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A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer (CheckMate 7DX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04100018
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to test the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: nivolumab Drug: prednisone Drug: docetaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 984 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Estimated Study Start Date : December 16, 2019
Estimated Primary Completion Date : February 20, 2023
Estimated Study Completion Date : May 14, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm A: (nivolumab + docetaxel + prednisone) Biological: nivolumab
specified dose on specified days

Drug: prednisone
specified dose on specified days

Drug: docetaxel
specified dose on specified days

Active Comparator: Arm B: (placebo + docetaxel + prednisone) Drug: prednisone
specified dose on specified days

Drug: docetaxel
specified dose on specified days




Primary Outcome Measures :
  1. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG3) [ Time Frame: Approxmiately 2 years ]
  2. Overall Survival (OS) [ Time Frame: Approxmiately 3 years ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: Approxmiately 3 years ]
  2. Duration of response (DOR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: Approxmiately 3 years ]
  3. PSA Response Rate (PSA-RR) [ Time Frame: Approxmiately 3 years ]
  4. Time to Response per PCWG3 (TTR-PCWG3) assessed by BICR [ Time Frame: Approxmiately 3 years ]
  5. Time to pain progression [ Time Frame: Approxmiately 3 years ]
  6. Time to PSA Progression (TTP-PSA) [ Time Frame: Approxmiately 3 years ]
  7. Incidence of AEs (Adverse Events) [ Time Frame: Approxmiately 3 years ]
  8. Incidence of SAEs ( Serious Adverse Events) [ Time Frame: Approxmiately 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Histologic confirmation of adenocarcinoma of the prostate and evidence of stage IV disease
  • Must have ECOG performance status 0-1
  • Documented prostate cancer progression per PCWG3 criteria within 6 months prior to screening
  • Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
  • Participants who are chemotherapy-naive and received 1 to 2 prior second generation hormonal therapies
  • Sufficient tumor sample from fresh or archival tumor tissue obtained no more than 1 year prior to enrollment, from a metastatic lesion or primary tumor lesion that has not been previously irradiated

Exclusion Criteria:

  • Participants with active brain metastases
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
  • Participants with an active, known, or suspected autoimmune disease
  • Participants requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Prior treatment with docetaxel or another chemotherapy for metastatic castration resistant prostate cancer

