Prostate Cancer Clinical Trial

A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)

Summary

The purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mCRPC).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI).
Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone (GnRH) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/L (50ng/dL)

For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma of the prostate and evidence of Stage IV disease (as defined by American Joint Committee of Cancer criteria (AJCC criteria) prior to randomization

Exclusion Criteria:

Presence of visceral metastases in the liver
Active brain metastases or leptomeningeal metastases
Active, known, or suspected autoimmune disease or infection
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

Prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab
Have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel)

Other protocol-defined inclusion/exclusion criteria apply

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

340

Study ID:

NCT02985957

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 60 Locations for this study

See Locations Near You

Local Institution - 0074
Tucson Arizona, 85711, United States
Local Institution - 0046
Marietta Georgia, 30060, United States
Local Institution - 0011
Chicago Illinois, 60637, United States
Local Institution - 0076
Minneapolis Minnesota, 55404, United States
Local Institution - 0008
Saint Louis Missouri, 63110, United States
Local Institution - 0075
Las Vegas Nevada, 89169, United States
Local Institution - 0078
Albany New York, 12208, United States
Local Institution - 0065
Lake Success New York, 11042, United States
Local Institution - 0001
New York New York, 10029, United States
Local Institution - 0077
Tigard Oregon, 97223, United States
Local Institution - 0047
Allentown Pennsylvania, 18103, United States
Local Institution - 0010
Philadelphia Pennsylvania, 19104, United States
Local Institution - 0067
Charleston South Carolina, 29425, United States
Local Institution - 0079
Austin Texas, 78731, United States
Local Institution - 0002
Houston Texas, 77030, United States
Local Institution - 0027
Gosford New South Wales, 2250, Australia
Local Institution - 0059
Wahroonga New South Wales, 2076, Australia
Local Institution - 0029
Westmead New South Wales, 2145, Australia
Local Institution - 0028
Southport Queensland, 4215, Australia
Local Institution - 0043
Woolloongabba Queensland, 4012, Australia
Local Institution - 0030
Elizabeth Vale South Australia, 5112, Australia
Local Institution - 0031
Clayton Victoria, 3168, Australia
Local Institution - 0048
Wien , 1090, Austria
Local Institution
Montreal Quebec, H1T 2, Canada
Local Institution - 0044
Montreal Quebec, H2X 0, Canada
Local Institution - 0062
Aalborg , 9000, Denmark
Local Institution - 0063
Aarhus N , 8200, Denmark
Local Institution - 0061
Kobenhavn O , 2100, Denmark
Local Institution - 0060
Odense , 5000, Denmark
Local Institution - 0009
Clermont-ferrand , 63000, France
Local Institution - 0005
Lyon , 69008, France
Local Institution - 0004
Marseille Cedex 9 , 13273, France
Local Institution - 0003
Villejuif , 94805, France
Local Institution - 0041
Braunschweig , 38114, Germany
Local Institution - 0032
Dresden , 01307, Germany
Local Institution - 0038
Goettingen , 37075, Germany
Local Institution - 0019
Herne , 44625, Germany
Local Institution - 0017
Jena , 07747, Germany
Local Institution - 0018
Muenster , 48149, Germany
Local Institution - 0034
Munich , 81377, Germany
Local Institution - 0037
Nuernberg , 90419, Germany
Local Institution - 0042
Nuertingen , 72622, Germany
Local Institution - 0036
Rostock , 18107, Germany
Local Institution - 0033
Tuebingen , 72076, Germany
Local Institution - 0035
Wesel , 46483, Germany
Local Institution - 0071
Arezzo , 52100, Italy
Local Institution - 0052
Milano , 20133, Italy
Local Institution - 0053
Napoli , 80131, Italy
Local Institution - 0072
Parma , 43100, Italy
Local Institution - 0051
Terni , 05100, Italy
Local Institution - 0055
Kraków Małopolskie, 30-68, Poland
Local Institution - 0066
Koszalin , 75-58, Poland
Local Institution - 0054
Warszawa , 02-78, Poland
Local Institution - 0026
Badajoz , 06080, Spain
Local Institution - 0025
Barcelona , 08003, Spain
Local Institution - 0020
Madrid , 28007, Spain
Local Institution - 0022
Madrid , 28027, Spain
Local Institution - 0021
Madrid , 28041, Spain
Local Institution - 0024
Malaga , 29010, Spain
Local Institution - 0023
Santiago Compostela , 15706, Spain

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

340

Study ID:

NCT02985957

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.