.