V940 + BCG for Bladder Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Merck Sharp & Dohme LLC

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 V940, the study treatment, to standard treatment can help treat HR NMIBC. V940 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 V940 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 V940 with BCG have their cancer go away (complete response), compared to people who receive BCG alone * How many people who receive V940 without BCG have their cancer go away

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for individuals with high-risk non-muscle invasive bladder cancer (HR NMIBC), including carcinoma in situ (CIS). Participants must have had a recent tumor removal surgery and either never received BCG therapy or not within the last two years. People living with well-controlled HIV on treatment can join, but those who've had certain BCG treatments or refuse specific therapies cannot participate.

Inclusion Criteria

I am not eligible for or am refusing bladder instillation therapy.

I have HIV and it is well controlled with medication.

My bladder cancer is high-risk but has not invaded the muscle.

Treatment Details

Interventions

• V940 (Cancer Vaccine)

Trial Overview The study tests if adding V940 to standard BCG immunotherapy improves outcomes for HR NMIBC patients. It aims to see if this combination helps people live longer without cancer growth, spread, recurrence, or death compared to just receiving BCG. Researchers also want to know how many achieve complete cancer remission with V940 alone.

Participant Groups

Group I: V940 + BCG Experimental Treatment 2 Interventions

Participants receive 1 mg of V940 via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. Participants also receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75.

Group II: V940 Experimental Treatment 1 Intervention

Participants receive 1 mg of V940 via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses.

Group III: BCG Active Control 1 Intervention

Participants receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

ModernaTX, Inc.

Industry Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris