Pembrolizumab/Vibostolimab coformulation for Castration
Phase-Based Progress Estimates
Effectiveness
Safety
Castration+1 More
Pembrolizumab/Vibostolimab coformulation - BiologicalEligibility
18+
Male
What conditions do you have?
Select
Eligibility
18+
Male
What conditions do you have?
Select
Study Summary
This trial will assess the safety and efficacy of pembrolizumab in combination with other drugs for treating patients with mCRPC. There will be nine cohorts in the study, each receiving different combinations of drugs. Outcome measures will be assessed individually for each cohort.
Eligible Conditions
- Castration
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 8 Secondary · Reporting Duration: Assessed Every 3 Weeks Over the Duration of the Study Which is Estimated to be Approximately 2 Years
Year 2
Number of Participants Discontinuing Study Drug Due to AEs
Number of Participants with Adverse Events (AEs)
Year 2
Composite Response Rate Defined as Any One of the Following: A. Response Based on RECIST 1.1; B. PSA Decrease of ≥50%; or C. Circulating Tumor-cell Count Conversion (Pembrolizumab + Olaparib Cohort Only)
Disease Control Rate (DCR) Based on Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1 Assessed by BICR
Duration of Response (DOR) Based on PCWG3-modified RECIST 1.1 Assessed by BICR
ORR Based on PCWG3-modified RECIST 1.1 Assessed by BICR
ORR Based on PCWG3-modified RECIST 1.1 Criteria Assessed by BICR
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)
Overall Survival (OS)
Radiographic Progression-free Survival (rPFS) Based on PCWG3-modified RECIST 1.1 Assessed by BICR
Time to PSA Progression
Year 2
Percentage of Participants With a Decrease of ≥50% in Prostatic Specific Antigen (PSA)
Trial Safety
Safety Progress
Trial Design
10 Treatment Groups
Carboplatin+Etoposide
1 of 10
Pembrolizumab+Carboplatin+Etoposide
1 of 10
Pembrolizumab/Vibostolimab coformulation
1 of 10
Pembrolizumab+Olaparib
1 of 10
Pembrolizumab+Docetaxel+Prednisone
1 of 10
Pembrolizumab+Enzalutamide
1 of 10
Pembrolizumab+Abiraterone+Prednisone
1 of 10
Pembrolizumab+Lenvatinib: AC
1 of 10
Pembrolizumab+Lenvatinib:t-NE
1 of 10
Pembrolizumab/Vibostolimab coformulation:t-NE
1 of 10
Experimental Treatment
1000 Total Participants · 10 Treatment Groups
Primary Treatment: Pembrolizumab/Vibostolimab coformulation · No Placebo Group · Phase 1 & 2
Carboplatin+EtoposideExperimental Group · 2 Interventions: Etoposide, Carboplatin · Intervention Types: Drug, Drug
Pembrolizumab+Carboplatin+EtoposideExperimental Group · 3 Interventions: Etoposide, Pembrolizumab 200 mg, Carboplatin · Intervention Types: Drug, Biological, Drug
Pembrolizumab/Vibostolimab coformulation
Biological
Experimental Group · 1 Intervention: Pembrolizumab/Vibostolimab coformulation · Intervention Types: BiologicalPembrolizumab+OlaparibExperimental Group · 3 Interventions: Olaparib 400 mg, Pembrolizumab 200 mg, Olaparib 300 mg · Intervention Types: Drug, Biological, Drug
Pembrolizumab+Docetaxel+PrednisoneExperimental Group · 4 Interventions: Pembrolizumab 200 mg, Prednisone 5 mg, Dexamethasone 8 mg, Docetaxel 75 mg/m^2 · Intervention Types: Biological, Drug, Other, Drug
Pembrolizumab+EnzalutamideExperimental Group · 2 Interventions: Pembrolizumab 200 mg, Enzalutamide 160 mg · Intervention Types: Biological, Drug
Pembrolizumab+Abiraterone+PrednisoneExperimental Group · 3 Interventions: Abiraterone acetate 1000 mg, Pembrolizumab 200 mg, Prednisone 5 mg · Intervention Types: Drug, Biological, Drug
Pembrolizumab+Lenvatinib: ACExperimental Group · 2 Interventions: Pembrolizumab 200 mg, Lenvatinib · Intervention Types: Biological, Drug
Pembrolizumab+Lenvatinib:t-NEExperimental Group · 2 Interventions: Pembrolizumab 200 mg, Lenvatinib · Intervention Types: Biological, Drug
Pembrolizumab/Vibostolimab coformulation:t-NE
Biological
Experimental Group · 1 Intervention: Pembrolizumab/Vibostolimab coformulation · Intervention Types: BiologicalTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
FDA approved
Pembrolizumab
FDA approved
Prednisone
FDA approved
Lenvatinib
FDA approved
Carboplatin
FDA approved
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed every 3 weeks over the duration of the study which is estimated to be approximately 2 years
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,653 Previous Clinical Trials
4,952,637 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,578,204 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,618 Previous Clinical Trials
7,935,825 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Male Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have metastatic prostate cancer defined by ≥1% neuroendocrine cells that are located in discrete regions of a recent biopsy specimen from a metastasis as determined by the investigational site and confirmed by central histology review prior to enrollment.
Treatment with androgen deprivation therapy (ADT) must have been initiated ≥4 weeks prior to first dose of study therapy and must be continued throughout the study
Cohort A: Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ≥4 weeks have elapsed from the last dose of docetaxel prior to day 1 of Cycle 1.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Yu, Evan Y., Michael P. Kolinsky, William R. Berry, Margitta Retz, Loic Mourey, Josep M. Piulats, Leonard J. Appleman, et al.. 2022. “Pembrolizumab Plus Docetaxel and Prednisone in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort B Study”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2022.02.023.
- Yu, Evan Y., Michael P. Kolinsky, William R. Berry, Margitta Retz, Loic Mourey, Josep M. Piulats, Leonard J. Appleman, et al.. 2022. “Pembrolizumab Plus Docetaxel and Prednisone in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort B Study”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2022.02.023.
- Yu EY, Kolinsky MP, Berry WR, Retz M, Mourey L, Piulats JM, Appleman LJ, Romano E, Gravis G, Gurney H, Bogemann M, Emmenegger U, Joshua AM, Linch M, Sridhar S, Conter HJ, Laguerre B, Massard C, Li XT, Schloss C, Poehlein CH, de Bono JS. Pembrolizumab Plus Docetaxel and Prednisone in Patients with Metastatic Castration-resistant Prostate Cancer: Long-term Results from the Phase 1b/2 KEYNOTE-365 Cohort B Study. Eur Urol. 2022 Jul;82(1):22-30. doi: 10.1016/j.eururo.2022.02.023. Epub 2022 Apr 6.
- 2016. "Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02861573.
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