Phase 3 Study of Adjuvant V940 and Pembrolizumab in Resected Melanoma

JRCT ID: jRCT2041230169

Registered date:13/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant Melanoma
• Date of first enrollment: 04/06/2024
• Target sample size: 10
• Countries of recruitment: United States,Japan,Canada,Japan,Argentina,Japan,Brazil,Japan,Chile,Japan,Colombia,Japan,Mexico,Japan,Belgium,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,Poland,Japan,Portugal,Japan,South Africa,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Turkey,Japan,United Kingdom,Japan,Australia,Japan,New Zealand,Japan,South Korea,Japan,Taiwan,Japan
• Study type: Interventional
• Intervention(s): Participants receive up to 9 doses of V940 or placebo via an intramuscular (IM) injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.

Outcome(s)

• Primary Outcome: Recurrence-Free Survival (RFS)

Secondary Outcome

Distant Metastasis-Free Survival (DMFS)
Overall Survival (OS)
Safety and tolerability
EORTC QLQ-C30

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
- Has not received any prior systemic therapy for their melanoma beyond surgical resection
- No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab
- Is disease free at the time of providing documented consent for the study
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)

Exclude criteria

- Has ocular or mucosal melanoma
- Has cancer that has spread to other parts of the body and cannot be removed with surgery
- Has heart failure within the past 6 months
- Has received prior cancer therapy or another cancer vaccine
- Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years
- Has severe reaction to study medications or any of their substance used to prepare a drug
- Have not recovered from major surgery or have ongoing surgical complications

Related Information

• Primary Sponsor: Fujita Tomoko
• Secondary ID(s): NCT05933577