A Phase 1/2 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma (MIUC) (INTerpath-005)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505658-17-00

Acronym

V940-005

Enrollment

Registered

2024-03-28

Start date

2024-04-16

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle-invasive Urothelial Carcinoma

Brief summary

Adjuvant Cohort: Disease-Free Survival (DFS), Perioperative Cohort: Number of Participants Who Experience an Adverse Event (AE), Perioperative Cohort: Number of Participants Who Discontinue Study Treatment Due to AE

Detailed description

Adjuvant Cohort: Overall-Survival (OS), Adjuvant Cohort: Distant Metastasis-Free Survival (DMFS), Adjuvant Cohort: Number of Participants Who Experience an AE, Adjuvant Cohort: Number of Participants Who Discontinue Study Treatment Due to an AE, Perioperative Cohort: Pathologic Complete Response (pCR) Rate, Perioperative Cohort: Pathologic Downstaging (pDS) Rate

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGmRNA-4157

DRUGENFORTUMAB VEDOTIN

DRUGPlacebo to V940

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Adjuvant Cohort: Disease-Free Survival (DFS), Perioperative Cohort: Number of Participants Who Experience an Adverse Event (AE), Perioperative Cohort: Number of Participants Who Discontinue Study Treatment Due to AE	—

Secondary

Measure	Time frame
Adjuvant Cohort: Overall-Survival (OS), Adjuvant Cohort: Distant Metastasis-Free Survival (DMFS), Adjuvant Cohort: Number of Participants Who Experience an AE, Adjuvant Cohort: Number of Participants Who Discontinue Study Treatment Due to an AE, Perioperative Cohort: Pathologic Complete Response (pCR) Rate, Perioperative Cohort: Pathologic Downstaging (pDS) Rate	—

Countries

France, Germany, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026