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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04100018




Registration number
NCT04100018
Ethics application status
Date submitted
20/09/2019
Date registered
23/09/2019
Date last updated
17/05/2024

Titles & IDs
Public title
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
Scientific title
A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer
Secondary ID [1] 0 0
2019-002030-36
Secondary ID [2] 0 0
CA209-7DX
Universal Trial Number (UTN)
Trial acronym
CheckMate 7DX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Nivolumab
Treatment: Drugs - Prednisone
Treatment: Drugs - Docetaxel
Other interventions - Placebo

Experimental: Arm A: Nivolumab + docetaxel + prednisone -

Placebo Comparator: Arm B: Placebo + docetaxel + prednisone -


Other interventions: Nivolumab
Specified dose on specified days

Treatment: Drugs: Prednisone
Specified dose on specified days

Treatment: Drugs: Docetaxel
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic progressive free survival (rPFS) assessed by Blinded Independent Central Review (BICR) per Prostate Cancer Working Group (PCWG3)
Timepoint [1] 0 0
From the date of randomization to the first date of documented progression or death due to any cause, whichever occurs first, approximately 31 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
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
Secondary outcome [1] 0 0
Objective Response Rate (ORR) per PCWG3
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Time to Response per PCWG3 (TTR-PCWG3) determined by BICR
Timepoint [2] 0 0
From the date of randomization to the date of the first documented complete response (CR) or partial response (PR), approximately 31 months
Secondary outcome [3] 0 0
Duration of Response (DOR) per PCWG3 determined by BICR
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Prostate-specific antigen (PSA) Response Rate (PSA-RR)
Timepoint [4] 0 0
Approximately 31 months
Secondary outcome [5] 0 0
Time to PSA Progression (TTP-PSA)
Timepoint [5] 0 0
From date of randomization to the date of PSA progression per PCWG3, approximately 31 months
Secondary outcome [6] 0 0
Incidence of Adverse Events (AEs)
Timepoint [6] 0 0
Approximately 31 months
Secondary outcome [7] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [7] 0 0
Approximately 31 months
Secondary outcome [8] 0 0
Incidence of AEs leading to discontinuation
Timepoint [8] 0 0
Approximately 31 months
Secondary outcome [9] 0 0
Incidence of immune-mediated AEs
Timepoint [9] 0 0
Approximately 31 months
Secondary outcome [10] 0 0
Incidence of deaths
Timepoint [10] 0 0
Approximately 31 months
Secondary outcome [11] 0 0
Incidence of laboratory abnormalities: Clinical Chemistry Tests
Timepoint [11] 0 0
Approximately 31 months
Secondary outcome [12] 0 0
Incidence of laboratory abnormalities: Hematology tests
Timepoint [12] 0 0
Approximately 31 months
Secondary outcome [13] 0 0
Incidence of laboratory abnormalities: Serology tests
Timepoint [13] 0 0
Approximately 31 months
Secondary outcome [14] 0 0
Median time to pain progression assessed by Brief Pain Inventory-Short Form (BPI-SF)
Timepoint [14] 0 0
Approximately 31 months
Secondary outcome [15] 0 0
Incidence of changes from baseline in Physical Exam
Timepoint [15] 0 0
Approximately 31 months
Secondary outcome [16] 0 0
Incidence of changes from baseline in vital signs: Respiratory rate
Timepoint [16] 0 0
Approximately 31 months
Secondary outcome [17] 0 0
Incidence of changes from baseline in vital signs: Body temperature
Timepoint [17] 0 0
Approximately 31 months
Secondary outcome [18] 0 0
Incidence of changes from baseline in vital signs: Blood pressure
Timepoint [18] 0 0
Approximately 31 months
Secondary outcome [19] 0 0
Incidence of changes from baseline in vital signs: Heart Rate
Timepoint [19] 0 0
Approximately 31 months
Secondary outcome [20] 0 0
Incidence of changes from baseline electrocardiogram (ECG)
Timepoint [20] 0 0
Approximately 31 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/06/2024
Actual
Sample size
Target
Accrual to date
Final
1095
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Local Institution - 0152 - Gosford
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Local Institution - 0091 - Lismore
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Local Institution - 0127 - Westmead
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Local Institution - 0010 - North Adelaide
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Local Institution - 0379 - Ballarat
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2250 - Gosford
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2480 - Lismore
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2076 - Wahroonga
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2145 - Westmead
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4101 - South Brisbane
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4102 - Woolloongabba
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5006 - North Adelaide
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3350 - Ballarat
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3199 - Frankston
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3144 - Malvern
Recruitment outside Australia
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Chiba
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Ehime
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Kumamoto
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Kyoto
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Daegu
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Taiwan
State/province [189] 0 0
Kaohsiung
Country [190] 0 0
Taiwan
State/province [190] 0 0
Taichung
Country [191] 0 0
Taiwan
State/province [191] 0 0
Tainan
Country [192] 0 0
Taiwan
State/province [192] 0 0
Taipei
Country [193] 0 0
Turkey
State/province [193] 0 0
Adana
Country [194] 0 0
Turkey
State/province [194] 0 0
Ankara
Country [195] 0 0
Turkey
State/province [195] 0 0
Istanbul
Country [196] 0 0
Turkey
State/province [196] 0 0
Izmir
Country [197] 0 0
Turkey
State/province [197] 0 0
Malatya
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Greater London
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Lancashire
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Middlesex
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Nottinghamshire
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Oxfordshire
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Surrey
Country [204] 0 0
United Kingdom
State/province [204] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04100018
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04100018