臨床研究等提出・公開システム

A Phase 3,Randomized,Double-Blind,Placebo-and Active-Comparator-Controlled Clinical study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-Risk Stage II-IV Melanoma (INTerpath-001)

Phase 3 Study of Adjuvant V940 and Pembrolizumab in Resected Melanoma

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Not Recruiting

May. 17, 2024

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

- 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)

- 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

Both

Malignant Melanoma

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.

Recurrence-Free Survival (RFS)

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

May. 21, 2024

Yes

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

United States/Canada/Argentina/Brazil/Chile/Colombia/Mexico/Belgium/Denmark/France/Germany/Greece/Israel/Italy/Poland/Portugal/South Africa/Spain/Sweden/Switzerland/Turkey/United Kingdom/Australia/New Zealand/South Korea/Taiwan