A clinical study of MK-3120 in people with bladder cancer (MK-3120-003)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

16 Mar 2026 → ongoing

Decision date (initial)

2025-12-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-520467-40-00

WHO UTN

U1111-1317-2687

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacogenetic, Efficacy, Pharmacokinetic, Pharmacogenomic, Safety, Dose response, Pharmacodynamic

To evaluate the safety and tolerability of I-VESIC MK-3120 monotherapy

Secondary objectives 1

1. To evaluate the efficacy of I-VESIC MK-3120 with respect to CRR at 3 months based on local assessment

Conditions and MedDRA coding

High-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Has histologically confirmed carcinoma in situ (CIS) +/- papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally.
2. Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before allocation and showed high-risk NMIBC histology. For individuals with papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by attainment of a visually complete resection of all papillary tumors (Ta and T1).
3. Bacillus Calmette-Guérin (BCG)-, exposed and received adequate BCG therapy and had recurrence of CIS +/- papillary high-risk NMIBC >12 months but ≤24 months after the last BCG dose.
4. Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy.
5. Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation.
6. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

Exclusion criteria 12

1. Has history of or current locally advanced (ie, T2, T3, T4) or metastatic urothelial cancer (UC).
2. Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or history of extravesical non-muscle invasive UC that recurred within the last 2 years.
3. Has active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture.
4. Has a condition that would prohibit normal voiding (or holding bladder voiding for 1 to 2 hours).
5. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
6. Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
7. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
8. Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
9. Has known active central nervous system metastases and/or carcinomatous meningitis.
10. Has active infection requiring systemic therapy.
11. Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, or has current pneumonitis/ILD.
12. Has not adequately recovered from major surgery or has ongoing surgical complications.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
2. Number of Participants Who Experience One or More Adverse Events (AEs)
3. Number of Participants Who Discontinue Study Treatment Due to AEs

Secondary endpoints 1

1. Complete Response Rate (CRR)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Nancy Davis

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Nancy Davis

Third parties 3

Locations

8 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 45 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications