A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma.

Trial status:Study Complete
Trial ID:
GO40558
NCT ID:
NCT03815058
EudraCT ID:
2018-001773-24
EU Trial (CTIS) Number:
2023-507389-15-00
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
Genentech, Inc.
Study Complete

Trial Details

This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of autogene cevumeran (RO7198457) plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.

Medical Condition
  • Skin Cancer
    • Trial Drug
  • Autogene cevumeran
    • See more
  • Pembrolizumab
    • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    131
    Estimated Trial Date
    Jan 2019 - Jan 2025

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    Inclusion criteria

      Inclusion Criteria:

    • Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma;
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
    • Life expectancy \>/= 12 weeks;
    • Adequate hematologic and end-organ function;
    • Naive to prior systemic anti-cancer therapy for advanced melanoma with some exceptions;
    • Tumor specimen availability;
    • Measurable disease per RECIST v1.1.

      • Exclusion criteria:

    • Ocular/uveal melanoma;
    • Any anti-cancer therapy with the exceptions as specified in the protocol;
    • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;
    • Previous splenectomy;
    • History of autoimmune disease;
    • Prior allogeneic bone marrow transplantation or prior solid organ transplantation;
    • Positive test for Human Immunodeficiency Virus (HIV) infection;
    • Active hepatitis B or C or tuberculosis;
    • Significant cardiovascular disease;
    • Known clinically significant liver disease.

    Trial Locations

    Location
    Status
    Location
    City of Hope Comprehensive Cancer Center
    Duarte, California, United States, 91010
    Status
    Location
    University of California San Diego Moores Cancer Center
    La Jolla, California, United States, 92037
    Status
    Location
    UCSF Comprehensive Cancer Ctr
    San Francisco, California, United States, 94115
    Status
    Location
    University of Colorado
    Denver, Colorado, United States, 80262
    Status
    Location
    Cancer Specialists
    Jacksonville, Florida, United States, 32256
    Status
    Location
    Moffitt McKinley Outpatient Center
    Tampa, Florida, United States, 33612
    Status
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