A Phase 3 interventional study of Pembrolizumab and Docetaxel in Prostatic Neoplasms, sponsored by Merck Sharp & Dohme LLC. Completed at 215 sites in 21 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
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.
With Amendment 6 (effective date: 29-Sep-2022), all participants will be unblinded and placebo treatment will be stopping. Participants who are deemed to be deriving clinical benefit from treatment may continue at the discretion of the investigator.
The global study for MK-3475-921 enrolled 1030 participants. Of the 1030 total participants enrolled in the global study, 21 were also enrolled in the China extension study for MK-3475-921 (NCT04907227).
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 1,030 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
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 on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly 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 21-day docetaxel cycle.
Biological: Pembrolizumab · Drug: Docetaxel · Drug: Prednisone · Drug: Dexamethasone
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 on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly 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 21-day docetaxel cycle.
Drug: Docetaxel · Drug: Prednisone · Drug: Placebo · Drug: Dexamethasone
IV infusion
Also known as: MK-3475, KEYTRUDA®
IV infusion
Also known as: TAXOTERE®
Oral tablets
IV infusion
Also known as: Normal saline or dextrose infusion
Oral tablets
Also known as: DECADRON®
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit Kaplan-Meier (K-M) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Time frame: Up to 36.5 months
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)
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. Radiological 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 K-M method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.
Time frame: Up to approximately 28 months
Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
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 K-M 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.
Time frame: Up to approximately 28 months
Prostate-specific Antigen (PSA) Response Rate
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.
Time frame: Up to 36.5 months
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 (BICR)
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).
Time frame: Up to 36.5 months
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 (BICR)
DOR was the time from first documented evidence of 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: ≥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) until progressive disease (PD) or death. PD per RECIST 1.1 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 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 K-M method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.
Time frame: Up to 36.5 months
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
TTPP was the time from randomization to pain progression (PP) based on BPI-SF Item 3 and AQA score. BPI-SF assesses pain intensity; for item 3, participant responses to "Please rate your pain at its worst in the last 24 hours" are scored from 0 (no pain) to 10 (worst pain). A higher score indicates greater pain. AQA captures the intensity of analgesic use in pain management, scored from 0 (no analgesic) to 7 (strong opioid use). A higher score indicates higher intensity of analgesic use. For participants asymptomatic at baseline, PP was ≥2-point change from baseline in BPI-SF item 3 score OR initiation of opioid use. For participants symptomatic at baseline, PP was ≥2-point change from baseline in the BPI-SF Item 3 score, a score of ≥4 and no decrease in average opioid use OR any increase in opioid use (e.g., 1 point change in AQA score). TTPP was assessed by product-limit K-M method. Participants with \>2 consecutive unevaluable visits were censored at the last evaluable assessment.
Time frame: Up to 36.5 months
Time to First Symptomatic Skeletal-related Event (SSRE)
SSRE was the time from randomization to the first symptomatic skeletal-related event defined as: 1. Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms 2. Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral) 3. Occurrence of spinal cord compression 4. Tumor-related orthopedic surgical intervention, whichever occurs first. The SSRE was calculated using the product-limit K-M method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.
Time frame: Up to 36.5 months
Time to Prostate-specific Antigen (PSA) Progression
The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of: 1. ≥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 2. ≥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 K-M method for censored data. Participants without PSA progression were censored at the last evaluable assessment.
Time frame: Up to 36.5 months
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)
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 K-M method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.
Time frame: Up to 36.5 months
Number of Participants Who Experienced an Adverse Event (AE)
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.
Time frame: Up to approximately 30 months
Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
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.
Time frame: Up to approximately 27 months
| Milestone | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| Started | 515 | 515 |
| Treated | 514 | 514 |
| Completed | 0 | 0 |
| Not completed | 515 | 515 |
| Withdrew: Death | 336 | 326 |
| Withdrew: Withdrawal by parent/guardian | 1 | 1 |
| Withdrew: Withdrawal by subject | 10 | 8 |
| Withdrew: Sponsor decision | 165 | 178 |
| Withdrew: Physician decision | 3 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit Kaplan-Meier (K-M) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
| Months | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| Overall Survival (OS) | 19.6 (18.2 to 20.9) | 19.0 (17.9 to 20.9) |
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. Radiological 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 K-M method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.
| Months | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| 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) | 8.6 (8.3 to 10.2) | 8.3 (8.2 to 8.5) |
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 K-M 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.
| Months | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST) | 10.7 (10.4 to 11.1) | 10.4 (9.7 to 11.1) |
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.
| Percentage of participants | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| Prostate-specific Antigen (PSA) Response Rate | 44.5 (40.0 to 49.1) | 45.7 (41.2 to 50.2) |
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).
| Percentage of participants | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| 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 (BICR) | 33.5 (27.0 to 40.4) | 35.3 (29.0 to 42.0) |
DOR was the time from first documented evidence of 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: ≥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) until progressive disease (PD) or death. PD per RECIST 1.1 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 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 K-M method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.
| Months | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| 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 (BICR) | 6.3 (6.1 to 7.8) | 6.2 (6.2 to 6.4) |
TTPP was the time from randomization to pain progression (PP) based on BPI-SF Item 3 and AQA score. BPI-SF assesses pain intensity; for item 3, participant responses to "Please rate your pain at its worst in the last 24 hours" are scored from 0 (no pain) to 10 (worst pain). A higher score indicates greater pain. AQA captures the intensity of analgesic use in pain management, scored from 0 (no analgesic) to 7 (strong opioid use). A higher score indicates higher intensity of analgesic use. For participants asymptomatic at baseline, PP was ≥2-point change from baseline in BPI-SF item 3 score OR initiation of opioid use. For participants symptomatic at baseline, PP was ≥2-point change from baseline in the BPI-SF Item 3 score, a score of ≥4 and no decrease in average opioid use OR any increase in opioid use (e.g., 1 point change in AQA score). TTPP was assessed by product-limit K-M method. Participants with \>2 consecutive unevaluable visits were censored at the last evaluable assessment.
