A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

  • Melanoma
Trial Status:

Recruiting

This trial runs in
Cities
  • Barcelona
  • Duarte
  • Houston
  • Lombardia
  • Madrid
  • Marseille
  • Napoli
  • Nedlands
  • Pamplona
  • Paris
  • Santa Monica
  • Siena
  • Tampa
  • Toulouse
  • Villejuif
  • Wollstonecraft
Trial Identifier:

NCT05116202 BO43328

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT05116202 , BO43328 Trial Identifier
      Nivolumab, Ipilimumab, RO7247669, Atezolizumab, Tiragolumab Treatments
      Melanoma Condition
      Official Title

      A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      Inclusion Criteria for Cohort 1:

      • ECOG performance status (PS) of 0 or 1
      • Histologically confirmed resectable Stage III melanoma according to AJCC-8 and no history of in-transit metastases within the last 6 months
      • Fit and planned for CLND
      • Measurable disease according to RECIST v1.1
      • Availability of a representative tumor specimen
      • Adequate hematologic and end-organ function
      • For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
      • Negative HIV test, negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test, and negative hepatitis C virus (HCV) at screening.

      Inclusion Criteria for Cohort 2:

      • ECOG PS of 0 or 1
      • Life expectancy >= 3 months, as determined by the investigator
      • Histologically confirmed Stage IV (metastatic) cutaneous melanoma according to AJCC-8
      • Disease progression during or following at least one but no more than two lines of treatment for metastatic disease
      • Measurable disease according to RECIST v1.1
      • Availability of a representative tumor specimen
      • Adequate hematologic and end-organ function
      • For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
      • Negative HIV test, negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test, and negative hepatitis C virus (HCV) at screening.
      Exclusion Criteria

      Exclusion Criteria for Cohort 1:

      • Mucosal, uveal and acral lentiginous melanoma
      • Distantly metastasized melanoma
      • History of in-transit metastases within the last 6 months
      • Prior radiotherapy
      • Prior immunotherapy, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, and other systemic therapy for melanoma
      • Treatment with investigational therapy within 28 days prior to initiation of study treatment
      • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
      • Prior allogeneic stem cell or solid organ transplantation
      • Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment
      • Active or history of autoimmune disease or immune deficiency
      • Exclusion Criteria for Cohort 2:

        • Mucosal and uveal melanoma
        • Treatment with investigational therapy within 28 days prior to initiation of study treatment
        • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
        • Prior allogeneic stem cell or solid organ transplantation
        • Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment
        • Active or history of autoimmune disease or immune deficiency
        • Symptomatic, untreated, or progressing CNS metastases
        • Active or history of carcinomatous meningitis/leptomeningeal disease
        • Uncontrolled tumor-related pain
        • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
        • Uncontrolled or symptomatic hypercalcemia

      About Clinical Research

      What is a clinical trial? Why should I consider taking part in a clinical trial? And why does Genentech conduct clinical trials?

      Find out now