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New treatment for bladder cancer using intismeran autogene and pembrolizumab

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

Phase1; Phase2 Interventional Merck Sharp & Dohme LLC · NCT06305767

This study is testing a new treatment combining intismeran autogene and pembrolizumab to see if it can help prevent bladder cancer from coming back in patients with high-risk muscle-invasive urothelial carcinoma after surgery.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment230 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionspembrolizumab, chemotherapy, radiation, Enfortumab, immunotherapy
Locations72 sites (Los Angeles, California and 71 other locations)
Trial IDNCT06305767 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of intismeran autogene combined with pembrolizumab in treating high-risk muscle-invasive urothelial carcinoma (MIUC) in patients. The study aims to determine if this combination can prevent cancer recurrence after surgery. Participants will undergo chemotherapy prior to surgery, followed by the experimental treatment to enhance their immune response against cancer cells. The trial includes both a perioperative and an adjuvant cohort to assess different stages of treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with high-risk muscle-invasive urothelial carcinoma who are eligible for radical cystectomy and pelvic lymphadenectomy.

Not a fit: Patients with non-urothelial carcinoma or those who have already received effective treatment for their bladder cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of bladder cancer recurrence in high-risk patients.

How similar studies have performed: Other studies have shown promise with immunotherapy approaches in bladder cancer, indicating potential for success with this novel combination.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Must provide blood samples per protocol, to enable intismeran autogene production, and circulating tumor deoxyribonucleic acid testing
* Has an Eastern Cooperative Oncology Group performance status of 0 to 2 assessed within 7 days before randomization
* Must provide a formalin-fixed paraffin-embedded tumor tissue sample for next generation sequencing

Adjuvant Cohort:

* Has MIUC
* Has dominant histology of urothelial carcinoma (UC)
* Has high-risk pathologic disease after radical resection
* For participants who have not received cisplatin-based neoadjuvant chemotherapy, are ineligible to receive cisplatin according to protocol pre-defined criteria

Perioperative Cohort:

* Has MIBC
* Has a histological diagnosis of UC
* Is deemed eligible for RC and PLND and agrees to undergo curative intent standard RC and PLND and neoadjuvant and adjuvant treatment per protocol
* Is ineligible to receive cisplatin according to protocol pre-defined criteria

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has known additional malignancy that is progressing or has required active treatment ≤3 years prior to study randomization
* Has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy
* Has active hepatitis B and hepatitis C virus infection

Adjuvant Cohort:

* Has received prior systemic anticancer therapy
* Has received prior neoadjuvant therapy, with the exception of neoadjuvant cisplatin-based chemotherapy for MIUC
* Has severe hypersensitivity to either intismeran autogene or pembrolizumab (MK-3475) and/or any of their excipients

Perioperative Cohort:

* Has received any prior systemic treatment, cancer vaccine treatment, chemoradiation, and/or radiation therapy treatment for MIBC
* Has severe hypersensitivity to either intismeran autogene, pembrolizumab, or EV and/or any of their excipients
* Has ongoing sensory or motor neuropathy
* Has active keratitis or corneal ulcerations

Where this trial is running

Los Angeles, California and 71 other locations

+22 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bladder CancerProgrammed Cell Death-1Programmed Cell Death 1 Ligand 1Programmed Cell Death 1 Ligand 2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.