Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : October 31, 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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


  Show 117 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
Layout table for additonal 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: October 31, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
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