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

NCT02279862 | Completed Phase 2 Results

• 2 other identifiers: CA184-4372014-002987-34
• Study Type: interventional
• Target: 82
• Locations: 9 countries
• Sites: 43

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  From first dose of ipilimumab to last dose plus 90 days

• Overall Survival (OS)

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

• Prostate Specific Antigen Progression-free Survival (PSA PFS)

  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

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

• Prostate Specific Antigen Response Rate

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

Study Arms (2)

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

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

Drug: Ipilimumab

Interventions

Ipilimumab DRUG

Also known as: Yervoy™

Arm 1: Ipilimumab 3 mg/kg; Arm 2: Ipilimumab 10 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (43)

San Francisco Oncology Associates

San Francisco, California, 94115, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Cancer Center Of Kansas

Wichita, Kansas, 67214, United States

Location

North Mississippi Med Center

Tupelo, Mississippi, 38801, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Northwest Cancer Specialists, Pc

Tualatin, Oregon, 97062, United States

Location

University of Pittsburgh Cancer Institute Cancer Services

Pittsburgh, Pennsylvania, 15232-1305, United States

Location

Texas Oncology

Houston, Texas, 77024, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

Local Institution

St Leonards, New South Wales, 2065, Australia

Location

Local Institution

Wahroonga, New South Wales, 2076, Australia

Location

Local Institution

Parkville, Victoria, 3050, Australia

Location

Local Institution

Viña del Mar, Región de Valparaíso, 2540364, Chile

Location

Local Institution

Recoleta, Santiago de Chile, Chile

Location

Local Institution

Santiago, Santiago Metropolitan, Chile

Location

Local Institution

Clermont-Ferrand, 63011, France

Location

Local Institution

Marseille, 13273, France

Location

Local Institution

Poitiers, France

Location

Local Institution

Rennes, 35042, France

Location

Local Institution

Saint-Herblain, 44805, France

Location

Local Institution

Villejuif, 94805, France

Location

Universitaetsklinikum Aachen

Aachen, 52074, Germany

Location

Uniklinik Heidelberg

Heidelberg, 69120, Germany

Location

Universitaetsklinikum Jena

Jena, 07743, Germany

Location

Universitaetsklinikum Magdeburg

Magdeburg, 39120, Germany

Location

Universitaetsklinikum Mannheim

Mannheim, 68167, Germany

Location

Local Institution

Marktredwitz, 95615, Germany

Location

Klinikum rechts der Isar der TU

München, 81675, Germany

Location

Urologische Praxis

Rostock, 18107, Germany

Location

Urologische Gemeinschaftspraxis Dres Stammel U. Garcia

Wesel, 46483, Germany

Location

Dgu Urologie

Wuppertal, 42103, Germany

Location

Local Institution

Milan, 20133, Italy

Location

Istituto Nazionale Tumori Fondazione Pascale

Napoli, 80131, Italy

Location

Local Institution

Amsterdam, 1081 HV, Netherlands

Location

Local Institution

Barcelona, 08035, Spain

Location

Local Institution

Hospitalet de Llobregat - Barcelona, 08908, Spain

Location

Local Institution

Seville, 41009, Spain

Location

Local Institution

Valencia, 46009, Spain

Location

Local Institution

Glasgow, Lanarkshire, G12 0YN, United Kingdom

Location

Local Institution

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Local Institution

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Related Links

• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

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

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: December 2, 2014
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: August 28, 2019
• Results First Posted: July 19, 2018

Record last verified: 2019-08

Locations

US (11); IT (2); NL (1); AU (3); FR (6); ES (4); CL (3); DE (10); GB (3)