RECRUITING

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

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

Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder NeoplasmsCarcinoma in Situ
Talk to us

Related Conditions:

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder NeoplasmsCarcinoma in Situ

Study Overview

On this page

Study Details

Study overview

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

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)

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

Condition
Urinary Bladder Neoplasms
Intervention / Treatment

-

Contacts and Locations

Bakersfield

Michael G Oefelein Clinical Trials ( Site 0138), Bakersfield, California, United States, 93301

Los Alamitos

Los Alamitos Hematology Oncology Medical Group ( Site 0141), Los Alamitos, California, United States, 90720

Torrance

Genesis Healthcare-Torrance ( Site 0140), Torrance, California, United States, 90503

Torrance

Genesis Research LLC ( Site 0118), Torrance, California, United States, 90505

Hialeah

Urological Research Network ( Site 0133), Hialeah, Florida, United States, 33016

Columbia

University of Missouri Health Care ( Site 0126), Columbia, Missouri, United States, 65212

Lincoln

NHO Revive Research Institute, LLC ( Site 0137), Lincoln, Nebraska, United States, 68506

Portland

OHSU Knight Cancer Institute - South Waterfront ( Site 0110), Portland, Oregon, United States, 97239

Austin

Urology Austin, PLLC ( Site 0109), Austin, Texas, United States, 78759

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

  • * Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder
  • * 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
  • * Has CIS +/-papillary non-muscle invasive UC of the bladder
  • * Is ineligible for, or refusing, any IVESIC therapy
  • * 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
  • * Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)
  • * Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC
  • * 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
  • * Has a known additional malignancy that is progressing or has required active treatment within the last 3 years
  • * Has had a myocardial infarction within 6 months of randomization/allocation
  • * Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation
  • * Has received prior treatment with a cancer vaccine
  • * Has immunodeficiency or is receiving chronic systemic steroid therapy
  • * Has active autoimmune disease that has required systemic treatment in the last 2 years
  • * 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)
  • * Has current active tuberculosis
  • * Has a known history of HIV infection

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

2031-09-03