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Pembrolizumab/vibostolimab coformulation

BIOLOGICAL5 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

Bladder CancerHematological MalignanciesMetastatic Castration-Resistant Prostate CancerMetastatic Non Small Cell Lung CancerNeoplasms

Phase 1

Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)
RecruitingNCT02861573
Merck Sharp & Dohme LLCMetastatic Castration-Resistant Prostate Cancer
Start: 2016-11-17End: 2028-07-24Target: 1200Updated: 2026-02-17
Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) ( KEYVIBE-001)
CompletedNCT02964013
Merck Sharp & Dohme LLCNeoplasms
Start: 2016-12-13End: 2024-07-24Updated: 2025-10-14

Phase 2

Study of Pembrolizumab (MK-3475) and Pembrolizumab With Other Investigational Agents in Participants With High Risk Non-muscle Invasive Bladder Cancer (MK-3475-057/KEYNOTE-057)
CompletedNCT02625961
Merck Sharp & Dohme LLCBladder Cancer
Start: 2016-02-10End: 2025-11-05Updated: 2025-11-21
Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)
CompletedNCT04725188
Merck Sharp & Dohme LLCMetastatic Non Small Cell Lung Cancer
Start: 2021-04-20End: 2024-10-17Updated: 2025-08-15
A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
CompletedNCT05005442
Merck Sharp & Dohme LLCHematological Malignancies
Start: 2021-09-28End: 2024-12-10Updated: 2026-02-19

Related Papers

Vibostolimab Coformulated with Pembrolizumab in Participants with Docetaxel-pretreated Metastatic Castration-resistant Prostate Cancer: KEYNOTE-365 Cohort G.
2025-08-11
Phase 1b/2 KEYNOTE-365 cohort I: Pembrolizumab (pembro) plus carboplatin and etoposide chemotherapy (chemo) or chemo alone for metastatic neuroendocrine prostate cancer (NEPC).
Journal of Clinical Oncology2025-05-281 citations
PD-1 blockade plus cisplatin-based chemotherapy in patients with small cell/neuroendocrine bladder and prostate cancers
Cell Reports Medicine2024-11-016 citations
Pembrolizumab plus Abiraterone Acetate and Prednisone in Patients with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Results from KEYNOTE-365 Cohort D.
2024-06-253 citations
Cost effectiveness analysis of nadofaragene firadenovec for the treatment of high-risk, bacillus Calmette-Guerin–unresponsive, non-muscle invasive bladder cancer from a US third-party payer perspective.
Journal of Clinical Oncology2024-06-01
Outcomes of patients with bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer who demonstrated nonresponse to pembrolizumab in KEYNOTE-057: A post hoc analysis.
Journal of Clinical Oncology2024-06-01
Pembrolizumab monotherapy for high-risk non-muscle-invasive bladder cancer without carcinoma in situ and unresponsive to BCG (KEYNOTE-057): a single-arm, multicentre, phase 2 trial.
2024-05-1049 citations
A phase 2 study of AZD4635 in combination with durvalumab or oleclumab in patients with metastatic castration-resistant prostate cancer.
2024-03-029 citations
Phase 3 KEYNOTE-676 cohort A: Bacillus Calmette-Guérin (BCG) with or without pembrolizumab for high-risk (HR) non–muscle-invasive bladder cancer (NMIBC) that persists/recurs after BCG induction.
Journal of Clinical Oncology2024-01-293 citations
Phase 1b/2 study of pembrolizumab plus belzutifan and belzutifan alone in patients with docetaxel-treated metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-365 cohort J.
Journal of Clinical Oncology2024-01-292 citations
Pembrolizumab (pembro) plus lenvatinib (lenva) in patients (pts) with docetaxel-pretreated, metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-365 cohort E.
Journal of Clinical Oncology2024-01-291 citations
Pembrolizumab with favezelimab or vibostolimab for patients with bacillus Calmette-Guérin (BCG)–unresponsive high-risk (HR) non–muscle-invasive bladder cancer (NMIBC): Phase 2 KEYNOTE-057 cohort C.
Journal of Clinical Oncology2024-01-291 citations
Phase 1b/2 study of pembrolizumab (pembro) plus platinum/etoposide and platinum/etoposide for neuroendocrine metastatic prostate cancer (NEPC): KEYNOTE-365 cohort I.
Journal of Clinical Oncology2024-01-29
Coformulation of pembrolizumab and vibostolimab in patients (pts) with docetaxel-pretreated metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-365 cohort G.
Journal of Clinical Oncology2024-01-29
Bladder sparing by short-course radiotherapy combined with toripalimab in high-risk/extremely high-risk non-muscle invasive bladder cancer (HOPE-04): study protocol for a single-arm, prospective, phase II trial
BMJ Open2024-01-012 citations
Pembrolizumab and Enzalutamide in Patients with Abiraterone Acetate–Pretreated Metastatic Castration-Resistant Prostate Cancer: Cohort C of the Phase 1b/2 KEYNOTE-365 Study
European Urology Oncology2023-11-0710 citations
Role of Next Generation Immune Checkpoint Inhibitor (ICI) Therapy in Philadelphia Negative Classic Myeloproliferative Neoplasm (MPN): Review of the Literature.
2023-08-075 citations
LBA03-08 PEMBROLIZUMAB (PEMBRO) FOR PATIENTS (PTS) WITH HIGH-RISK NON-MUSCLE-INVASIVE BLADDER CANCER (HR NMIBC) UNRESPONSIVE TO BACILLUS CALMETTE-GUERIN (BCG): EFFICACY AND EVALUATION OF SUBSEQUENT CYSTECTOMY FROM COHORT B OF THE PHASE 2 KEYNOTE-057 STUDY
The Journal of Urology2023-03-23
MP63-05 OUTCOMES IN PATIENTS (PTS) WITH BACILLUS CALMETTE-GUERIN (BCG)-UNRESPONSIVE HIGH-RISK (HR) NON-MUSCLE-INVASIVE BLADDER CANCER (NMIBC) WHO UNDERWENT RADICAL CYSTECTOMY (RC) FOLLOWING PEMBROLIZUMAB (PEMBRO) TREATMENT IN KEYNOTE-057 COHORT A
The Journal of Urology2023-03-23
Pembrolizumab (pembro) monotherapy for patients (pts) with high-risk non–muscle-invasive bladder cancer (HR NMIBC) unresponsive to bacillus Calmette–Guérin (BCG): Results from cohort B of the phase 2 KEYNOTE-057 trial.
Journal of Clinical Oncology2023-02-2013 citations

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