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Clinical Trial 20557

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT03815058

Phase: Phase II
Principal Investigator: Tarhini, Ahmad

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Study Title

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



Objectives: This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma. Specific objectives and corresponding endpoints for the study are outlined below. Primary Efficacy Objective The primary efficacy objective for this study is to evaluate the efficacy of RO7198457 plus pembrolizumab compared with pembrolizumab alone on the basis of the following endpoints: & 61623; PFS after randomization, defined as the time from randomization to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)




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

    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

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