Prostate CancerPhase 2NCT02279862
Safety and Efficacy Study of Ipilimumab 3 mg/kg Versus Ipilimumab 10 mg/kg in Subjects With Metastatic Castration Resistant Prostate Cancer Who Are Chemotherapy Naive
A Phase 2 study testing Ipilimumab in people with Prostate Cancer, run by Bristol-Myers Squibb at 43 sites in 9 countries.
Trial summary
The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant 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
- What is being tested?
- Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 43 sitesin 9 countries
- Study dates
- 2 Dec 2014to 15 Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Prostate cancer with metastases
- Prostate cancer should be castration resistant
- Progression during hormonal therapy
Who cannot join
- Visceral metastases (eg liver, lung or brain metastases)
- Prior treatment with any immunotherapy for prostate cancer
- Prior or ongoing cytotoxic therapy for prostate cancer
- Autoimmune disease
- Inadequate hematologic, renal, or hepatic function
Trial locations and contacts
43 sites in 9 countries.
43 sites in 9 countries
United States11 sites
Texas Oncology
Houston, Texas, 77024
Baptist Cancer Institute
Jacksonville, Florida, 32207
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, 15232-1305
Providence Portland Medical Center
Portland, Oregon, 97213
Virginia Cancer Institute
Richmond, Virginia, 23230
San Francisco Oncology Associates
San Francisco, California, 94115
Northwest Cancer Specialists, Pc
Tualatin, Oregon, 97062
North Mississippi Med Center
Tupelo, Mississippi, 38801
George Washington University Medical Center
Washington D.C., District of Columbia, 20037
Cancer Center Of Kansas
Wichita, Kansas, 67214
Germany10 sites
Universitaetsklinikum Aachen
Aachen, 52074
Uniklinik Heidelberg
Heidelberg, 69120
Universitaetsklinikum Jena
Jena, 07743
Universitaetsklinikum Magdeburg
Magdeburg, 39120
Universitaetsklinikum Mannheim
Mannheim, 68167
Local Institution
Marktredwitz, 95615
Klinikum rechts der Isar der TU
München, 81675
Urologische Praxis
Rostock, 18107
Urologische Gemeinschaftspraxis Dres Stammel U. Garcia
Wesel, 46483
Dgu Urologie
Wuppertal, 42103
France6 sites
Local Institution
Clermont-Ferrand, 63011
Local Institution
Marseille, 13273
Local Institution
Poitiers
Local Institution
Rennes, 35042
Local Institution
Saint-Herblain, 44805
Local Institution
Villejuif, 94805
Spain4 sites
Local Institution
Barcelona, 08035
Local Institution
Hospitalet de Llobregat - Barcelona, 08908
Local Institution
Seville, 41009
Local Institution
Valencia, 46009
Australia3 sites
Local Institution
Parkville, Victoria, 3050
Local Institution
St Leonards, New South Wales, 2065
Local Institution
Wahroonga, New South Wales, 2076
Chile3 sites
Local Institution
Recoleta, Santiago de Chile
Local Institution
Santiago, Santiago Metropolitan
Local Institution
Viña del Mar, Valparaiso, 2540364
United Kingdom3 sites
Local Institution
Glasgow, Lanarkshire, G12 0YN
Local Institution
Guildford, Surrey, GU2 7XX
Local Institution
Nottingham, Nottinghamshire, NG5 1PB
Italy2 sites
Local Institution
Milan, 20133
Istituto Nazionale Tumori Fondazione Pascale
Naples, 80131
About this study
Official title: A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic
The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.
Read the detailed description
Prostate Cancer Clinical Trials Working Group 2 (PCWG2)
Response Evaluation Criteria In Solid Tumors (RECIST)
- Conditions
- Prostate Cancer
- Being tested
- 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.
IpilimumabDrug
Also called Yervoy™
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Ipilimumab 3 mg/kg | Experimental | Ipilimumab 3 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose Receives: Drug: Ipilimumab |
| Arm 2: Ipilimumab 10 mg/kg | Experimental | Ipilimumab 10 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose Receives: Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression-free Survival (rPFS)
rPFS was defined as the time from the date of randomization until the date of disease progression based on radiographic evidence and/or death from any cause, whichever occurs first. Radiographic disease progression is defined as: Confirmed bone disease progression according to criteria adapted from the Prostate Cancer Clinical Trials Working Group 2 (PCWG2), OR Non-bone disease progression according to the modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported radiographic progression is shown.
