MK-3120 for Bladder Cancer

Recruiting at 1 trial location

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Merck Sharp & Dohme LLC

Disqualifiers: Advanced urothelial cancer, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 10 months

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MK-3120 for individuals with high-risk non-muscle invasive bladder cancer (HR NMIBC). Researchers aim to determine if MK-3120 is safe and tolerable after tumor removal. The trial targets those whose bladder cancer has not spread to the muscle and who may have previously received treatments like BCG, a common bladder cancer therapy. It may suit individuals who recently underwent bladder surgery and are managing cancer confined to the bladder's lining. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and to measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are HIV-positive or have hepatitis B, you must have well-controlled conditions on your current antiviral therapy.

Is there any evidence suggesting that MK-3120 is likely to be safe for humans?

Research has shown that MK-3120 has been tested for safety in people with various advanced cancers. In these studies, most participants tolerated MK-3120 well. Some experienced side effects, but these were usually mild or moderate. Since MK-3120 remains in the early stages of research, scientists closely monitor for any negative effects to ensure safety. This study aims to determine if MK-3120 is safe and manageable for individuals with high-risk non-muscle invasive bladder cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bladder cancer, which often involve surgery, chemotherapy, or immunotherapy, MK-3120 is an experimental drug that offers a potentially new approach. MK-3120 stands out because it is administered in a unique schedule—initially once a week and then once a month, which could improve convenience and adherence for patients. Researchers are particularly excited about MK-3120 because it might have a novel mechanism of action that specifically targets cancer cells differently than existing therapies, although the exact details are still being explored. This could lead to more effective treatments with potentially fewer side effects.

What evidence suggests that MK-3120 might be an effective treatment for bladder cancer?

Research is exploring whether MK-3120, the treatment under study in this trial, can help treat high-risk non-muscle invasive bladder cancer (HR NMIBC). This type of cancer occurs in the bladder lining and has not spread to the muscle or beyond the bladder. Studies are examining the effectiveness of MK-3120 following a common surgery called transurethral resection of the bladder tumor (TURBT). The main focus is on treatment tolerance and safety. Although the effectiveness is still under investigation, researchers hope that MK-3120 could benefit bladder cancer patients. ^{1 3 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with high-risk non-muscle invasive bladder cancer (HR NMIBC) who've had a tumor removal procedure. It's open to HIV-positive participants on stable antiretroviral therapy, and those with controlled hepatitis B or C. People must have had their last tumor resection within 12 weeks before joining the study and can be either new to BCG treatment or have experienced recurrence of HR NMIBC after previous BCG therapy.

Inclusion Criteria

My last bladder tumor surgery was within 12 weeks and confirmed high-risk non-muscle invasive bladder cancer.

I have bladder cancer and either never had BCG, had it over 2 years ago with no recurrence in 24 months, or had a recurrence 12-24 months after my last BCG dose.

I have HIV and it is well-controlled with medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-3120 once weekly for the first 6 weeks, followed by once monthly for 9 months

10 months

6 weekly visits, followed by 9 monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 months

What Are the Treatments Tested in This Trial?

Interventions

• MK-3120

Trial Overview The trial is testing MK-3120 in patients with HR NMIBC following surgery to remove bladder tumors. The aim is to evaluate the safety and tolerability of MK-3120 as a potential new treatment option for this type of bladder cancer.

How Is the Trial Designed?

Group I: MK-3120 Experimental Treatment 1 Intervention

Participants will be administered MK-3120 once weekly for the first 6 weeks, followed by once monthly for 9 months.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07222488

A Clinical Study of MK-3120 in People With Bladder ... Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT.

2. patlynk.com patlynk.com/trial/NCT07222488

Intravesical MK-3120 for High-Risk Non-Muscle Invasive Bladder ... The researchers will gather data on the safety of MK-3120, as well as its potential effectiveness ... Intravesical MK-3120 for High-Risk Non-Muscle Invasive ...

3. msdclinicaltrials.com msdclinicaltrials.com/trial/nct06818643/

A Study to Evaluate the Safety and Efficacy of MK-3120 in ... The main goal of this study is to learn about the safety of MK-3120 and if people tolerate it.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06818643

A Study to Evaluate the Safety and Efficacy of MK-3120 in ... Researchers are looking for new ways to treat people with certain advanced solid tumors. Advanced means the cancer has spread to other parts of the body and ...

5. withpower.com withpower.com/trial/zilovertamab-vedotin-for-bladder-cancer-549f3

Zilovertamab Vedotin for Bladder Cancer Our study had 85% power to detect a 20% absolute improvement in 2-yr BIDFS rate over 60% historical rate (Mak JCO 2014). Key secondary endpoints included ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/574535

A Study to Evaluate the Safety and Efficacy of MK-3120 in ... A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors

7. merckclinicaltrials.com merckclinicaltrials.com/trial/nct06818643/

A Study to Evaluate the Safety and Efficacy of MK-3120 in ... Trial Purpose. Researchers are looking for new ways to treat people with certain advanced solid tumors. Advanced means the cancer has spread to other parts of ...

8. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/574535

A Study to Evaluate the Safety and Efficacy of MK-3120 in ... A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002). Phase. I / II.