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RecruitingLast updated: 2 February 2024

Keyvibe-010: This study testing whether combination immunotherapy and targeted therapy (pembrolizumab + vibostolimab) is more effective than immunotherapy alone (pembrolizumab) at preventing cancer recurrence in people high-risk melanoma who have had their cancer removedA 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)

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental or Active Comparator Arms. In the Experimental Arm, participants will receive a co-formulation of 200mg pembrolizumab and 200mg vibostolimab administered as an intravenous infusion on Day 1 of each 3 week cycle for up to 17 cycles. In the Active Comparator Arm, participants will receive pembrolizumab alone (adults will receive 200mg and adolescent participants weigh less than 40kg will receive 2/mg/kg up to a maximum of 200mg) administered as an intravenous infusion on Day 1 of each 3 week cycle for up to 17 cycles.

Conditions

This trial is treating patients with high-risk resected Stage IIB, IIC, III and IV melanoma.

Cancer

Skin Cancers Skin

Age

People12+

Phase

III

Trial Acronym

Keyvibe-010

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Merck Sharp & Dohme LLC

Scientific 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)

Eligibility

Inclusion

  • 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

Exclusion

  • 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

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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