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100018


Locations
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United States, Alaska
Local Institution
Anchorage, Alaska, United States, 99503
Contact: Site 0012         
United States, Arizona
Local Institution
Scottsdale, Arizona, United States, 85258
Contact: Site 0148         
United States, California
Local Institution
Rancho Mirage, California, United States, 92270
Contact: Site 0055         
Local Institution
Santa Monica, California, United States, 90404
Contact: Site 0081         
United States, Colorado
Local Institution
Denver, Colorado, United States, 80211-5222
Contact: Site 0087         
United States, Florida
Local Institution
Port Saint Lucie, Florida, United States, 34952
Contact: Site 0002         
United States, Georgia
Local Institution
Atlanta, Georgia, United States, 30342
Contact: Site 0117         
Local Institution
Marietta, Georgia, United States, 30060
Contact: Site 0126         
United States, Maryland
Local Institution
Baltimore, Maryland, United States, 21201
Contact: Site 0150         
United States, New Jersey
Local Institution
Florham Park, New Jersey, United States, 07932
Contact: Site 0139         
United States, New York
Local Institution
New York, New York, United States, 10032
Contact: Site 0092         
Local Institution
Port Jefferson Station, New York, United States, 11776
Contact: Site 0028         
Local Institution
Poughkeepsie, New York, United States, 12601
Contact: Site 0075         
United States, Pennsylvania
Local Institution
Bala-Cynwyd, Pennsylvania, United States, 19004
Contact: Site 0074         
United States, South Carolina
Local Institution
Myrtle Beach, South Carolina, United States, 29572
Contact: Site 0115         
United States, Tennessee
Local Institution
Memphis, Tennessee, United States, 38138
Contact: Site 0149         
United States, Texas
Local Institution
Dallas, Texas, United States, 75231
Contact: Site 0134         
Local Institution
San Antonio, Texas, United States, 78229
Contact: Site 0011         
United States, Washington
Local Institution
Seattle, Washington, United States, 98101
Contact: Site 0019         
Local Institution
Seattle, Washington, United States, 98109
Contact: Site 0110         
Argentina
Local Institution
Mar Del Plata, Buenos Aires, Argentina, 7600
Contact: Site 0129         
Local Institution
Pergamino, Buenos Aires, Argentina
Contact: Site 0061         
Local Institution
Viedma, RIO Negro, Argentina, 8500
Contact: Site 0083         
Local Institution
Rosario, Santa FE, Argentina, 2000
Contact: Site 0078         
Local Institution
Buenos Aires, Argentina, 1280
Contact: Site 0077         
Local Institution
Cordoba, Argentina, 5000
Contact: Site 0153         
Australia, New South Wales
Local Institution
Lismore, New South Wales, Australia, 2480
Contact: Site 0091         
Local Institution
Wahroonga, New South Wales, Australia, 2076
Contact: Site 0132         
Local Institution
Westmead, New South Wales, Australia, 2145
Contact: Site 0127         
Australia, Queensland
Local Institution
Herston, Queensland, Australia, 4006
Contact: Site 0006         
Local Institution
Woolloongabba, Queensland, Australia, 4012
Contact: Site 0084         
Australia, South Australia
Local Institution
North Adelaide, South Australia, Australia, 5006
Contact: Site 0010         
Australia, Victoria
Local Institution
Frankston, Victoria, Australia, 3199
Contact: Site 0040         
Local Institution
Malvern, Victoria, Australia, 3144
Contact: Site 0032         
Austria
Local Institution
Linz, Austria, 4020
Contact: Site 0118         
Local Institution
Salzburg, Austria, 5020
Contact: Site 0038         
Local Institution
Vienna, Austria, 1020
Contact: Site 0157         
Local Institution
Wien, Austria, 1090
Contact: Site 0131         
Belgium
Local Institution
Anderlecht, Belgium, 1070
Contact: Site 0122         
Local Institution
Brugge, Belgium, 8000
Contact: Site 0121         
Local Institution
Gent, Belgium, 9000
Contact: Site 0114         
Local Institution
Gent, Belgium, 9000
Contact: Site 0162         
Local Institution
Turnhout, Belgium, 2300
Contact: Site 0137         
Local Institution
Wilrijk, Belgium, 2610
Contact: Site 0029         
Brazil
Local Institution
Belo Horizonte, Minas Gerais, Brazil, 30110022
Contact: Site 0097         
Local Institution
Belo Horizonte, Minas Gerais, Brazil, 30130-090
Contact: Site 0022         
Local Institution
Curitiba, Parana, Brazil, 80530-010
Contact: Site 0100         
Local Institution
Curitiba, Parana, Brazil, 81480-580
Contact: Site 0082         
Local Institution
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Contact: Site 0058         
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
Contact: Site 0056         
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 90110-270
Contact: Site 0057         
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 90560-030
Contact: Site 0063         
Local Institution
Campinas, SAO Paulo, Brazil, 13083 970
Contact: Site 0086         
Local Institution
Santo Andre, SAO Paulo, Brazil, 09080-000
Contact: Site 0059         
Local Institution
Sao Jose Do Rio Preto, SAO Paulo, Brazil, 15090-000
Contact: Site 0096         
Local Institution
Rio de Janeiro, Brazil, 22793-080
Contact: Site 0060         
Local Institution
S?o Paulo, Brazil, 01321-001
Contact: Site 0080         
Local Institution
Sao Paulo, Brazil, 01308-060
Contact: Site 0021         
Canada, Ontario
Local Institution
Brampton, Ontario, Canada, L6R 3J7
Contact: Site 0151         
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H2X 0A9
Contact: Site 0143         
Chile
Local Institution
Recoleta, Metropolitana, Chile, 8380455
Contact: Site 0025         
Local Institution
Santiago, Metropolitana, Chile, 7630372
Contact: Site 0026         
Local Institution
Vina del Mar, Valparaiso, Chile, 2520598
Contact: Site 0027         
China, Beijing
Local Institution
Beijing, Beijing, China, 100034
Contact: Site 0140         
China, Chongqing
Local Institution
Chongqing, Chongqing, China, 400042
Contact: Site 0054         
China, Liaoning
Local Institution
Shenyang, Liaoning, China, 110042
Contact: Site 0161         
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200032
Contact: Site 0155         
Czechia
Local Institution
Brno, Czechia, 60200
Contact: Site 0108         
Local Institution
Brno, Czechia, 656 91
Contact: Site 0093         
Local Institution
Olomouc, Czechia, 779 00
Contact: Site 0049         
Local Institution
Ostrava-Poruba, Czechia, 70852
Contact: Site 0088         
Local Institution
Praha 4, Czechia, 140 59
Contact: Site 0050         
France
Local Institution
Lille, Cedex, France, 59000
Contact: Site 0079         
Local Institution
ANGERS Cedex 2, France, 49055
Contact: Site 0107         
Local Institution
Hyeres, France, 83400
Contact: Site 0030         
Local Institution
Montpellier, France, 34295
Contact: Site 0109         
Local Institution
Nimes Cedex 09, France, 30029
Contact: Site 0068         
Local Institution
Paris, France, 75014
Contact: Site 0106         
Local Institution
Paris, France, 75015
Contact: Site 0071         
Local Institution
Pierre Benita, France, 69310
Contact: Site 0133         
Local Institution
Strasbourg, France, 67200
Contact: Site 0105         
Germany
Local Institution
Bonn, Germany, 53127
Contact: Site 0089         
Local Institution
Dresden, Germany, 01307
Contact: Site 0090         
Local Institution
Erlangen, Germany, 91054
Contact: Site 0142         
Local Institution
Essen, Germany, 45147
Contact: Site 0144         
Local Institution
Frankfurt am Main, Germany, 60590
Contact: Site 0018         
Local Institution
Hamburg, Germany, 20246
Contact: Site 0064         
Local Institution
Hamburg, Germany, 22763
Contact: Site 0069         
Local Institution
Koblenz, Germany, 56068
Contact: Site 0014         
Local Institution
Luebeck, Germany, 23538
Contact: Site 0147         
Local Institution
Magdeburg, Germany, 39120
Contact: Site 0004         
Local Institution
Muenster, Germany, 48149
Contact: Site 0036         
Local Institution
Nuertingen, Germany, 72622
Contact: Site 0023         
Hong Kong
Local Institution
Hong Kong, Hong Kong, 999077
Contact: Site 0045         
Local Institution
Hong Kong, Hong Kong
Contact: Site 0145         
Local Institution
Hong Kong, Hong Kong
Contact: Site 0146         
Israel
Local Institution
Haifa, Israel, 3109601
Contact: Site 0072         
Local Institution
Petah Tikva, Israel, 49100
Contact: Site 0128         
Local Institution
Ramat-gan, Israel, 52621
Contact: Site 0135         
Local Institution
Tel Aviv, Israel, 6423906
Contact: Site 0138         
Italy
Local Institution
Bergamo, Italy, 24127
Contact: Site 0001         
Local Institution
Bologna, Italy, 40138
Contact: Site 0111         
Local Institution
Brescia, Italy, 25123
Contact: Site 0039         
Local Institution
Cremona, Italy, 26100
Contact: Site 0053         
Local Institution
Milano, Italy, 20141
Contact: Site 0066         
Local Institution
Napoli, Italy, 80131
Contact: Site 0120         
Local Institution
Orbassano, Italy, 10043
Contact: Site 0070         
Local Institution
Parma, Italy, 43126
Contact: Site 0037         
Local Institution
Roma, Italy, 00128
Contact: Site 0046         
Local Institution
Trento, Italy, 38122
Contact: Site 0067         
Korea, Republic of
Local Institution
Yangsan, Korea, Republic of, 626 770
Contact: Site 0158         
Mexico
Local Institution
Morelia, Michoacan, Mexico, 58260
Contact: Site 0062         
Local Institution
Aguascalientes, Mexico, 20010
Contact: Site 0015         
Local Institution
Mexico, Mexico
Contact: Site 0017         
Local Institution
Zapopan, Mexico
Contact: Site 0016         
New Zealand
Local Institution
Hamilton, New Zealand, 3240
Contact: Site 0101         
Poland
Local Institution
Koszalin, Poland, 75-581
Contact: Site 0136         
Local Institution
Lodz, Poland, 93-513
Contact: Site 0009         
Local Institution
Lublin, Poland, 20-090
Contact: Site 0013         
Local Institution
Poznan, Poland, 60-848
Contact: Site 0065         
Local Institution
Warsaw, Poland, 02616
Contact: Site 0095         
Romania
Local Institution
Bucharest, Romania, 022328
Contact: Site 0042         
Local Institution
Cluj Napoca, Romania, 400015
Contact: Site 0041         
Local Institution
Cluj Napoca, Romania, 400015
Contact: Site 0043         
Local Institution
Constanta, Romania, 900591
Contact: Site 0020         
Local Institution
Craiova, Romania, 200347
Contact: Site 0052         
Local Institution
Timisoara, Romania, 300239
Contact: Site 0035         
Russian Federation
Local Institution
Arkhangelsk, Russian Federation, 163045
Contact: Site 0125         
Local Institution
Kazan, Russian Federation, 420029
Contact: Site 0159         
Local Institution
Moscow, Russian Federation, 105077
Contact: Site 0099         
Local Institution
Moscow, Russian Federation, 115478
Contact: Site 0156         
Local Institution
Moscow, Russian Federation, 117997
Contact: Site 0007         
Local Institution
Omsk, Russian Federation, 644013
Contact: Site 0103         
Local Institution
Saint-Petersburg, Russian Federation, 197136
Contact: Site 0160         
Local Institution
Saint-Petersburg, Russian Federation, 197758
Contact: Site 0085         
Singapore
Local Institution
Singapore, Singapore, 169610
Contact: Site 0116         
Local Institution
Singapore, Singapore, 258499
Contact: Site 0005         
Spain
Local Institution
Badalona, Barcelona, Spain, 08916
Contact: Site 0073         
Local Institution
Girona, Spain, 17007
Contact: Site 0044         
Local Institution
L'Hospitalet Del Llobregat, Spain, 08908
Contact: Site 0123         
Local Institution
Lugo, Spain, 27003
Contact: Site 0034         
Local Institution
Madrid, Spain, 28006
Contact: Site 0076         
Local Institution
Madrid, Spain, 28033
Contact: Site 0024         
Local Institution
Madrid, Spain, 28034
Contact: Site 0003         
Local Institution
Madrid, Spain, 28041
Contact: Site 0031         
Local Institution
Manresa, Spain, 08243
Contact: Site 0141         
Local Institution
Sabadell, Spain, 08208
Contact: Site 0124         
Turkey
Local Institution
Adana, Turkey, 01330
Contact: Site 0094         
Local Institution
Ankara, Turkey, 06230
Contact: Site 0130         
Local Institution
Istanbul, Turkey, 34098
Contact: Site 0113         
Local Institution
Izmir, Turkey, 35575
Contact: Site 0104         
Local Institution
Malatya, Turkey, 44280
Contact: Site 0112         
Local Institution
Mamak/Ankara, Turkey, 06590
Contact: Site 0119         
United Kingdom
Local Institution
Northwood, Middlesex, United Kingdom, HA6 2RN
Contact: Site 0008         
Local Institution
Blackburn, United Kingdom, BB2 3HH
Contact: Site 0033         
Local Institution
Guildford, United Kingdom, GU2 7XX
Contact: Site 0048         
Local Institution
London, United Kingdom, EC1A 7BE
Contact: Site 0047         
Local Institution
London, United Kingdom, SE1 9RT
Contact: Site 0163         
Local Institution
Manchester, United Kingdom, M20 4BX
Contact: Site 0098         
Local Institution
Nottingham, United Kingdom, NG5 1PB
Contact: Site 0051         
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04100018    
Other Study ID Numbers: CA209-7DX
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Nivolumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal