A clinical study of V940 and BCG in people with bladder cancer (V940-011)

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

5 Jun 2025 → ongoing

Decision date (initial)

2025-04-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC · Moderna

External identifiers

EU CT number

2024-517335-46-00

WHO UTN

U1111-1312-0572

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Pharmacodynamic, Safety, Therapy

Cohort A: To compare V940 in combination with BCG to BCG monotherapy with respect to EFS

Secondary objectives 5

1. Cohort A: To evaluate V940 in combination with BCG and BCG monotherapy with respect to: 12-month EFS rate, 24-month EFS rate
2. Cohort A: To evaluate V940 in combination with BCG and BCG monotherapy with respect to: RFS, DSS, OS, 12-month OS rate, 24-month OS rate
3. Cohort A: To evaluate V940 in combination with BCG and BCG monotherapy in participants with CIS at baseline with respect to: CRR, DOR
4. Cohort A: To evaluate V940 in combination with BCG and BCG monotherapy with respect to time to cystectomy
5. Cohort A: To evaluate the safety of all treatment arms

Conditions and MedDRA coding

Bladder cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before randomization/allocation and showed centrally-confirmed high-risk non-muscle invasive bladder cancer (NMIBC)
2. Cohort A: Is BCG-naïve defined as either having never received Bacillus Calmette–Guérin (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. Cohort B: Is either BCG-naïve (as defined above) or BCG-exposed who did not receive adequate dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG
4. Is an individual who can provide a tumor tissue sample that is suitable for the NGS and provide blood samples as specified in the study
5. Is an individual with a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 56 days before randomization/allocation
6. Cohort B only: Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)
7. Individuals who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization/allocation

Exclusion criteria 17

1. Has a history of or concurrent locally-advanced or metastatic urothelial carcinoma (UC)
2. Has concurrent extravesical non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years
3. Has a known additional malignancy that is progressing or has required active treatment within the last 3 years
4. Had a myocardial infarction within 6 months of randomization/allocation
5. Cohort A only: Has a known history of HIV infection
6. Cohort B only: Is HIV-infected individual with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
7. Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation
8. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
9. Has received prior treatment with a cancer vaccine
10. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization/allocation
11. Active autoimmune disease that has required systemic treatment in the last 2 years
12. Active infection and/or diagnosis requiring systemic therapy at the time of randomization/allocation
13. Cohort A only: Has a history of a hypersensitivity reaction to V940 and/or BCG and/or any of their excipients. Cohort B only: Has a history of a hypersensitivity reaction to V940 and/or any of its excipients
14. Has not adequately recovered from major surgery or has ongoing surgical complications
15. Is incapacitated
16. Cohort A only: Has one or more of the following contraindications to BCG: prior BCG sepsis or systemic infection, total bladder incontinence, or an adverse experience to a previous BCG instillation that resulted in treatment discontinuation and precludes retreating with BCG
17. Cohort A only: Has current active tuberculosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Cohort A: Event-Free Survival (EFS)

Secondary endpoints 12

1. Cohort A: 12-month EFS Rate
2. Cohort A: 24-month EFS Rate
3. Cohort A: Recurrence-Free Survival (RFS)
4. Cohort A: Disease-Specific Survival (DSS)
5. Cohort A: Overall Survival (OS)
6. Cohort A: 12-month OS Rate
7. Cohort A: 24-month OS Rate
8. Cohort A: Complete Response Rate (CRR)
9. Cohort A: Duration of Response (DOR)
10. Cohort A: Time to Cystectomy
11. Cohort A: Number of Participants who Experience an Adverse Event (AE)
12. Cohort A: Number of Participants Who Discontinue Study Treatment Due to an AE

Investigational products

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

Test 1

Comparator 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 6

Locations

9 EU/EEA countries · 35 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 52 files

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

Application history

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