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Chemotherapy

Pembrolizumab for Prostate Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 36.5 months

Awards & highlights

Pivotal Trial

Study Summary

This trial is assessing whether the addition of pembrolizumab to docetaxel and prednisone improves outcomes in men with mCRPC who have not received prior chemotherapy for mCRPC.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

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)

Secondary outcome measures

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

Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)

Number of Participants Who Experienced an Adverse Event (AE)

+7 more

Side effects data

From 2021 Phase 3 trial • 453 Patients • NCT03066778

54%

Neutropenia

45%

Anaemia

38%

Nausea

34%

Alopecia

31%

Decreased appetite

29%

Constipation

27%

Fatigue

26%

Thrombocytopenia

22%

Leukopenia

21%

Diarrhoea

20%

Cough

17%

Asthenia

17%

Dyspnoea

16%

Vomiting

14%

Pyrexia

14%

Dizziness

13%

Headache

13%

Arthralgia

13%

Rash

12%

Hypothyroidism

11%

Pruritus

11%

Insomnia

11%

Back pain

10%

Weight decreased

Hyponatraemia

Aspartate aminotransferase increased

Pneumonia

Oedema peripheral

Upper respiratory tract infection

Alanine aminotransferase increased

Febrile neutropenia

Abdominal pain

Blood creatinine increased

Hypokalaemia

Abdominal pain upper

Stomatitis

Dry skin

Erythema

Dysgeusia

Hyperthyroidism

Dyspepsia

Dysphagia

Nasopharyngitis

Blood alkaline phosphatase increased

Pain in extremity

Musculoskeletal chest pain

Musculoskeletal pain

Chest pain

Hypertension

Hypotension

Urinary tract infection

Atrial fibrillation

Death

Acute kidney injury

Pneumonitis

Pulmonary embolism

Hemiparesis

Clostridium difficile colitis

Neutropenic sepsis

Pleural infection

Sepsis

Infusion related reaction

Diabetes mellitus

Aortic aneurysm

Inappropriate antidiuretic hormone secretion

Pneumothorax

Transient ischaemic attack

Gastritis

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab+EP

Placebo+EP

Pembrolizumab Second Course

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pembrolizumab+DocetaxelExperimental Treatment4 Interventions

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.

Group II: Placebo+DocetaxelPlacebo Group4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2030

Docetaxel

1995

Completed Phase 4

~5620

Prednisone

2014

Completed Phase 4

~2370

Dexamethasone

2007

Completed Phase 4

~2590

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,579,758 Total Patients Enrolled

6 Trials studying Prostate Cancer

15,103 Patients Enrolled for Prostate Cancer

Merck Sharp & Dohme LLCLead Sponsor

3,822 Previous Clinical Trials

5,013,594 Total Patients Enrolled

27 Trials studying Prostate Cancer

16,898 Patients Enrolled for Prostate Cancer

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,735 Previous Clinical Trials

8,017,187 Total Patients Enrolled

13 Trials studying Prostate Cancer

3,306 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any caps on recruitment for this experiment?

"Unfortunately, this particular study is not looking for any new participants at the moment. Although, it's important to note that the last update was on November 3rd, 2022. There are 1289 other trials searching for patients with prostate cancer and 2155 Pembrolizumab admitting patients right now."

Answered by AI

How many sites are hosting this research project?

"There are 37 medical centres currently conducting this trial, with several notable locations being Durham, Toronto and Cleveland. If you're interested in participating, try to select a site close to minimize travel."

Answered by AI

Can new participants still join this research initiative?

"The latest information from clinicaltrials.gov reports that this trial is not currently enrolling patients. This study was first posted on May 2nd, 2019 and updated November 3rd, 2020. There are other 3400+ trials currently looking for participants."

Answered by AI

What are the chief medical benefits of Pembrolizumab?

"Pembrolizumab is a common treatment for eye conditions. It can also help patients with ulcerative colitis, varicella-zoster virus acute retinal necrosis, and other diseases."

Answered by AI

What are the end goals that researchers hope to achieve with this trial?

"The primary aim of this oncology study, which will span a maximum of 36 months, is to observe and record the Overall Survival rate of participants. Additionally, researchers are looking at secondary objectives such as Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST), Prostate i-cancer Therapy (TFST), Prostate-specific Antigen (PSA) Response Rate, and Duration of Response (DOR)."

Answered by AI

What are the possible dangers of Pembrolizumab?

"Pembrolizumab has received a score of 3 for safety. This is due to the fact that it is in Phase 3 clinical trials, meaning there is significant data supporting both its efficacy and safety."

Answered by AI

Recent research and studies

Future OncologyJournal

KEYNOTE-921: Phase III Study of Pembrolizumab Plus Docetaxel for Metastatic Castration-resistant Prostate Cancer

Petrylak, Daniel P, Raffaele Ratta, Rustem Gafanov, Gaetano Facchini, Josep M Piulats, Gero Kramer, Thomas W Flaig, et al.. 2021. “KEYNOTE-921: Phase III Study of Pembrolizumab Plus Docetaxel for Metastatic Castration-resistant Prostate Cancer”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2020-1133.

clinicaltrials.govStudy

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)

2019. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03834506.