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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Ipilimumab

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Prostate cancer with metastases
Prostate cancer should be castration resistant
Progression during hormonal therapy

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1: Ipilimumab 3 mg/kg

Arm 2: Ipilimumab 10 mg/kg

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02279862

First Posted

October 29, 2014

Last Updated

August 14, 2019

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02279862

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

December 2, 2014 (Actual)

Primary Completion Date

December 15, 2016 (Actual)

Study Completion Date

December 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

Detailed Description

Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Response Evaluation Criteria In Solid Tumors (RECIST)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Ipilimumab 3 mg/kg

Arm Type

Experimental

Arm Description

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

Arm Title

Arm 2: Ipilimumab 10 mg/kg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ipilimumab

Other Intervention Name(s)

Yervoy™

Primary Outcome Measure Information:

Title

Radiographic Progression-free Survival (rPFS)

Description

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.

Time Frame

From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)

Secondary Outcome Measure Information:

Title

Number of Participants Who Experienced Immune-related Adverse Events (irAEs)

Description

The total number of participants with immune-related adverse events of any grade is reported for each arm.

Time Frame

From first dose of ipilimumab to last dose plus 90 days

Title

Overall Survival (OS)

Description

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.

Time Frame

From randomization to death from any cause (assessed up to December 2016, approximately 24 months)

Title

Prostate Specific Antigen Progression-free Survival (PSA PFS)

Description

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.

Time Frame

From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months)

Title

Time to Pain Progression

Description

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.

Time Frame

From randomization until pain progression (assessed up to December 2016, approximately 24 months)

Title

Prostate Specific Antigen Response Rate

Description

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.

Time Frame

From baseline to PSA response (assessed up to December 2016, approximately 48 months)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Prostate cancer with metastases Prostate cancer should be castration resistant Progression during hormonal therapy Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

San Francisco Oncology Associates

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

George Washington University Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Baptist Cancer Institute

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Cancer Center Of Kansas

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

North Mississippi Med Center

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Nebraska Cancer Specialists

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Providence Portland Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Northwest Cancer Specialists, Pc

City

Tualatin

State/Province

Oregon

ZIP/Postal Code

97062

Country

United States

Facility Name

University of Pittsburgh Cancer Institute Cancer Services

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232-1305

Country

United States

Facility Name

Texas Oncology

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Virginia Cancer Institute

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

Local Institution

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Local Institution

City

Wahroonga

State/Province

New South Wales

ZIP/Postal Code

2076

Country

Australia

Facility Name

Local Institution

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Local Institution

City

Santiago

State/Province

Metropolitana

Country

Chile

Facility Name

Local Institution

City

Recoleta

State/Province

Santiago DE Chile

Country

Chile

Facility Name

Local Institution

City

Vina Del Mar

State/Province

Valparaiso

ZIP/Postal Code

2540364

Country

Chile

Facility Name

Local Institution

City

Clermont Ferrand cedex 01

ZIP/Postal Code

63011

Country

France

Facility Name

Local Institution

City

Marseille Cedex 9

ZIP/Postal Code

13273

Country

France

Facility Name

Local Institution

City

Poitiers

Country

France

Facility Name

Local Institution

City

Rennes Cedex

ZIP/Postal Code

35042

Country

France

Facility Name

Local Institution

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Local Institution

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Universitaetsklinikum Aachen

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Uniklinik Heidelberg

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Universitaetsklinikum Jena

City

Jena

ZIP/Postal Code

07743

Country

Germany

Facility Name

Universitaetsklinikum Magdeburg

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Universitaetsklinikum Mannheim

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Local Institution

City

Marktredwitz

ZIP/Postal Code

95615

Country

Germany

Facility Name

Klinikum rechts der Isar der TU

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Urologische Praxis

City

Rostock

ZIP/Postal Code

18107

Country

Germany

Facility Name

Urologische Gemeinschaftspraxis Dres Stammel U. Garcia

City

Wesel

ZIP/Postal Code

46483

Country

Germany

Facility Name

Dgu Urologie

City

Wuppertal

ZIP/Postal Code

42103

Country

Germany

Facility Name

Local Institution

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Istituto Nazionale Tumori Fondazione Pascale

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Local Institution

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution

City

Hospitalet de Llobregat - Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Local Institution

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Local Institution

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Local Institution

City

Glasgow

State/Province

Lanarkshire

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Local Institution

City

Nottingham

State/Province

Nottinghamshire

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Local Institution

City

Guildford

State/Province

Surrey

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://bms.com/studyconnect/Pages/home.aspx

Description

BMS Clinical Trial Patient Recruiting

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial