Adjuvant MK-7684A vs Pembrolizumab for Resected High-Risk Melanoma

JRCT ID: jRCT2031230099

Registered date:27/05/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Melanoma
• Date of first enrollment: 23/05/2023
• Target sample size: 20
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Colombia,Japan,France,Japan,Germany,Japan,India,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,New Zealand,Japan,Poland,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,Turkiye,Japan,USA,Japan,UK,Japan
• Study type: Interventional
• Intervention(s): MK-7684A (coformulation of MK-7684 200mg and pembrolizumab 200mg) will be administered using a 30 minute IV infusion every 3 weeks.

Outcome(s)

• Primary Outcome: Recurrence-Free Survival (RFS)

Secondary Outcome

Distant Metastasis-Free Survival (DMFS)
Overall Survival (OS)
Safety and tolerability
EORTC QLQ-30

Key inclusion & exclusion criteria

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

Include criteria

- Has surgically resected and histologically or pathologically confirmed diagnosis of Stage IIB and IIC (pathological or clinical), III, or IV cutaneous melanoma per the American Joint Committee on Cancer (AJCC) eighth edition guidelines
- Has not received any prior systemic therapy for melanoma beyond surgical resection
- Has had no more than 12 weeks between final surgical resection and randomization
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
- Participants 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
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclude criteria

- Has ocular, mucosal, or conjunctival melanoma
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has not adequately recovered from major surgical procedure or has ongoing surgical complications
- Has received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitis
- Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has an active infection requiring systemic therapy
- Has had an allogenic tissue/solid organ transplant

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT05665595