RECRUITING

A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder. The standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goals of this study are to learn: * If people who receive intismeran autogene with BCG live longer without the cancer growing, spreading, or coming back, or dying from any cause, compared to people who receive BCG alone * If more people who receive intismeran autogene with BCG have their cancer go away (complete response), compared to people who receive BCG alone * How many people who receive intismeran autogene without BCG have their cancer go away

Official Title

A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)

Quick Facts

Study Start:2025-03-11
Study Completion:2031-09-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06833073

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder
  2. * Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG
  3. * Has CIS +/-papillary non-muscle invasive UC of the bladder
  4. * Is ineligible for, or refusing, any IVESIC therapy
  5. * Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG
  6. * Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)
  1. * Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC
  2. * Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions
  3. * Has a known additional malignancy that is progressing or has required active treatment within the last 3 years
  4. * Has had a myocardial infarction within 6 months of randomization/allocation
  5. * Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation
  6. * Has received prior treatment with a cancer vaccine
  7. * Has immunodeficiency or is receiving chronic systemic steroid therapy
  8. * Has active autoimmune disease that has required systemic treatment in the last 2 years
  9. * Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU)
  10. * Has current active tuberculosis
  11. * Has a known history of HIV infection

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Michael G Oefelein Clinical Trials ( Site 0138)
Bakersfield, California, 93301
United States
Los Alamitos Hematology Oncology Medical Group ( Site 0141)
Los Alamitos, California, 90720
United States
Genesis Healthcare-Torrance ( Site 0140)
Torrance, California, 90503
United States
Genesis Research LLC ( Site 0118)
Torrance, California, 90505
United States
Urological Research Network ( Site 0133)
Hialeah, Florida, 33016
United States
University of Missouri Health Care ( Site 0126)
Columbia, Missouri, 65212
United States
NHO Revive Research Institute, LLC ( Site 0137)
Lincoln, Nebraska, 68506
United States
OHSU Knight Cancer Institute - South Waterfront ( Site 0110)
Portland, Oregon, 97239
United States
Urology Austin, PLLC ( Site 0109)
Austin, Texas, 78759
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-11
Study Completion Date2031-09-03

Study Record Updates

Study Start Date2025-03-11
Study Completion Date2031-09-03

Terms related to this study

Additional Relevant MeSH Terms

  • Urinary Bladder Neoplasms
  • Non-Muscle Invasive Bladder Neoplasms
  • Carcinoma in Situ