Measured: From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)
Secondary outcomes (5)
Number of Participants Who Experienced Immune-related Adverse Events (irAEs)
The total number of participants with immune-related adverse events of any grade is reported for each arm.
Measured: From first dose of ipilimumab to last dose plus 90 days
Overall Survival (OS)
OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored at the last date the participant was known to be alive. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The total number of reported deaths is shown.
Measured: From randomization to death from any cause (assessed up to December 2016, approximately 24 months)
Prostate Specific Antigen Progression-free Survival (PSA PFS)
Prostate specific antigen progression-free survival (PSA PFS) was defined as the time from randomization to the earliest date of PSA progression or death, whichever occurs earlier. Participants who did not progress or die were censored at the last PSA assessment date. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported PSA progression is shown.
Measured: From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months)
Time to Pain Progression
Pain progression was defined as an increase in BPI-SF pain Item #3 score of >= 2 point from baseline maintained over 2 consecutive periods. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment, and presented efficacy results are based on limited data. The number of participants with reported pain progression is shown.
Measured: From randomization until pain progression (assessed up to December 2016, approximately 24 months)
Prostate Specific Antigen Response Rate
PSA response rate was defined as the proportion of participants with a 50% or greater decrease from baseline to the lowest post-baseline PSA result (confirmed 3 weeks later) for each randomized arm. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants showing PSA response is shown.
Measured: From baseline to PSA response (assessed up to December 2016, approximately 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start2 Dec 2014
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279862
- Sponsor's protocol ID
- CA184-437
- Other IDs
- 2014-002987-34, 2014
- Status last verified
- Aug 2019
- First submitted
- 29 Oct 2014
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who Are Asymptomatic or Minimally Symptomatic
- ClinicalTrials.gov ID
- NCT02279862
- Acronym / sponsor ID
- CA184-437
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2014 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 19 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.
Detailed description
Prostate Cancer Clinical Trials Working Group 2 (PCWG2)
Response Evaluation Criteria In Solid Tumors (RECIST)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Ipilimumab 3 mg/kg | Experimental | Drug: IpilimumabIpilimumab 3 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose |
| Arm 2: Ipilimumab 10 mg/kg | Experimental | Drug: IpilimumabIpilimumab 10 mg/kg injection intravenously every 3 weeks for 4 doses in Induction phase. Subjects that are eligible to receive Ipilimumab in the Maintenance phase will be dosed every 12 weeks for a maximum of 3 years since the first induction dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prostate cancer with metastases
- Prostate cancer should be castration resistant
- Progression during hormonal therapy
Key exclusion criteria (5 listed)
- Visceral metastases (eg liver, lung or brain metastases)
- Prior treatment with any immunotherapy for prostate cancer
- Prior or ongoing cytotoxic therapy for prostate cancer
- Autoimmune disease
- Inadequate hematologic, renal, or hepatic function
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 |
|---|---|---|
| IpilimumabAlso: Yervoy™ | Drug | Arm 1: Ipilimumab 3 mg/kg, Arm 2: Ipilimumab 10 mg/kg |
Primary outcome
Radiographic Progression-free Survival (rPFS)
Time frame: From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)
rPFS was defined as the time from the date of randomization until the date of disease progression based on radiographic evidence and/or death from any cause, whichever occurs first. Radiographic disease progression is defined as: Confirmed bone disease progression according to criteria adapted from the Prostate Cancer Clinical Trials Working Group 2 (PCWG2), OR Non-bone disease progression according to the modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported radiographic progression is shown.
5 secondary outcomes
Number of Participants Who Experienced Immune-related Adverse Events (irAEs)
Time frame: From first dose of ipilimumab to last dose plus 90 days
Overall Survival (OS)
Time frame: From randomization to death from any cause (assessed up to December 2016, approximately 24 months)
Prostate Specific Antigen Progression-free Survival (PSA PFS)
Time frame: From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months)
Time to Pain Progression
Time frame: From randomization until pain progression (assessed up to December 2016, approximately 24 months)
Prostate Specific Antigen Response Rate
Time frame: From baseline to PSA response (assessed up to December 2016, approximately 48 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
43 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab in people with Prostate Cancer, run by Bristol-Myers Squibb at 43 sites in 9 countries.
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 3 inclusion and 5 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany, France, Spain, Australia and 4 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Radiographic Progression-free Survival (rPFS) (time frame: From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)). 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 28 Aug 2019.