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JOURNAL ONKOLOGIE – STUDIE

A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)

Rekrutierend

NCT-Nummer:
NCT06305767

Studienbeginn:
März 2024

Letztes Update:
08.08.2024

Wirkstoff:
Pembrolizumab, V940

Indikation (Clinical Trials):
Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Merck Sharp & Dohme LLC

Collaborator:
ModernaTX, Inc.

Studienleiter

Medical Director
Study Director
Merck Sharp & Dohme LLC

Kontakt

Studienlocations
(3 von 41)

klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
81675 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 498941402522» Ansprechpartner anzeigen
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405)
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +49 351 458 4425» Ansprechpartner anzeigen
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102)
32804 Orlando
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 205-520-6512» Ansprechpartner anzeigen
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
G1J 1Z4 Quebec City
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 4185254444» Ansprechpartner anzeigen
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer
J1H 5H3 Sherbrooke
CanadaRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 819-346-1110 ext. 13446» Ansprechpartner anzeigen
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0502)
20133 Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 0390372405242» Ansprechpartner anzeigen
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801)
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 48501446778» Ansprechpartner anzeigen
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0805)
WLK 61-731 Poznan
PolandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 607075929» Ansprechpartner anzeigen
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0802)
75-581 Koszalin
PolandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 943488930» Ansprechpartner anzeigen
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1302)
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 020 7822 8498» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to assess the safety and efficacy of V940 in combination

with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for

participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after

radical resection. The primary study hypothesis is that V940 in combination with

pembrolizumab results in a superior disease-free survival (DFS) as assessed by the

investigator compared to pembrolizumab alone in participants with high-risk MIUC after

radical resection.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Has muscle-invasive urothelial carcinoma (MIUC)

- Has dominant histology of UC

- Has high-risk pathologic disease after radical resection

- Must provide formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next

generation sequencing (NGS)

- Must provide blood samples per protocol, to enable V940 production, and circulating

tumor Deoxyribonucleic acid (ctDNA) testing

- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

assessed within 7 days before randomization

Exclusion Criteria:

- Has received prior systemic anticancer therapy

- Has received a live or live-attenuated vaccine within 30 days before the first dose

of study intervention

- Has known additional malignancy that is progressing or has required active treatment

<3 years prior to study randomization

- Has severe hypersensitivity to either V940 or pembrolizumab and/or any of their

excipients

- Has current pneumonitis/interstitial lung disease

- Has active infection requiring systemic therapy

- Has active hepatitis B and hepatitis C virus infection

Studien-Rationale

Primary outcome:

1. Disease Free Survival (DFS) (Time Frame - Up to approximately 28 months):
DFS is defined as the time from randomization until death from any cause, or presence of disease per investigator assessment with muscle-invasive (≥pT2) disease in the urothelial tract (upper tract or lower tract) or high grade T1 disease in the upper tract on imaging and biopsy, and/or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy. DFS will be reported for each arm.



Secondary outcome:

1. Overall Survival (OS) (Time Frame - Up to approximately 28 months):
Overall survival is defined as the time from randomization to death due to any cause. OS will be reported for each arm.

2. Distant Metastasis-Free Survival (DMFS) (Time Frame - Up to approximately 28 months):
DMFS is defined as the time from randomization until death from any cause, or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy, per investigator assessment. DMFS will be reported for each arm.

3. Number of Participants Who Experience an Adverse Event (AE) (Time Frame - Up to approximately 16 months):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience AEs will be reported for each arm.

4. Number of Participants Who Discontinue Study Treatment Due to an AE (Time Frame - Up to approximately 13 months):
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an adverse event will be presented. The number of participants who discontinue study treatment due to an AE will be reported for each arm.

Studien-Arme

  • Experimental: Pembrolizumab + V940
    Participants receive 400 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of every 6-week cycle for up to 9 cycles, plus 1 mg of V940 via intramuscular (IM) injection once available every 3 weeks up to a total of 9 doses. V940 doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.
  • Active Comparator: Pembrolizumab + Placebo
    Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle for up to 9 cycles. Placebo will be administered every 3 weeks up to a total of 9 doses. The total duration of treatment is up to approximately 13 months.

Geprüfte Regime

  • Pembrolizumab (MK-3475 / Keytruda® / ):
    Administered via IV infusion at a dose of 400 mg on Day 1 of every 6-week cycle (Q6W) for up to 9 cycles.
  • V940:
    Administered via IM injection at a dose of 1 mg every 3 weeks (Q3W) for up to 9 doses.
  • Placebo:
    V940 diluent only (saline and/or dextrose) administered via IM injection Q3W for up to 9 doses.

Quelle: ClinicalTrials.gov


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