A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
Running, not enrolling · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Bladder Cancer
In brief
Researchers are looking for new ways to treat people with high-risk muscle-invasive urothelial carcinoma (MIUC). Urothelial carcinoma is a type of bladder cancer that begins in cells that line the inside of the bladder and other parts of the urinary tract, such as part of the kidneys, ureters, and urethra. People with MIUC usually have chemotherapy before surgery, then surgery to remove the cancer. Chemotherapy is a type of medicine to destroy cancer cells or stop them from growing. After surgery, some people receive more treatment to prevent cancer from returning. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Enfortumab vedotin (EV) is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to learn if giving intismeran autogene (the study treatment) with pembrolizumab can prevent MIUC from returning after surgery. Intismeran autogene (also called mRNA-4157) is designed to treat each person's cancer by helping the person's immune system identify and kill cancer cells based on certain proteins found on those cancer cells. The goals of this study are to learn if people who receive intismeran autogene and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab, and to learn about the safety of intismeran autogene, pembrolizumab, and EV, and if people tolerate them.
Key facts
- Study ID
- NCT06305767
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 230
- Starts
- 2024-03-28
- Expected to finish
- 2031-10-20
- Last updated by the study team
- 2026-01-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The main inclusion criteria include but are not limited to the following:
- Has a histological diagnosis of urothelial carcinoma (UC)
- 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 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
- 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
You may not qualify if…
- 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 it is running
- AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102) — Orlando, Florida, United States
- University of Chicago Medical Center ( Site 0109) — Chicago, Illinois, United States
- University of Iowa ( Site 0110) — Iowa City, Iowa, United States
- Icahn School of Medicine at Mount Sinai ( Site 0101) — New York, New York, United States
- Duke Cancer Institute ( Site 0107) — Durham, North Carolina, United States
- Cleveland Clinic Main ( Site 0100) — Cleveland, Ohio, United States
- Fox Chase Cancer Center ( Site 0106) — Philadelphia, Pennsylvania, United States
- UT Southwestern Medical Center ( Site 0103) — Dallas, Texas, United States
- Houston Methodist Hospital-Department of Urology ( Site 0111) — Houston, Texas, United States
- Macquarie University-MQ Health Clinical Trials Unit ( Site 1803) — Macquarie University, New South Wales, Australia
- Westmead Hospital ( Site 1802) — Westmead, New South Wales, Australia
- Mater Misericordiae Limited ( Site 1808) — South Brisbane, Queensland, Australia
- One Clinical Research ( Site 1807) — Nedlands, Western Australia, Australia
- BC Cancer Vancouver ( Site 0004) — Vancouver, British Columbia, Canada
- Princess Margaret Cancer Centre ( Site 0003) — Toronto, Ontario, Canada
- Centre Hospitalier de l'Université de Montréal ( Site 0005) — Montreal, Quebec, Canada
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0001) — Québec, Quebec, Canada
- Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002) — Sherbrooke, Quebec, Canada
- CIDO SpA ( Site 1509) — Temuco, Araucania, Chile
- Bradfordhill-Clinical Area ( Site 1501) — Recoleta, Santiago, Region M. de Santiago, Chile
- FALP ( Site 1500) — Santiago, Region M. de Santiago, Chile
- Pontificia Universidad Catolica de Chile ( Site 1503) — Santiago, Region M. de Santiago, Chile
- ONCOCENTRO APYS-ACEREY ( Site 1506) — Viña del Mar, Valparaiso, Chile
- Clínica Universitaria Colombia ( Site 1600) — Bogotá, Bogota D.C., Colombia
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104) — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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