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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/NCT03834506
Registration number
NCT03834506
Ethics application status
Date submitted
6/02/2019
Date registered
8/02/2019
Date last updated
25/08/2023
Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)
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Scientific title
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)
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Secondary ID [1]
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MK-3475-921
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Secondary ID [2]
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3475-921
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Pembrolizumab
Treatment: Drugs - Docetaxel
Treatment: Drugs - Prednisone
Treatment: Drugs - Placebo
Treatment: Drugs - Dexamethasone
Experimental: Pembrolizumab+Docetaxel - Participants receive pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.
Placebo Comparator: Placebo+Docetaxel - Participants receive placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m^2 by IV infusion Q3W for a maximum of 10 cycles (approximately 7 months). Participants also receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each docetaxel cycle.
Other interventions: Pembrolizumab
IV infusion
Treatment: Drugs: Docetaxel
IV infusion
Treatment: Drugs: Prednisone
Oral tablets
Treatment: Drugs: Placebo
IV infusion
Treatment: Drugs: Dexamethasone
Oral tablets
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
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Timepoint [1]
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Up to 36.5 months
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Primary outcome [2]
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Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [2]
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rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per RECIST 1.1 was =20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of =2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for =6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.
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Timepoint [2]
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Up to approximately 28 months
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Secondary outcome [1]
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Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
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Assessment method [1]
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TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit (Kaplan-Meier) method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received.
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Timepoint [1]
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Up to approximately 28 months
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Secondary outcome [2]
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Prostate-specific Antigen (PSA) Response Rate
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Assessment method [2]
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The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by =50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed =3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements.
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Timepoint [2]
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Up to 36.5 months
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Secondary outcome [3]
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Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
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Assessment method [3]
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ORR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).
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Timepoint [3]
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Up to 36.5 months
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Secondary outcome [4]
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Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
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Assessment method [4]
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DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD per PCWG was the appearance of =2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for =6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.
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Timepoint [4]
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Up to 36.5 months
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Secondary outcome [5]
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Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score
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Assessment method [5]
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TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF and by the AQA score. Pain progression was defined as:
For participants asymptomatic at baseline: a =2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain
For participants symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids:, a =2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score =4 and no decrease in average opioid use (=1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.
TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had > 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.
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Timepoint [5]
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Up to 36.5 months
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Secondary outcome [6]
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Time to First Symptomatic Skeletal-related Event (SSRE)
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Assessment method [6]
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SSRE was the time from randomization to the first symptomatic skeletal-related event defined as:
Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms
Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral)
Occurrence of spinal cord compression
Tumor-related orthopedic surgical intervention, whichever occurs first.
The SSRE was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.
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Timepoint [6]
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Up to 36.5 months
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Secondary outcome [7]
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Time to Prostate-specific Antigen (PSA) Progression
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Assessment method [7]
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The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of:
=25% increase and =2 ng/mL above the nadir, confirmed by a second value =3 weeks later if there was PSA decline from baseline; OR
=25% increase and =2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline
Time to PSA progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment.
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Timepoint [7]
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Up to 36.5 months
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Secondary outcome [8]
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Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
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Assessment method [8]
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The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of =5 mm. The appearance of one or more new lesions was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.
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Timepoint [8]
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Up to 36.5 months
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Secondary outcome [9]
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Number of Participants Who Experienced an Adverse Event (AE)
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Assessment method [9]
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An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.
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Timepoint [9]
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Up to approximately 30 months
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Secondary outcome [10]
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Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
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Assessment method [10]
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An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented.
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Timepoint [10]
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Up to approximately 27 months
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Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without
small cell histology
- Has prostate cancer progression while on androgen deprivation therapy (or post
bilateral orchiectomy) within 6 months prior to screening
- Has current evidence of metastatic disease documented by either bone lesions on bone
scan and/or soft tissue disease by computed tomography/magnetic resonance imaging
(CT/MRI)
- Has received prior treatment with one (but not more than one) NHA (eg, abiraterone
acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive
prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a)
progressed through treatment OR b) has become intolerant of the drug
- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
- Participants receiving bone resorptive therapy (including, but not limited to,
bisphosphonate or denosumab) must have been on stable doses prior to randomization
- Participants must agree to the following during the study treatment period and for at
least 120 days after the last dose of pembrolizumab or for at least 180 days after the
last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use
contraception unless confirmed to be azoospermic (vasectomized or secondary to medical
cause)
- Participants must agree to use male condom when engaging in any activity that allows
for passage of ejaculate to another person of any sex
- Has provided newly obtained core or excisional biopsy (obtained within 12 months of
screening) from soft tissue not previously irradiated (samples from tumors progressing
in a prior site of radiation are allowed). Participants with bone only or bone
predominant disease may provide a bone biopsy sample
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed
within 7 days of randomization
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has a known additional malignancy that is progressing or has required active treatment
in the last 3 years
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has undergone major surgery including local prostate intervention (excluding prostate
biopsy) within 28 days prior to randomization and not recovered adequately from the
toxicities and/or complications
- Has a gastrointestinal disorder affecting absorption or is unable to swallow
tablets/capsules
- Has an active infection (including tuberculosis) requiring systemic therapy
- Has a history of (non-infectious) pneumonitis that required steroids or current
pneumonitis
- Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or
hepatitis C virus (HCV) infection
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis
- Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients
- Has symptomatic congestive heart failure (New York Heart Association Class III or IV
heart disease)
- Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who
has not recovered (i.e., Grade =1 or at baseline) from AEs due to mAbs
- Has used herbal products that may have hormonal anti-prostate cancer activity and/or
are known to decrease PSA levels (e.g. saw palmetto) prior to randomization
- Has received prior treatment with radium or other therapeutic radiopharmaceuticals for
prostate cancer
- Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1),
anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent
directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic
T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
- Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
- Has hypersensitivity to docetaxel or polysorbate 80
- Is currently receiving either strong or moderate inhibitors of cytochrome P450
(CYP)3A4 that cannot be discontinued for the duration of the study
- Has received prior targeted small molecule therapy or abiraterone acetate,
enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of
study treatment, or has not recovered (i.e., Grade =1 or at baseline) from AEs due to
a previously administered agent
- Has received prior radiotherapy to within 2 weeks of start of study treatment.
Participants must have recovered from all radiation-related toxicities, not require
corticosteroids, and not have had radiation pneumonitis
- Has received a live vaccine within 30 days prior to randomization
- Has received treatment with 5a reductase inhibitors (eg, finasteride or dutasteride),
estrogens, and/or cyproterone within 4 weeks prior to randomization
- Has received prior treatment with ketoconazole for prostate cancer
- Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks prior to the first dose of
study treatment
- Has a "superscan" bone scan
- Is expecting to conceive or father children within the projected duration of the
study, starting with the screening visit through 120 days after the last dose of study
treatment
- Has had an allogenic tissue/solid organ transplant
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/05/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/07/2023
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Sample size
Target
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Accrual to date
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Final
1030
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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St George Hospital ( Site 0157) - Kogarah
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Recruitment hospital [2]
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Macquarie University ( Site 0151) - Macquarie University
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Recruitment hospital [3]
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Port Macquarie Base Hospital ( Site 0153) - Port Macquarie
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Calvary Mater Newcastle ( Site 0148) - Waratah
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Redcliffe Hospital ( Site 0161) - Redcliffe
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Recruitment hospital [6]
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John Flynn Hospital & Medical Centre ( Site 0164) - Tugun
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Recruitment hospital [7]
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Hollywood Private Hospital ( Site 0163) - Nedlands
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2109 - Macquarie University
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Recruitment postcode(s) [3]
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2444 - Port Macquarie
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Recruitment postcode(s) [4]
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2298 - Waratah
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Recruitment postcode(s) [5]
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4020 - Redcliffe
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Recruitment postcode(s) [6]
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4224 - Tugun
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Indiana
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Santa Fe
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Argentina
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Cordoba
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Austria
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Oberosterreich
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Austria
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Steiermark
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Austria
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Salzburg
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Austria
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Wien
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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Sao Paulo
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Araucania
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Chile
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Region M. De Santiago
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Chile
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Valparaiso
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China
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Beijing
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China
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Fujian
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China
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China
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China
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Henan
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China
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China
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China
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Jiangsu
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China
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Shanghai
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China
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Zhejiang
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Colombia
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Antioquia
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Colombia
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Atlantico
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Colombia
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Cesar
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Colombia
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Cordoba
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Colombia
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Distrito Capital De Bogota
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Colombia
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Risaralda
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Colombia
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Valle Del Cauca
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Auvergne
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France
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France
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Doubs
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France
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Finistere
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Gironde
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France
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France
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France
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Loiret
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France
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Meurthe-et-Moselle
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France
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Rhone
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France
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Somme
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France
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France
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Vaucluse
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France
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Paris
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Germany
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Bayern
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Germany
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Germany
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Germany
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Saarland
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Germany
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Thuringen
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Germany
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Berlin
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Cork
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Ireland
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Dublin
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Ireland
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Limerick
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Israel
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Beer Sheva
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Israel
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Beer Yaakov-Zerifin
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Milano
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Italy
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Catania
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Italy
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Modena
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Italy
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Napoli
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Italy
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Roma
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Italy
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Terni
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Italy
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Trento
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Nara
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Yamaguchi
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Japan
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Fukuoka
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Japan
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Miyazaki
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Japan
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Nagasaki
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Japan
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Tokyo
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul
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Netherlands
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Fryslan
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Netherlands
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Gelderland
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Netherlands
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Limburg
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Netherlands
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Overijssel
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Zuid-Holland
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Russian Federation
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Chelyabinskaya Oblast
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Russian Federation
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Krasnoyarskiy Kray
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Russian Federation
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Moskva
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Russian Federation
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Nizhegorodskaya Oblast
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Russian Federation
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Omskaya Oblast
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Russian Federation
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Samarskaya Oblast
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Tomskaya Oblast
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Spain
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Barcelona
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Cantabria
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Spain
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Gerona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Taiwan
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Tainan
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Taichung
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Taipei
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United Kingdom
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Bristol, City Of
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United Kingdom
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Cambridgeshire
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United Kingdom
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Devon
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United Kingdom
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England
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United Kingdom
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Hertfordshire
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United Kingdom
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London, City Of
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United Kingdom
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Staffordshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Ethics approval
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Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of the combination of
pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic
castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but
have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).
There are two primary study hypotheses.
Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to
placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).
Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to
placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival
(rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in
Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03834506
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03834506
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