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

• ClinicalTrials.gov Identifier: NCT04100018
• Recruitment Status: Recruiting
• First Posted: September 23, 2019
• Last Update Posted: December 21, 2022
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: September 20, 2019
• First Posted Date: September 23, 2019
• Last Update Posted Date: December 21, 2022
• Actual Study Start Date: February 6, 2020
• Estimated Primary Completion Date: April 16, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 19, 2022)

• Radiographic progressive free survival (rPFS) assessed by Blinded Independent Central Review (BICR) per Prostate Cancer Working Group (PCWG3) [ Time Frame: From the date of randomization to the first date of documented progression or death due to any cause, whichever occurs first, approximately 31 months ]
  Up to 530 rPFS events
• Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death from any cause, approximately 51 months. For participants who are alive, their survival time will be censored at the last date that they were known to be alive ]

Original Primary Outcome Measures (submitted: September 20, 2019)

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

Current Secondary Outcome Measures (submitted: December 19, 2022)

• Objective Response Rate (ORR) per PCWG3 [ Time Frame: From the date of randomization to the date of objectively documented progression or the date of subsequent systemic cancer therapy, whichever occurs first, approximately 31 months ]
• Time to Response per PCWG3 (TTR-PCWG3) determined by BICR [ Time Frame: From the date of randomization to the date of the first documented complete response (CR) or partial response (PR), approximately 31 months ]
• Duration of Response (DOR) per PCWG3 determined by BICR [ Time Frame: From the date of first response (CR/PR) to the date of first documented radiographic progression, or death due to any cause, approximately 31 months ]
• Prostate-specific antigen (PSA) Response Rate (PSA-RR) [ Time Frame: Approximately 31 months ]
• Time to PSA Progression (TTP-PSA) [ Time Frame: From date of randomization to the date of PSA progression per PCWG3, approximately 31 months ]
• Incidence of Adverse Events (AEs) [ Time Frame: Approximately 31 months ]
• Incidence of Serious Adverse Events (SAEs) [ Time Frame: Approximately 31 months ]
• Incidence of AEs leading to discontinuation [ Time Frame: Approximately 31 months ]
• Incidence of immune-mediated AEs [ Time Frame: Approximately 31 months ]
• Incidence of deaths [ Time Frame: Approximately 31 months ]
• Incidence of laboratory abnormalities: Clinical Chemistry Tests [ Time Frame: Approximately 31 months ]
• Incidence of laboratory abnormalities: Hematology tests [ Time Frame: Approximately 31 months ]
• Incidence of laboratory abnormalities: Serology tests [ Time Frame: Approximately 31 months ]
• Median time to pain progression assessed by Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Approximately 31 months ]
• Incidence of changes from baseline in Physical Exam [ Time Frame: Approximately 31 months ]
• Incidence of changes from baseline in vital signs: Respiratory rate [ Time Frame: Approximately 31 months ]
• Incidence of changes from baseline in vital signs: Body temperature [ Time Frame: Approximately 31 months ]
• Incidence of changes from baseline in vital signs: Blood pressure [ Time Frame: Approximately 31 months ]
• Incidence of changes from baseline in vital signs: Heart Rate [ Time Frame: Approximately 31 months ]
• Incidence of changes from baseline electrocardiogram (ECG) [ Time Frame: Approximately 31 months ]

Original Secondary Outcome Measures (submitted: September 20, 2019)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
• 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
• Brief Summary: The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Double-Blinded

Primary Purpose: Treatment

• Condition: Prostate Cancer

Intervention

• Biological: Nivolumab
  Specified dose on specified days
  Other Names:

  • OPDIVO,
  • BMS-936558-01
• Drug: Prednisone
  Specified dose on specified days
• Drug: Docetaxel
  Specified dose on specified days
• Other: Placebo
  Specified dose on specified days

Study Arms

• Experimental: Arm A: Nivolumab + docetaxel + prednisone
  Interventions:

  • Biological: Nivolumab
  • Drug: Prednisone
  • Drug: Docetaxel
• Placebo Comparator: Arm B: Placebo + docetaxel + prednisone
  Interventions:

  • Drug: Prednisone
  • Drug: Docetaxel
  • Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 20, 2019): 984
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 13, 2027
• Estimated Primary Completion Date: April 16, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histologic confirmation of adenocarcinoma of the prostate without small cell features
• 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)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
• Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
• Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy
• Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.
• Men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

• Active brain metastases
• Active, known, or suspected autoimmune disease
• Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
• Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel

Other protocol-defined inclusion/exclusion criteria apply

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com; 855-907-3286; Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Mexico, New Zealand, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States

Administrative Information

• NCT Number: NCT04100018
• Other Study ID Numbers: CA209-7DX; 2019-002030-36 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: December 2022