| Months | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| 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 | 21.1 (13.7 to NA) | NA (13.8 to NA) |
SSRE was the time from randomization to the first symptomatic skeletal-related event defined as: 1. Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms 2. Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral) 3. Occurrence of spinal cord compression 4. Tumor-related orthopedic surgical intervention, whichever occurs first. The SSRE was calculated using the product-limit K-M method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.
| Months | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| Time to First Symptomatic Skeletal-related Event (SSRE) | NA (NA to NA) | NA (NA to NA) |
The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of: 1. ≥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 2. ≥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 K-M method for censored data. Participants without PSA progression were censored at the last evaluable assessment.
| Months | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| Time to Prostate-specific Antigen (PSA) Progression | 6.9 (6.2 to 7.6) | 7.0 (6.3 to 7.6) |
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 K-M method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.
| Months | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| 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) | 12.4 (10.7 to 14.9) | 11.2 (10.4 to 12.5) |
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.
| Participants | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | 508 | 505 |
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.
| Participants | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE) | 150 | 115 |
Collected over Up to approximately 48 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pembrolizumab + Docetaxel | 343/515 (66.6%) | 212/514 (41.2%) | 496/514 (96.5%) |
| Placebo + Docetaxel | 329/515 (63.9%) | 197/514 (38.3%) | 488/514 (94.9%) |
| Event | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 28/514 | 22/514 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 15/514 | 6/514 |
| PneumoniaInfections and infestations | 14/514 | 12/514 |
| DiarrhoeaGastrointestinal disorders | 13/514 | 9/514 |
| Urinary tract infectionInfections and infestations | 8/514 | 7/514 |
| HaematuriaRenal and urinary disorders | 8/514 | 4/514 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 6/514 | 8/514 |
| NeutropeniaBlood and lymphatic system disorders | 6/514 | 7/514 |
| Cardiac failureCardiac disorders | 6/514 | 0/514 |
| PyrexiaGeneral disorders | 6/514 | 4/514 |
| Event | Pembrolizumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 209/514 | 184/514 |
| AlopeciaSkin and subcutaneous tissue disorders | 182/514 | 193/514 |
| FatigueGeneral disorders | 183/514 | 184/514 |
| AnaemiaBlood and lymphatic system disorders | 147/514 | 126/514 |
| NauseaGastrointestinal disorders | 124/514 | 135/514 |
| AstheniaGeneral disorders | 132/514 | 128/514 |
| Peripheral sensory neuropathyNervous system disorders | 132/514 | 100/514 |
| ConstipationGastrointestinal disorders | 110/514 | 85/514 |
| Decreased appetiteMetabolism and nutrition disorders | 107/514 | 98/514 |
| Oedema peripheralGeneral disorders | 95/514 | 106/514 |
The baseline analysis population consisted of all randomized participants.
| Age, Continuous(Years) | Pembrolizumab + Docetaxel | Placebo + Docetaxel | Total |
|---|---|---|---|
| Mean | 69.9 ± 7.9 | 70.4 ± 7.1 | 70.1 ± 7.5 |
| Sex: Female, Male(Participants) | Pembrolizumab + Docetaxel | Placebo + Docetaxel | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 515 | 515 | 1030 |
| Ethnicity (NIH/OMB)(Participants) | Pembrolizumab + Docetaxel | Placebo + Docetaxel | Total |
|---|---|---|---|
| Hispanic or Latino | 79 | 77 | 156 |
| Not Hispanic or Latino | 402 | 393 | 795 |
| Unknown or Not Reported | 34 | 45 | 79 |
| Race (NIH/OMB)(Participants) | Pembrolizumab + Docetaxel | Placebo + Docetaxel | Total |
|---|---|---|---|
| American Indian or Alaska Native | 6 | 8 | 14 |
| Asian | 78 | 76 | 154 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 13 | 13 | 26 |
| White | 401 | 399 | 800 |
| More than one race | 15 | 18 | 33 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Prior Treatment with a Next Generation Hormonal Agent (NHA): Abiraterone Acetate(Participants) | Pembrolizumab + Docetaxel | Placebo + Docetaxel | Total |
|---|---|---|---|
| Yes | 278 | 277 | 555 |
| No | 237 | 238 | 475 |
| Type of Metastases at Baseline(Participants) | Pembrolizumab + Docetaxel | Placebo + Docetaxel | Total |
|---|---|---|---|
| Bone only | 268 | 239 | 507 |
| Liver | 34 | 33 | 67 |
| Other | 213 | 243 | 456 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)(Participants) | Pembrolizumab + Docetaxel | Placebo + Docetaxel | Total |
|---|---|---|---|
| ECOG = 0 | 298 | 286 | 584 |
| ECOG = 1 | 212 | 227 | 439 |
| ECOG = 2 | 0 | 0 | 0 |
| ECOG = 3 | 0 | 0 | 0 |
| ECOG = 4 | 1 | 0 | 1 |
| ECOG = 5 | 0 | 0 | 0 |
| Missing | 4 | 2 | 6 |
Showing the first 100 of 215 sites across 21 countries.
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Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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