A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer (CheckMate 7DX)
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ClinicalTrials.gov Identifier: NCT04100018 |
Recruitment Status :
Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : November 26, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Biological: nivolumab Drug: prednisone Drug: docetaxel | Phase 3 |
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 |

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 |
- Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG3) [ Time Frame: Approxmiately 2 years ]
- Overall Survival (OS) [ Time Frame: Approxmiately 3 years ]
- Objective Response Rate (ORR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: Approxmiately 3 years ]
- Duration of response (DOR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: Approxmiately 3 years ]
- PSA Response Rate (PSA-RR) [ Time Frame: Approxmiately 3 years ]
- Time to Response per PCWG3 (TTR-PCWG3) assessed by BICR [ Time Frame: Approxmiately 3 years ]
- Time to pain progression [ Time Frame: Approxmiately 3 years ]
- Time to PSA Progression (TTP-PSA) [ Time Frame: Approxmiately 3 years ]
- Incidence of AEs (Adverse Events) [ Time Frame: Approxmiately 3 years ]
- Incidence of SAEs ( Serious Adverse Events) [ Time Frame: Approxmiately 3 years ]

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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 |
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

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

Additional Information:




Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT04100018 History of Changes |
Other Study ID Numbers: |
CA209-7DX |
First Posted: | September 23, 2019 Key Record Dates |
Last Update Posted: | November 26, 2019 |
Last Verified: | November 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |