A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer
Launched by CELGENE · Jan 2, 2025
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment called BMS-986365 for men with metastatic castration-resistant prostate cancer, which means their cancer has spread beyond the prostate and is no longer responding to standard hormone therapies. The goal is to see how well BMS-986365 works compared to other treatments that doctors might choose for their patients. The study is currently recruiting participants aged 65 to 74 who have been diagnosed with this type of cancer and have had some previous treatments.
To participate, men must have proof of their cancer spread through imaging tests and should be experiencing little to no pain from their cancer. They should also have already tried certain hormone therapies. However, those with serious heart problems or cancer that has spread to the brain or liver are not eligible. Participants will receive care and monitoring throughout the trial to ensure their safety and to collect information about how well the treatments work. This study aims to find better options for men facing this challenging condition.
Gender
MALE
Eligibility criteria
- • Inclusion Criteria
- • Participants must have histologic or cytologic confirmation of adenocarcinoma of the prostate without small cell or neuro-endocrine features.
- • Participants must have current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography/magnetic resonance imaging (CT/MRI).
- • Participants must be asymptomatic or mildly symptomatic from prostate cancer with score on Brief Pain Inventory - Short Form (BPI-SF) that must be \< 4.
- • Participants must have had previous treatment with an androgen receptor pathway inhibitor (abiraterone, enzalutamide, apalutamide, or darolutamide).
- • Exclusion Criteria
- • Participants must not have impaired cardiac function or clinically significant cardiac disease.
- • Participants must not have any brain metastasis.
- • Participants must not have any liver metastasis.
- • Participants with superscan on technetium-99m (Tc-99m) radionuclide bone scans.
- • Other protocol-defined Inclusion/Exclusion criteria apply.
About Celgene
Celgene, now a part of Bristol Myers Squibb, is a global biopharmaceutical company dedicated to advancing innovative therapies for patients with cancer and other serious diseases. With a strong emphasis on research and development, Celgene focuses on discovering and delivering transformative medicines that address unmet medical needs. The company is committed to enhancing patient outcomes through rigorous clinical trials, cutting-edge science, and collaboration with healthcare professionals, ultimately striving to improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Adelaide, South Australia, Australia
New York, New York, United States
Madrid, , Spain
Madrid, , Spain
Portland, Oregon, United States
Portland, Oregon, United States
Washington, District Of Columbia, United States
Baltimore, Maryland, United States
Houston, Texas, United States
New York, New York, United States
San Francisco, California, United States
Madrid, , Spain
Melbourne, Victoria, Australia
Murray, Utah, United States
London, , United Kingdom
Uppsala, , Sweden
Vancouver, Washington, United States
Essen, , Germany
Wuerzburg, , Germany
Denver, Colorado, United States
Heidelberg, Victoria, Australia
Taipei, , Taiwan
Madrid, , Spain
Cordoba, , Spain
Elizabeth Vale, South Australia, Australia
Darlinghurst, New South Wales, Australia
Nashville, Tennessee, United States
Sevilla, , Spain
Athens, Georgia, United States
Sevilla, , Spain
Hamburg, , Germany
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Brno, , Czechia
Melbourne, Victoria, Australia
Praha, , Czechia
Barcelona, , Spain
Manchester, , United Kingdom
Seoul, , Korea, Republic Of
Lübeck, Schleswig Holstein, Germany
Herne, , Germany
Jena, , Germany
Wahroonga, New South Wales, Australia
Hradec Kralove, , Czechia
Goyang Si, , Korea, Republic Of
Taipei, , Taiwan
Seongnam, , Korea, Republic Of
Pierre Bénite, , France
Wien, , Austria
Madrid, , Spain
Majadahonda, , Spain
Gilbert, Arizona, United States
Burgos, , Spain
Myrtle Beach, South Carolina, United States
Badajoz, , Spain
Murdoch, Western Australia, Australia
Albuquerque, New Mexico, United States
La Jolla, California, United States
Charlottesville, Virginia, United States
Jena, Thüringen, Germany
Southport, Queensland, Australia
Solna, , Sweden
Olomouc, , Czechia
Napoli, , Italy
Ourense, , Spain
Gothenburg, , Sweden
New York, New York, United States
Sabadell, , Spain
Macquarie University, New South Wales, Australia
Vancouver, British Columbia, Canada
Terni, , Italy
Wichita, Kansas, United States
Tübingen, , Germany
Linz, , Austria
Houston, Texas, United States
Dublin, , Ireland
Los Alamitos, California, United States
Granada, , Spain
Linz, Oberösterreich, Austria
Dublin, , Ireland
Syracuse, New York, United States
Craiova, Dolj, Romania
Aarhus, Midtjylland, Denmark
Cordoba, Andalucía, Spain
Milan, Lombardia, Italy
Krems, , Austria
Buenos Aires, , Argentina
Hobart, Tasmania, Australia
Taichung, , Taiwan
Aalborg, Nordjylland, Denmark
Vandoeuvre Lès Nancy, Lorraine, France
Trento, , Italy
Chicoutimi, Quebec, Canada
Strasbourg, Alsace, France
Pamplona, Navarra, Spain
Copenhagen, Hovedstaden, Denmark
London, London, City Of, United Kingdom
Mineola, New York, United States
Madrid, Madrid, Comunidad De, Spain
Quebec City, Quebec, Canada
Westwood, Kansas, United States
Charleston, South Carolina, United States
Viña Del Mar, , Chile
Brno, , Czechia
Majadahonda, Madrid, Comunidad De, Spain
Northwood, Hillingdon, United Kingdom
Le Mans, Sarthe, France
Heidelberg, , Germany
Malvern, Victoria, Australia
Gdansk, Pomorskie, Poland
London, Sutton, United Kingdom
Port Macquarie, New South Wales, Australia
Copenhagen, Hovedstaden, Denmark
Cluj, , Romania
Rimouski, Quebec, Canada
Santiago, Región Metropolitana De Santiago, Chile
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Mayaguez, , Puerto Rico
Austin, Texas, United States
Albuquerque, New Mexico, United States
Iași, , Romania
Glasgow, Glasgow City, United Kingdom
Santiago, Región Metropolitana De Santiago, Chile
Barakaldo, Bizkaia, Spain
Kurralta Park, South Australia, Australia
Viedma, R, Argentina
Austin, Texas, United States
Birmingham, Alabama, United States
Gilbert, Arizona, United States
La Jolla, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Francisco, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Athens, Georgia, United States
Chicago, Illinois, United States
Westwood, Kansas, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Frederick, Maryland, United States
Towson, Maryland, United States
Minneapolis, Minnesota, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Syracuse, New York, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Myrtle Beach, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Murray, Utah, United States
Charlottesville, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Vancouver, Washington, United States
Milwaukee, Wisconsin, United States
Caba, Buenos Aires, Argentina
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Abb, Ciudad Autónoma De Buenos Aires, Argentina
Río Cuarto, Córdoba, Argentina
Viedma, R, Argentina
Buenos Aires, , Argentina
Cordoba, , Argentina
Campbelltown, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Macquarie University, New South Wales, Australia
Port Macquarie, New South Wales, Australia
Wahroonga, New South Wales, Australia
Brisbane, Queensland, Australia
Southport, Queensland, Australia
Adelaide, South Australia, Australia
Elizabeth Vale, South Australia, Australia
Kurralta Park, South Australia, Australia
Hobart, Tasmania, Australia
Heidelberg, Victoria, Australia
Malvern, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Murdoch, Western Australia, Australia
Krems, Niederösterreich, Austria
Linz, Oberösterreich, Austria
Salzburg, , Austria
Wien, , Austria
Vitória, Espírito Santo, Brazil
Belo Horizonte, Minas Gerais, Brazil
Natal, Rio Grande Do Norte, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Montréal, Quebec, Canada
Québec, Quebec, Canada
Rimouski, Quebec, Canada
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Viña Del Mar, Valparaíso, Chile
Hefei, Anhui, China
Beijing, Beijing, China
Beijing, Beijing, China
Beijing, Beijing, China
Chongqing, Chongqing, China
Fuzhou, Fujian, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Zhengzhou, Henan, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Changsha, Hunan, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Xi'an, Shaanxi, China
Jinan, Shandong, China
Yantai, Shandong, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Taiyuan, Shanxi, China
Cheng Du, Sichuan, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Urumqi, Xinjiang, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Linhai, Zhejiang, China
Wenzhou, Zhejiang, China
Horovice, Beroun, Czechia
Brno, Brno Město, Czechia
Hradec Kralove, Hradec Králové, Czechia
Olomouc, Olomoucký Kraj, Czechia
Prague, Praha 2, Czechia
Praha, Praha 5, Czechia
Praha 2, , Czechia
Copenhagen, Hovedstaden, Denmark
Copenhagen, Hovedstaden, Denmark
Aarhus, Midtjylland, Denmark
Aalborg, Nordjylland, Denmark
Nice, Alpes Maritimes, France
Strasbourg, Alsace, France
Vandoeuvre Lès Nancy, Lorraine, France
Pierre Bénite, Rhône, France
Le Mans, Sarthe, France
Villejuif, Val De Marne, France
Clermont Ferrand, , France
Paris, , France
München, Bayern, Germany
Lübeck, Schleswig Holstein, Germany
Jena, Thüringen, Germany
Bonn, , Germany
Essen, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Herne, , Germany
Tübingen, , Germany
Wuerzburg, , Germany
Cork, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Milan, Lombardia, Italy
Orbassano, Piemonte, Italy
Rome, Roma, Italy
Padova, Veneto, Italy
Arezzo, , Italy
Foggia, , Italy
Napoli, , Italy
Terni, , Italy
Trento, , Italy
Goyang Si, Kyǒnggi Do, Korea, Republic Of
Seongnam, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Wroclaw, Dolnośląskie, Poland
Warszawa, Mazowieckie, Poland
Opole, Opolskie, Poland
Gdansk, Pomorskie, Poland
Skorzewo, Wielkopolskie, Poland
Bydgoszcz, , Poland
Katowice, , Poland
Bytom, śląskie, Poland
Mayaguez, , Puerto Rico
Craiova, Dolj, Romania
Ploiești, Prahova, Romania
Cluj, , Romania
Cluj, , Romania
Iași, , Romania
Banska Bystrica, Banskobystrický Kraj, Slovakia
Prešov, Prešovský Kraj, Slovakia
Bratislava, , Slovakia
Martin, žilinský Kraj, Slovakia
Cordoba, Andalucía, Spain
Barcelona, Barcelona [Barcelona], Spain
Sabadell, Barcelona [Barcelona], Spain
Barakaldo, Bizkaia, Spain
Santander, Cantabria, Spain
Barcelona, Catalunya [Cataluña], Spain
Lugo, Lugo [Lugo], Spain
Madrid, Madrid, Comunidad De, Spain
Madrid, Madrid, Comunidad De, Spain
Madrid, Madrid, Comunidad De, Spain
Madrid, Madrid, Comunidad De, Spain
Majadahonda, Madrid, Comunidad De, Spain
Pamplona, Navarra, Spain
Ourense, Ourense [Orense], Spain
Badajoz, , Spain
Burgos, , Spain
Granada, , Spain
Madrid, , Spain
Málaga, , Spain
Sevilla, , Spain
Sevilla, , Spain
València, , Spain
Lund, , Sweden
Solna, , Sweden
Uppsala, , Sweden
Gothenburg, , Sweden
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Adana, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Glasgow, Glasgow City, United Kingdom
Northwood, Hillingdon, United Kingdom
London, London, City Of, United Kingdom
London, Sutton, United Kingdom
Manchester, , United Kingdom
Greenslopes, Queensland, Australia
Aurora, Colorado, United States
Mineola, New York, United States
Clermont Ferrand, , France
Washington, District Of Columbia, United States
Philadelphia, Pennsylvania, United States
Greenslopes, Queensland, Australia
Albuquerque, New Mexico, United States
Portland, Oregon, United States
Willow Grove, Pennsylvania, United States
Quebec City, Quebec, Canada
Huizhou, Guangdong, China
Toulouse, Haute Garonne, France
Wroclaw, Dolnośląskie, Poland
Ploiești, , Romania
Toulouse, Haute Garonne, France
München, Bayern, Germany
Changzhou, Jiangsu, China
Campbelltown, New South Wales, Australia
Poznań, Wielkopolskie, Poland
Poznań, Wielkopolskie, Poland
Bydgoszcz, , Poland
Anaheim, California, United States
Caba, Buenos Aires, Argentina
Cordoba, , Argentina
Opole, Opolskie, Poland
Cluj, , Romania
Martin, žilinský Kraj, Slovakia
Taoyuan, , Taiwan
Santiago, , Chile
Santiago, , Chile
Lakewood, Colorado, United States
Lakeland, Florida, United States
Abb, , Argentina
Río Cuarto, , Argentina
Vitória, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
Montreal, Quebec, Canada
Valdivia, Los Rios, Chile
Hradec Kralove, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Prague, , Czechia
Nürtingen, , Germany
Jena, , Germany
Arezzo, , Italy
Foggia, , Italy
Wroclaw, , Poland
Bytom, , Poland
Ploiești, Prahova, Romania
Banska Bystrica, , Slovakia
Prešov, , Slovakia
Martin, , Slovakia
Barcelona, , Spain
Barcelona, , Spain
Lugo, , Spain
Madrid, , Spain
Ourense, , Spain
Lund, , Sweden
Ankara, , Turkey
Sewell, New Jersey, United States
Milano, , Italy
Warszawa, Mazowieckie, Poland
Bytom, , Poland
Cordoba, , Argentina
Catania, , Italy
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported