Phase 3 Study of V940 and Pembrolizumab in Resected Melanoma

Phase 1

• Conditions: Melanoma; MedDRA version: 20.0Level: LLTClassification code: 10027150Term: Melanoma malignant Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-503652-27-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-30
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1165

Inclusion Criteria

Has resected cutaneous melanoma with histological confirmed stage IIB to IV., HCV infected participants are eligible if HCV viral load is undetectable at screening., HIV-infected participants must have well controlled HIV on ART., Has not received any prior systemic therapy for their melanoma beyond surgical resection., Complete resection that rendered the participant disease-free within 13 weeks prior to the first dose of pembrolizumab., Has a formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing., Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases., All suspicious lesions amenable to biopsy should be confirmed negative for malignancy., Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1., Adequate organ function, specimens must be collected within 7 days before the start of study intervention., HBsAg positive participants have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.

Exclusion Criteria

Has ocular or mucosal melanoma., Active autoimmune disease., Pneumonitis/interstitial lung disease or a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids., Active infection requiring treatment., HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease., Known active hepatitis B or C., Has history of allogeneic tissue/solid organ transplant., Has unresectable in-transit metastases., Clinically significant heart failure., Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample., Has received prior anticancer systemic or immunotherapy or another cancer vaccine or radiotherapy before starting of study intervention., Live or live-attenuated vaccine within 30 days prior to the first dose of study intervention., Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab., Known additional malignancy that is progressing or has required active treatment within the past 3 years., History of CNS metastases and/or carcinomatous meningitis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to RFS.;Secondary Objective: To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DMFS, To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to OS., To evaluate the safety and tolerability of V940 plus pembrolizumab., To evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab with respect to mean change from baseline in global health status/QoL, physical functioning, and role functioning using the EORTC QLQ-C30.;Primary end point(s): Recurrence-Free Survival (RFS)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Distant Metastasis Free Survival (DMFS);Secondary end point(s):Overall Survival;Secondary end point(s):Number of Participants Experiencing Adverse Events (AEs);Secondary end point(s):Number of Participants Discontinuing Study Treatment Due to AEs;Secondary end point(s):Change in Score from Baseline Evaluated by: - Global Health Status/Quality of Life (QoL) score (QLQ-C30 Items 29 and 30);Secondary end point(s):Change in Score from Baseline Evaluated by: - Physical Functioning Score (QLQ-C30 Items 1 to 5);Secondary end point(s):Change in Score from Baseline Evaluated by: - Role Functioning Score (QLQ-C30 Items 6 and 7)