A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.

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.

  • Cancer
  • Skin Cancer
  • Melanoma
  • Advanced Melanoma
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Countries
  • Australia
  • Belgium
  • Germany
  • Spain
  • United Kingdom
  • United States
Study Identifier:

NCT03815058 2018-001773-24 2023-507389-15-00 GO40558

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study Summary

      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.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT03815058, GO40558, 2018-001773-24,2023-507389-15-00 Study Identifier
      RO7198457, Pembrolizumab Treatments
      Advanced Melanoma Condition
      Official Title

      A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of RO7198457 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced Melanoma

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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.

      For the latest version of this information please go to www.forpatients.roche.com

       

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