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

Moderna · Merck Sharp & Dohme LLC

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: Pharmacodynamic, Others, Safety, Efficacy, Therapy

1. Cohort A: To compare V940 in combination with BCG to BCG monotherapy with respect to EFS
2. Cohort B: To evaluate V940 monotherapy with respect to CRR

Secondary objectives 8

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 B: To evaluate V940 monotherapy with respect to: 6-month CRR, 12-month CRR, DOR
6. Cohort B: To evaluate V940 monotherapy with respect to: RFS, DSS, OS
7. Cohort B: To evaluate V940 monotherapy with respect to time to cystectomy
8. Cohorts A and B: 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 14 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. Active autoimmune disease that has required systemic treatment in the last 2 years
3. Active infection and/or diagnosis requiring systemic therapy
4. 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
5. Has not adequately recovered from major surgery or has ongoing surgical complications
6. Is incapacitated
7. 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
8. Cohort A only: Has current active tuberculosis
9. Has concurrent extravesical non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years
10. Has a known additional malignancy that is progressing or has required active treatment within the last 3 years
11. Had a myocardial infarction within 6 months of randomization/allocation
12. Cohort B only: Is HIV-infected individual with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
13. Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation
14. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
15. Has received prior treatment with a cancer vaccine
16. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization/allocation
17. Cohort A only: Has a known history of HIV infection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Cohort A: Event-Free Survival (EFS)
2. Cohort B: Complete Response Rate (CRR)

Secondary endpoints 18

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: CRR
9. Cohort A: Duration of Response (DOR)
10. Cohort A: Time to Cystectomy
11. Cohort B: 6-month CRR
12. Cohort B: 12-month CRR
13. Cohort B: RFS
14. Cohort B: DSS
15. Cohort B: OS
16. Cohort B: Time to Cystectomy
17. Number of Participants who Experience an Adverse Event (AE)
18. 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 · 36 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 50 files

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

Application history

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