A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)

Description

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.

Conditions

Bladder Cancer

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Study Overview

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Study Details

Study overview

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.

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

A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)

Condition
Bladder Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro, Los Angeles, California, United States, 90095

Orlando

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102), Orlando, Florida, United States, 32804

Chicago

University of Chicago Medical Center ( Site 0109), Chicago, Illinois, United States, 60637

Iowa City

University of Iowa ( Site 0110), Iowa City, Iowa, United States, 52242

New York

Icahn School of Medicine at Mount Sinai ( Site 0101), New York, New York, United States, 10029

Durham

Duke Cancer Institute ( Site 0107), Durham, North Carolina, United States, 27710

Cleveland

Cleveland Clinic Main ( Site 0100), Cleveland, Ohio, United States, 44195

Philadelphia

Fox Chase Cancer Center ( Site 0106), Philadelphia, Pennsylvania, United States, 19111

Dallas

UT Southwestern Medical Center ( Site 0103), Dallas, Texas, United States, 75390

Houston

Houston Methodist Hospital-Department of Urology ( Site 0111), Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * 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
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2031-10-20