NCT05879653 is a Phase 2 clinical trial of MK-3475 in Bladder Cancer, sponsored by Kyoto University Hospital.

Who is sponsoring NCT05879653?

NCT05879653 is sponsored by Kyoto University Hospital.

What drugs are being tested in NCT05879653?

Interventions in NCT05879653: MK-3475, ASG-22CE, maximal TURBT, Radiation therapy.

What condition does NCT05879653 study?

NCT05879653 studies Bladder Cancer.

Is NCT05879653 still recruiting?

NCT05879653 is currently recruiting now. Last updated 29 August 2025.

Last reviewed 2025-08-29 · How we verify

NCT05879653

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pembrolizumab and EV With Radiation Therapy for MIBC Patients (PEVRAD)

Recruiting now Phase 2 Last updated 29 August 2025

What this trial tests

Phase 2 trial testing MK-3475 in Bladder Cancer in 30 participants. Currently enrolling.

Timeline

1 October 2023

Primary endpoint
30 September 2025

30 September 2027

Quick facts

Lead sponsor	Kyoto University Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 October 2023
Primary completion	30 September 2025
Estimated completion	30 September 2027
Sites	4 locations across Japan

Drugs / interventions tested

MK-3475 — full drug profile →
ASG-22CE — full drug profile →
maximal TURBT
Radiation therapy — full drug profile →

Conditions studied

Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Kyoto University Hospital

Who can join

18 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to assess the efficacy and safety of induction therapy with MK-3475 and ASG-22CE and radiation therapy with MK-3475 in patients with cT2-4aN0M0 muscle invasive bladder cancer who are unfit for or refuse radical cystectomy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Enfortumab vedotin and pembrolizumab: redefining the standard of care for previously untreated advanced urothelial cancer.
Sternschuss M, Rosenberg JE. · · 2025 · cited 2× · PMID 40129250 · DOI 10.1080/14796694.2025.2482363
Recent Advances and Future Directions in Bladder Preservation Therapy for Muscle-Invasive Bladder Cancer.
Kimura T, Inoue S, Sano T, Zennami K, et al · · 2025 · cited 1× · PMID 40590324 · DOI 10.1111/iju.70164

Verify or expand the search:

Other trials of MK-3475

Trials testing the same drug.

NCT05832827 — First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Art · Phase 2 · recruiting
NCT04098068 — Study of MK-3475 (Pembrolizumab) in Patients With Microsatellite Unstable (MSI) Tumors (Cohort D) · Phase 2 · completed
NCT03003468 — Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten C · Phase 1, PHASE2 · completed
NCT02852655 — A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembr · Phase 1 · active not recruiting
NCT02289209 — Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head an · Phase 2 · completed

Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) · Phase 3 · recruiting
NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer · Phase 2 · recruiting
NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05879653 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kyoto University Hospital
Last refreshed: 29 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05879653.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing