Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around

Description

Summary

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

Official Title

A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab With Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants With High-risk Stage II-IV Melanoma (KEYVIBE-010)

Keywords

Melanoma, Programmed Cell Death-1 (PD1, PD-1), T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), Pembrolizumab, Pembrolizumab/Vibostolimab

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 0131) accepting new patients
    Los Angeles California 90095 United States
  • UCSF Medical Center at Mission Bay ( Site 0130) accepting new patients
    San Francisco California 94158 United States
  • The Angeles Clinic and Research Institute - West Los Angeles Office ( Site 0123) accepting new patients
    Los Angeles California 90025 United States
  • California Pacific Medical Center - Pacific Campus ( Site 0111) accepting new patients
    San Francisco California 94115 United States
  • Moores Cancer Center ( Site 0116) accepting new patients
    La Jolla California 92093-0698 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT05665595
Phase
Phase 3 Skin Cancer/Melanoma Research Study
Study Type
Interventional
Participants
Expecting 1560 study participants
Last Updated