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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36.5 months

Awards & highlights

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.

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 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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

Dexamethasone

FDA approved

Pembrolizumab

FDA approved

Docetaxel

FDA approved

Prednisone

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,253 Total Patients Enrolled

6 Trials studying Prostate Cancer

15,103 Patients Enrolled for Prostate Cancer

Merck Sharp & Dohme LLCLead Sponsor

3,887 Previous Clinical Trials

5,053,944 Total Patients Enrolled

27 Trials studying Prostate Cancer

16,997 Patients Enrolled for Prostate Cancer

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,062,834 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-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.