Health Condition 1: C439- Malignant melanoma of skin, unspecified
Conditions
Interventions
Intervention1: MK7684A (Vibostolimab with Pembrolizumab): Dose: Vibostolimab 200 mg + Pembrolizumab 200 mg
Frequency: every 3 weeks (Q3W)
Route of Administration: intravenous (IV)
Duration: 17 Cycles
Sponsors
Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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. 2. Has not received any prior systemic therapy for melanoma beyond surgical resection. 3. Has had no more than 12 weeks between final surgical resection and randomization. 4. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART). 5. 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. 6. Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
Exclusion criteria
Exclusion criteria: 1. Has ocular, mucosal, or conjunctival melanoma 2. 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 3. Has not adequately recovered from major surgical procedure or has ongoing surgical complications 4. Has received prior radiotherapy within 2 weeks of start of study intervention or has had a history of radiation pneumonitis 5. Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed 6. Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration 7. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease 8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years 9. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis 10. Has an active autoimmune disease that has required systemic treatment in past 2 years 11. Has an active infection requiring systemic therapy 12. Has had an allogenic tissue/solid organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To compare MK-7684A to pembrolizumab with respect to RFS. • Hypothesis (H1): MK-7684A is superior to pembrolizumab with respect to RFS as assessed by investigator.Timepoint: RFS timepoint is event driven up to approximately 56 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To compare MK-7684A to pembrolizumab with respect to DMFS. • Hypothesis (H2): MK-7684A is superior to pembrolizumab with respect to DMFS as assessed by investigator.Timepoint: DMFS timepoint is event driven up to approximately 72 months.;• To compare MK-7684A to pembrolizumab with respect to OS. • Hypothesis (H3): MK-7684A is superior to pembrolizumab with respect to overall survival.Timepoint: OS: The time from randomization to death due to any cause.;To evaluate the safety and tolerability of MK-7684A and pembrolizumabTimepoint: • Adverse event • Study intervention discontinuation due to AEs;To compare MK-7684A to pembrolizumab with respect to mean change from baseline in global health status/QoL, physical functioning, and role functioning using the EORTC QLQ-C30Timepoint: • Change in score from baseline at a predefined timepoint evaluated by: o Global health status/QoL score (Items 29 and 30) o Physical functioning score (Items 1-5) • Role functioning score (Items 6 and 7) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, India, Ireland, Israel, Italy, Japan, New Zealand, Poland, Republic of Korea, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Monisha Sharma
MSD Pharmaceuticals Pvt Ltd
Outcome results
None listed